MDMA Breaking News

August 22, 2010

Canadian MDMA/PTSD Study Gains Institutional Affiliation

On July 19, 2010, Health Canada informed principal investigator Ingrid Pacey, M.D. that they would accept a letter from the director of the University of Victoria’s (UVic) Center for Addiction Research of British Columbia (CARBC) as proof of affiliation with UVic/CARBC. This was a major hurdle in getting the Canadian MDMA/PTSD study started. In Switzerland and the U.S., we have been able to conduct our research without any outside institutional affiliation, but Health Canada required affiliation with a Canadian institute before we could import MDMA for the study. We had obtained approval for the actual protocol from both Health Canada and a Canadian Institutional Review Board (IRB) by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we were not deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.

On July 22, 2010, Tim Stockwell, Ph.D. the Director of CARBC, sent a letter to Health Canada confirming CARBC’s support and affiliation with Dr. Pacey. In the letter, Stockwell wrote, “I have reviewed the paper about the results of the [MAPS-sponsored] U.S. MDMA/PTSD study… As a result, I found the results to be promising and think it is of significant scientific importance that a Canadian MDMA/PTSD study is conducted to see if the results can be replicated with a new co-therapist team in a new location.”

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August 20, 2010
  National Post "Research Awaits Ecstasy Approval" by Terrine Friday.

This article from a Canadian paper did not choose the best quote from Rick Doblin to express his position on MDMA-assisted psychotherapy for PTSD compared to conventional pharmaceutical drugs. While conventional pharmaceuticals drugs treat the symptoms of PTSD, Rick would characterize MDMA-therapy as a method for treating the causes of PTSD, thereby healing the trauma. It is disappointing to read Canadian Forces Surgeon General wrongfully generalize our research as “hype.”

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August 13, 2010

Canadian MDMA Import Under Review

Mark Kozlowski, Acting Manager of the Licenses and Permits Division of the Office of Controlled Substances at Health Canada informed Ingrid Pacey, M.D. that his office has begun a review of the application for Kerrisdale Pharmacy to obtain a controlled substances license. If they approve a license for Kerrisdale Pharmacy, MAPS will move forward with importing the MDMA for our Canadian study from Switzerland to Canada. 

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August 10, 2010

Psychological effects on healthy volunteers/therapist-training study recruiting therapists

On October 3, 2009, the FDA approved our protocol for studying the effects of MDMA on healthy volunteers. On December 21, 2009, the protocol was approved by the IRB. In this study the Mithoefers will administer MDMA to healthy volunteers who are part of our therapist-training program. The goal of this study is two-fold: (1) the study will allow us to learn more about the psychological effects of MDMA-assisted psychotherapy in healthy individuals; and (2) the therapists in our training program will have the opportunity to have a firsthand experience with MDMA-assisted psychotherapy, which we suspect will enable them to be better therapists when they administer MDMA to a subject in one of our future studies.

We are anticipating that we will need about 20–30 therapist teams in approximately three years for our two large-scale, multi-site, Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. Applications are encouraged from therapists with some or all of the following qualifications: 1) treated patients with PTSD, 2) worked with non-ordinary states of consciousness, and/or 3) conducted clinical research. Applications from male/female teams are highly encouraged. If interested, please contact Berra Yazar-Klosinski, Ph.D. at: .(JavaScript must be enabled to view this email address)

 

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August 9, 2010

Mithoefer Receives DEA License for Phase 1 Psychological Effects/Therapist Training Study; License for U.S. MDMA/PTSD Veterans Study Coming Soon

On August 9, Michael Mithoefer, M.D., received a Schedule I license from the Drug Enforcement Administration (DEA) to administer MDMA in our Phase 1 study to investigate the effects of MDMA on healthy volunteers (limited to thera- pists enrolled in our therapist-training program). He waited approximately seven months to receive the license. This is a relatively short period compared with 19 months last time he was licensed. The DEA also told Dr. Mithoefer to expect his license for our Veterans study soon, which would be only 4 months from the time of application. The FDA and Institutional Review Board (IRB) approved both of these studies months ago, so we’ve just been waiting on the DEA’s Office of Drug and Chemical Evaluation (ODE) to issue the licenses. The studies are co-lead by Ann Mithoefer, B.S.N.

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August 3, 2010
  Australian Broadcasting Corporation News "Ecstasy May Help Traumatised Veterans" .

“United States scientists say the drug ecstasy may help war veterans suffering from post traumatic stress disorder.” Reports this Australian news source.

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August 1, 2010

Switzerland MDMA/PTSD One-Year Follow-Up Study Proceeds

On January 8, 2010, the last of the experimental treatments were completed in the Swiss MDMA/PTSD study. The study, led by principal investigator Peter Oehen, M.D., with
co-investigator Verena Widmer, R.N., treated 12 subjects with chronic, treatment-resistant PTSD. The investigators are currently collecting data for the one-year, long-term follow-up phase of the study. Eight subjects have already completed the long-term follow-up, three subjects have not yet done so, and sadly, one subject has died from an unrelated cause.

On June 14, 2010, at our office in Santa Cruz, CA, volunteer clinical research intern Tim Whalen finished building and validating the database for this study. On July 19, volunteer research intern Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology) finished entering the preliminary data into the database. Katharina Kirchner, M.A., who is assisting our Swiss end-of-life anxiety study, will also assist the investigators of this study with resolving data queries. The final analysis is scheduled for completion in January 2011, after the last measurements are collected from the final subject. We anticipate that the results will be submitted for publication in Spring 2011.

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August 1, 2010
  DailyNewsToday "Research Finds Ecstasy helps treat PTSD" .

A brief article discussing the outcomes of the recent MDMA-PTSD pilot study.

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July 31, 2010
  Lifestyle.com "Psychedelic Psychotherapy for the Treatment of Alcohol and Drug Addiction Now Available at Eleusis" by Pamala Duncan.

This articles discusses the Eleusis drug addiction treatment center and the role of ketamine in helping people overcome addictions.

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July 31, 2010
  Epagini.com "Ecstasy, treatment for soldiers suffering from post traumatic stress disorder" .

This article is brief and discusses the MDMA-PTSD pilot study.

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July 30, 2010
   "138 articles about mdma/ptsd therapy" .

The Journal of Psychopharmacology's publication of MAPS' MDMA/PTSD study led to at least 138 media articles!

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July 27, 2010

Long-term Follow-up of U.S. MDMA/PTSD Pilot Study is Complete

On July 27, 2010, MAPS Deputy Director Valerie Mojeiko and Clinical Research Associate Berra Yaza-Klosinski, Ph.D. completed data collection for the long-term follow-up to our flagship U.S. MDMA-assisted psychotherapy for PTSD study led by Principal Investigator Michael Mithoefer, M.D. and Co-Investigator Ann Mithoefer, B.S.N. in Charleston, SC. Independent rater Mark Wagner, Ph.D., from the College of Medicine, Department of Neurology, collected Clinician-Administered PTSD Scale (CAPS) measurements from 17 of the 20 subjects who received treatment. All 20 subjects filled out a questionnaire developed internally to assess long-term effects. The average length of time between the final experimental treatment session and the follow-up data collection was three and a half years. Preliminary analysis of the results suggests the benefits of the treatment were maintained. MAPS’ clinical research volunteers are inputting data into a validated database at the MAPS office in Santa Cruz, CA. After the data is analyzed, Dr. Mithoefer, et al, will write a new paper for submission to a scientific journal around the end of 2010.

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July 22, 2010
  Medscape. "Ecstasy-Assisted Psychotherapy May Help Patients With Treatment-Resistant PTSD" by Deborah Brause.

The South Carolina Phase II MDMA study results are reviewed in this article with great depth and detail, and includes comments and criticisms by participating researchers and other medical professionals.

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July 21, 2010
  Online-International News Network "Ecstasy ‘may help trauma victims" .

A Pakistan based news network reports on the recent MDMA findings, another example of the considerable amount of exposure the study is getting.

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July 20, 2010
  Time "Ecstasy Shows Promise in Relieving PTSD" by John Cloud.

Time reports on the recent study, MDMA's potential as a medication, and comments that the recently published paper on the results “represents the first time in a generation that psychedelic drugs have been taken seriously as treatment.”

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July 19, 2010
  New Scientist "Ecstasy may help trauma victims" by Arran Frood.

This balanced article discusses MAPS' PTSD research and the prospect of having MDMA a legal drug for therapy in the future. The author also offers caution that this is still an early investigation and that more research is needed.

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July 19, 2010
  UK National Health Service "Ecstasy Tested for Trauma Therapy" .

This article by the UK's National Health Service gives a good critique of MAPS Phase II pilot-study of MDMA-assisted psychotherapy for the treatment of PTSD.

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July 19, 2010

Journal of Psychopharmacology publishes paper about MAPS-sponsored U.S. MDMA/PTSD pilot study

The Journal of Psychopharmacology published a paper about the MAPS-sponsored U.S. MDMA/PTSD pilot study.The paper is titled, "The safety and efficacy of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study," and is authored by Michael Mithoefer, M.D., Mark Wagner, Ph.D., Ann Mithoefer, B.S.N., Lisa Jerome, Ph.D. and Rick Doblin, Ph.D.

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July 15, 2010

Recruiting Subjects for MDMA/PTSD Study in War Veterans; Awaiting DEA Review

We are now in the process of recruiting subjects for our study of MDMA-assisted psychotherapy for veterans with war-related PTSD. We are mostly seeking veterans from Iraq and Afghanistan but are looking for a few from Vietnam as well. The study, to be conducted by Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., will be our second MDMA/PTSD study to take place in Charleston, SC. The Mithoefers' previous study of MDMA-assisted psychotherapy included subjects whose PTSD was primarily the result of sexual assault, abuse and violent crime, with just two veterans with war-related PTSD. This new study will only enroll veterans with war-related PTSD. We will also be able to enroll subjects with the previously excluded risk factors of Hepatitis C or controlled hypertension, with additional screening evaluations and safety measures for these subjects.

The final hurdle before the study is able to move forward is that Dr. Mithoefer must obtain a renewed Schedule I license to handle the MDMA required for the study. He has already been waiting over 3 months on the DEA's Office of Drug and Chemical Evaluation (ODE) to complete its review of his license application, which he submitted after obtaining both FDA and IRB permission. Unlike the FDA, the DEA has no time limits for issuing licenses. The ODE informed us on July 13 that the review could take an additional four months or more, meaning we may have to wait until October to start the study unless we can find a way to motivate the DEA to move faster. President Obamas announcement on July 11 that it is a national priority to expedite treatment to veterans with PTSD may prove helpful.

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July 15, 2010

MDMA in Healthy Subjects / Therapist Training Study Awaits DEA Approval

Although our protocol for studying MDMAs effects on healthy volunteers was approved by the FDA on October 3, 2009, and by the IRB on December 21, 2009, we are still waiting on the DEA's Office of Drug and Chemical Evaluation (ODE) to provide Michael Mithoefer, M.D. with a Schedule 1 license for this study. In this study, Principal Investigator Dr. Mithoefer and co-therapist Ann Mithoefer, B.S.N., will be administering MDMA to healthy volunteers who are part of our therapist-training program. The study will also allow us to learn more about the effects of MDMA in healthy individuals, as opposed to patients with chronic, treatment-resistant posttraumatic stress disorder (PTSD). We expect that, as with the study in veterans of war with PTSD, the ODE will grant approval based on Dr. Mithoefers excellent track record. The ODE told Dr. Mithoefer that he could expect to have his license in the mail by June 9, though it has not yet arrived. On July 13, the ODE told MAPS Executive Director Rick Doblin, Ph.D. that the approval letter would be coming soon.

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July 14, 2010

Long-Term Follow-Up of U.S. MDMA/PTSD Pilot Study Nears Completion

Our long-term follow-up to our flagship study of MDMA-assisted psychotherapy for the treatment of PTSD, which has been taking place in Charleston, SC, is coming close to completion. All that remains is for the researchers, led by Principal Investigators Michael Mithoefer, M.D. and co-therapist Ann Mithoefer, B.S.N., to collect follow-up information from a few more subjects. Weve already obtained long-term follow-up data from 16 of the 20 subjects, at an average of about 3 years after their final experimental session. The results so far are encouraging.

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July 13, 2010

Swiss MDMA/PTSD One-Year Follow-Up Study Continues; Data Collection Underway

The experimental treatment portion of our Swiss study of MDMA-assisted psychotherapy for PTSD ended in January 2010. The long-term (one year) follow-up portion of the study is currently underway and will be concluded in January, 2011.

Our new volunteer research intern, Audrey Redfield, Ph.D. candidate (Institute of Transpersonal Psychology), is entering the completed data from the Swiss study into the clinical database at our office in Santa Cruz, CA. Audrey is now entering data from the ninth subject, out of 14 enrolled (12 completed and 2 drop-outs). In the interest of timeliness and accuracy, we will be checking the data as we go.

By the end of August 2010, we expect that this preliminary data entry will be completed. As the remaining subjects complete the long-term follow-up measures, we will be adding their data to the database. The final analysis will be completed shortly after the final subject participates in the long-term follow-up in January 2011. We are tentatively planning to complete the writing of a paper for publication in the spring of 2011.

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June 28, 2010

Doblin, Mithoefers, and Richards present at 17th International Transpersonal Conference in Moscow

From June 23-27, the 17th International Transpersonal Conference took place in Moscow. Vladimir Maykov, Ph.D. and Stanislav Grof, M.D. organized the conference. MAPS was represented by Michael Mithoefer, M.D., Annie Mithoefer, B.S.N. and Executive Director Rick Doblin, Ph.D. MAPS also sponsored the attendance of distinguished psychotherapist and researcher William Richards, Ph.D., from the Johns Hopkins psilocybin research team funded by the Council on Spiritual Practices and the Heffter Research Institute. Also in attendance was Evgeny M. Krupitsky, M.D., Ph.D, who along with Rick chaired the panel on psychedelic research.

In the 1990s, Dr. Krupitsky was the only researcher in the world conducting legal psychedelic psychotherapy studies; he was investigating ketamine-assisted psychotherapy as a treatment for alcoholism and heroin addiction. Sadly, in 2002, the Russian government ended his research and to this day psychedelic research is completely forbidden in Russia. Despite this obstruction of scientific freedom, the Russian and international attendees were especially eager to hear the speakers discuss psychedelic research taking place in the U.S.

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June 20, 2010
International Federation of Psychotherapy Congress in Lucern, Switzerland hosts Mithoefers, Gasser, Oehen, and Passie

From June 16-19, the International Federation of Psychotherapy convened a Congress in Lucerne, Switzerland. As a sign of the growing acceptance of psychedelic psychotherapy research, this mainstream psychotherapy conference had a seminar devoted to the topic. From the U.S., MAPS sent researchers Michael Mithoefer M.D. and Annie Mithoefer, B.S.N. to present information from our U.S. MDMA/PTSD study. MAPS also brought Swiss MDMA/PTSD researchers Peter Oehen, M.D. and Verena Widmer, R.N. and Swiss LSD/end-of-life researcher Peter Gasser, M.D. Also on the panel was renowned German psychedelic researcher Torsten Passie, M.D. This was the first presentation about new data from psychedelic psychotherapy research to a mainstream psychotherapy conference in over 35 years.

Out of about 800 attendees at the conference, approximately 50 people crowded the room for the two-hour panel. According to MAPS Executive Director Rick Doblin, Ph.D. who also attended the conference, the session on psychedelic research was remarkable because it wasnt remarkable it was a mainstream psychotherapy conference that happened to have a panel on psychedelic psychotherapy research. There were no protestors or vocal dissenters. The promising results were taken seriously and our call for expanding research wasnt even considered controversial.

During the trip to Switzerland, MAPS supporter and friend Vanja Palmers hosted Rick and the Mithoefers at his home in Lucerne, only several blocks from the conference center.

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June 16, 2010
  San Francisco Chronicle "On Dangerous Meds, the Feds and ’Heads’" by Eugene Schoenfeld.

Psychiatrist Schoenfeld, author of this opinion piece, remarks on two deaths that took place at a rave in San Francisco over Memorial Day Weekend. He points out "Due to federal government interference, we don’t know how best to prevent harm at raves other than to just say no to drugs, obviously and tragically an ineffective strategy." Schoenfeld mentions Julie Holland M.D.'s presentation at Psychedelic Science in the 21st Century.

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June 14, 2010

Canadian MDMA/PTSD Study Still Seeking Permission to Import MDMA; Protocol Amendment Being Submitted

We seem to be making slow, gradual progress in getting our Canadian MDMA/PTSD study started. On June 14, 2010, Principal Investigator Ingrid Pacey, M.D., met in person with Health Canada officials in Ottawa. Wed previously been informed that Health Canada requires that we she officially affiliated with a Canadian research institution (and not just with MAPS). Prior to the June 14th meeting, Dr. Pacey had obtained affiliation with two different research institutes, the University of Victorias (UVic)Center for Addiction Research of BC(CARBC) and the University of British Columbias (UBC)Center for Health Evaluation and Outcome Studies(CHEOS),and had provided this information to Health Canada.

The new information that Dr. Pacey was told on June 14 was that we must obtain written proof of affiliation from the Dean of either of the two Universities with which these research institutions are affiliated. This seems to be a politically motivated requirement since the research institutes have already approved our affiliation. In the U.S. and Switzerland, weve been able to conduct our research without any outside institutional affiliation. In any case, Dr. Pacey and the research organizations will be seeking to obtain approval from the Deans of UBC and UVic. We are pursuing both options simultaneously since approval from either of the Deans is difficult to predict. Wed obtained approval for the actual protocol from both Health Canada and a Canadian IRB by March 2009, so this delay for institutional affiliation has been especially prolonged and frustrating. Fortunately, we have not been deterred from continuing to strive for full approval for what will become the first psychedelic research study to take place in Canada in almost 40 years.

While we wait for institutional affiliation that will satisfy Health Canada, along with permission to import MDMA to start the study, MAPS is submitting an amendment to the original research protocol to Health Canada. We are adding additional long-term (one year) measurements of the effectiveness of MDMA-assisted psychotherapy for PTSD, as well as a new measurement that the FDA now requires for evaluating long-term suicidality in subjects taking any psychiatric drug, known as the Columbia-Suicide Severity Rating Scale (C-SSRS).

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May 25, 2010

MAPS Research Specialist Ilsa Jerome Responds to Report that Ecstasy Damages Brain Cells

CBC News reported that “the brains of ecstasy users show low levels of a certain protein, a finding that may explain why many feel they need to turn to higher doses of the drug. This was based on findings reported in the Journal Brain.

 

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May 22, 2010

Switzerland MDMA/PTSD One-Year Follow-Up Study Proceeds

The Swiss MDMA/PTSD study, led by Principal Investigator Peter Oehen M.D. with co-investigator Verena Widmer, R.N., has completed all experimental treatments and is currently in the one-year follow-up phase. The experiential portion of the study was completed in January 2010. Six subjects have completed the long-term follow-up, one subject has withdrawn from the long-term follow-up, and five subjects are yet to complete this portion of the study.

MAPS has built a new database to store the data for this study and the database has been verified for accuracy. We are now recruiting an intern or two to assist with data entry from this study. We will be choosing interns amongst applicants who pass stringent tests of accuracy in data entry. Katharina Kirchner, M.A. who is assisting our Swiss LSD/end-of-life anxiety study, will also be assisting the investigators of this study with data entry and data clean up. We anticipate that the data entry will take two months to complete, with additional time required to ensure accuracy of data in the database. The final analysis won’t be completed until the study ends at the beginning of 2011.

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May 21, 2010

  US MDMA/PTSD Veterans of War Study Awaits FDA’s Controlled Substance Staff to Approve Researcher and Protocol

Our study of MDMA-assisted psychotherapy for the treatment of PTSD in veterans of war is waiting for the FDA’s Controlled Substances Staff (CSS) to complete its review of the qualifications of the investigator (Michael Mithoefer, M.D.) and to evaluate the protocol from a diversion control perspective. Since Dr. Mithoefer held a DEA Schedule 1 license for our flagship MDMA/PTSD study and conducted an excellent study with all MDMA properly accounted for, the review by the CSS will almost certainly be favorable. Unfortunately, there is no time limit on how long the CSS can take to review protocols, so we can only wait for CSS to focus on our study.  After the CSS approves the investigator and protocol, then the DEA must renew the Schedule 1 license of MAPS’ lead investigator Michael Mithoefer, M.D. and give him permission to order more MDMA for the new study. We hope to start this study soon.

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May 20, 2010
Health Canada Official to Meet With MDMA/PTSD Researcher Ingrid Pacey, M.D.

An official with Health Canada is working to schedule a meeting in June with MAPS-sponsored researcher and Principle Investigator Ingrid Pacey M.D., to discuss the remaining issues in the authorization process for our MDMA/PTSD study. Frustratingly, our research project in Vancouver, with co-therapists Pacey and Andrew Feldmar, M.A., has been on hold since March 2009, when Dr. Pacey filed for her authorization to administer the MDMA. We had been under the impression that our application to import the MDMA for the study was ready to be approved since we had obtained approval of the protocol from a Canadian Institutional Review Board (IRB) and Health Canada. However, Dr. Pacey heard nothing for many months and then, in November 2009, was informed that before she could be authorized to administer the MDMA and before we could apply for a permit to import MDMA, we needed to obtain affiliation with a Canadian institution. In February 2010, Dr. Pacey obtained institutional affiliation, and in March 2010, she notified Health Canada of this affiliation, again hearing nothing for several months. We are hoping this upcoming meeting with Health Canada will clearly outline the remaining steps we must take before the MDMA can be imported and the study can begin. While it has been discouraging to have waited over a year since the protocol itself was fully approved, we are hopeful that Health Canada will move forward with our effort to start the first psychedelic research project in Canada in over 35 years.

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May 9, 2010

  U.S. MDMA/PTSD Paper Revised and Resubmitted; Long-Term Follow-Up Study Continues

On Sunday May 9, a manuscript about our flagship U.S. MDMA/PTSD pilot study was resubmitted to a peer-reviewed journal after receiving initial responses to the original submission from four reviewers. We should learn in the next several weeks if this version of the paper, or a slightly modified version, will be accepted for publication. If so, it will be cause for major celebration since this would become the first published paper about a completed study of MDMA-assisted psychotherapy for PTSD.  The authors of the paper include Principal Investigator Michael Mithoefer M.D., Mark Wagner, Ph.D., Annie Mithoefer B.S.N., Ilsa Jerome, Ph.D. and Rick Doblin, Ph.D.  While our drug development effort does not require the publication of the results of our research in peer-reviewed scientific journals, our public education efforts will be greatly enhanced if we can manage to publish our results.

The long-term follow-up study for this research project is still ongoing, with just a few additional subjects still to be assessed. The remaining data on long-term effects of MDMA-assisted psychotherapy to be collected from the subjects is extremely valuable to the final data analysis and submission to the FDA.  Preliminary results from the long-term follow-up are encouraging.

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May 4, 2010

Amendment to LSD Protocol Submitted to Swiss Ethics Committee

On May 4, 2010, Peter Gasser, M.D. submitted an amendment to our Swiss LSD/end-of-life anxiety study to his Ethics Committee (EC). The EC will meet on May 25 to evaluate the amendment. The amendment requests that we 1) include audio and video recording of the treatment sessions for later analysis, 2) add interim data analysis in order to get a sense of the safety and effectiveness of treatments before the study is over, and 3) make the protocol more flexible to meet the needs of the study population, which are people with advanced-stage cancer or other life-threatening diseases. Often these subjects have difficulties leaving home because of pain. As a result, we would like to expand some of the timelines in the current version of the protocol in order to be more flexible with the subjects.

Currently, the eighth subject out of 12 has been enrolled, with the eighth subject’s experimental treatment to take place soon. We are also adding a new clinical study assistant to the staff, Katharina Kirchner, M.A. of Switzerland. She will assist with data entry for this study and for our Swiss MDMA/PTSD study.

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May 2, 2010

Jordanian MDMA/PTSD Team Participates in Training Program/Conference

Our Jordanian MDMA/PTSD team, led by Nasser Shuriquie, M.D., participated in a six-day therapist-training program conducted by Michael Mithoefer, M.D. and Annie Mithoefer B.S.N. in Charleston, South Carolina. The Jordanian team, which included Tayseer Shawash, Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social worker Rudiana Abubaker, then traveled to San Jose to attend our conference, Psychedelic Science in the 21st Century.

Our clinical research team has drafted a second amendment to the protocol for our Jordanian MDMA/PTSD study. The new amendment increases collection of safety information. We will send this amendment to the Jordanian IRB in the coming weeks.

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May 1, 2010
Second MDMA/PTSD Therapist Training Program, Soliciting More Applicants

From April 7 to 12, Michael Mithoefer, M.D., and Annie Mithoefer B.S.N. led an MDMA/PTSD therapist-training program with eight attendees in South Carolina. The group reviewed our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was reviewing videos from past experimental psychotherapy sessions from our first U.S. MDMA/PTSD study. This training program, and those planned for the future, will be used to teach applicants to conduct our future research projects. Applicants who complete the non-drug training program and satisfy screening criteria may have the opportunity to take MDMA in a therapeutic setting as part of our Phase 1 study to investigate the effects of MDMA on healthy volunteers; this study is also designed to give therapists subjective experiences of what MDMA therapy is like.

We are anticipating that we will need more therapist teams in approximately three years, if and when we start our Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. If interested please contact Berra Yazar-Klosinski, Ph.D. at: .(JavaScript must be enabled to view this email address)

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May 1, 2010

Second MDMA/PTSD Therapist Training Program, Soliciting More Applicants

From April 7 to 12, Michael Mithoefer, M.D., and Annie Mithoefer B.S.N. led an MDMA/PTSD therapist-training program with eight attendees in South Carolina. The group reviewed our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was reviewing videos from past experimental psychotherapy sessions from our first U.S. MDMA/PTSD study. This training program, and those planned for the future, will be used to teach applicants to conduct our future research projects.  Applicants who complete the non-drug training program and satisfy screening criteria may have the opportunity to take MDMA in a therapeutic setting as part of our Phase 1 study to investigate the effects of MDMA on healthy volunteers; this study is also designed to give therapists subjective experiences of what MDMA therapy is like.

We are anticipating that we will need more therapist teams in approximately three years, if and when we start our Phase 3 studies. Since the training program can take a long time, we are currently soliciting more applications from qualified therapists interested in conducting clinical research with MAPS. If interested please contact Berra Yazar-Klosinski, Ph.D. at: .(JavaScript must be enabled to view this email address)

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April 23, 2010
  Yahoo News "Psychedelic trips aid anxiety treatments in study" by Malcolm Ritter.

This article discusses one subject's treatment with psilocybin as part of the NYU psilocybin/cancer anxiety research project, as well as mentioning the Psychedelic Science in the 21st Century conference. Rick Doblin, Ph.D., Steve Ross, M.D., and David Nichols, Ph.D. are each quoted.

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April 21, 2010
  CNN "Psychedelic Drugs For Your Health" by Campbell Brown and Sanjay Gupta, M.D..

Watch it on the on the MAPS website (or fullscreen on CNN's website.)

This is one of many great media pieces that arose from the Psychedelic Science in the 21st Century conference. This television news piece features interviews with Steven Ross, M.D. from the NYU psilocybin/cancer research team and CNN health correspondent Sanjay Gupta, M.D.

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April 20, 2010
  CNN "MOV File" by .
CNN. "Science Takes a New Look at Psychedelics." With Correspondent Dan Simon.

This television news article features short interviews with Rick Doblin and Michael Mithoefer, and coverage of the Psychedelic Science in 21st Century conference.

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April 13, 2010

Jordanian MDMA/PTSD Research Team Visited U.S. for Training

From April 7-12, 2010, our Jordanian MDMA/PTSD team, led by Nasser Shuriquie, M.D., participated in a six-day therapist-training program conducted by the Mithoefers in Charleston, SC. The Jordanian team consisted of Tayseer Shawash, Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social worker Rodina Abubaker. The training included a review of our treatment manual in order to learn how to conduct therapy in accordance with our treatment method. A major portion of the training was viewing videos from our first U.S. MDMA/PTSD study. Now that the team has participated in the non-drug training, each team member has the option to experience MDMA by participating in our Phase 1 study of the psychological effects of MDMA administered in a therapeutic setting to healthy volunteers.

On April 13, the Jordanian team traveled from Charleston, SC, to San Jose, CA, to attend our conference, Psychedelic Science in the 21st Century, and a post-conference workshop led by Stan Grof, M.D.

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April 3, 2010

Update on the Jordanian MDMA/PTSD Study

The Jordanian MDMA/PTSD study that MAPS is sponsoring has been approved by the Jordan IRB, and will soon be submitted to the Jordanian FDA. A team of five Jordanians from Al-Rashid Hospital in Amman will be coming to the United States from April 6th to 12th for an MDMA/PTSD therapist-training session, which will be held in Charleston, South Carolina and taught by Michael Mithoefer M.D. and Annie Mithoefer B.S.N. MAPS Executive Director Rick Doblin will be there on the first day of their arrival to welcome them all to the U.S., to express his appreciation for their coming to learn about MDMA, and to let them know how important their project is to MAPS. After the MDMA/PTSD therapist-training seminar, the five Jordanians from the Al-Rashid Hospital will travel to San Jose, California to participate in our Psychedelic Science in the 21st Century conference.

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April 2, 2010

MAPS Closes Initial Phase of Israeli MDMA/PTSD Study

In our Israeli MDMA/PTSD study, weve currently completed a preliminary analysis of the data. All five of the subjects enrolled to date have been treated without any evidence of harm. However, while there is some evidence of efficacy, its minimal. Weve decided to close out this initial study and postpone new treatments until we have obtained adequate therapeutic training for members of our Israeli co-therapist team.

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April 1, 2010

MAPS Continues Protocol Development and Planning of Spanish MDMA/PTSD Study

In Spain, MAPS is in the protocol development stage for a study being conducted by Jose Carlos Bouso, Ph.D., Jordo Riba, Ph.D., and Manel Barbanoj M.D. Weve agreed upon the protocol design with this team of researchers, and were now in the process of elaborating it into a full protocol for submission to their Hospitals Institutional Review Board, and then the Swiss Ministry of Health.

Once approved, this study will mark our overcoming the political suppression of our early MDMA/PTSD study in Spain. Jose Carloss MAPS-sponsored study in Madrid had been the worlds first MDMA/PTSD pilot study, started in 2000 and shut down in 2002 by the Madrid Anti-Drug authorities for political reasons. Weve posted more information about the history of our early MDMA/PTSD study in Spain, as well as a paper by Jose Carlos Bouso, reporting on the results that we were able to obtain.

This study will be the only one of our pilot studies that uses an active placebo thats not MDMA. In this study, well be testing d-amphetamine as the active placebo. Were also going to be intensely focusing on evaluating videotapes of the first several therapy sessions using our adherence criteria for our revised treatment manual.  All of our MDMA/PTSD studies now will start with a more intensive review of the videotapes of the first several sessions by raters to quantify therapist adherence to the therapeutic method. Over time, this should help us to make our training of therapists more effective, which will make our treatment itself more effective.

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March 31, 2010

Monitoring Visit Conducted on Swiss MDMA and LSD Studies

In late February, MAPS Clinical Operations Manager Amy Emerson, Deputy Director Valerie Mojeiko, and MAPS new clinical research specialist Berra Yazar Ph.D., conducted a monitoring visit in Switzerland. They worked with Peter Oehen M.D. on the Swiss MDMA/PTSD study, which has completed treating all 12 patients, to help prepare the data for reporting to Swiss Medic and the FDA, and also for writing an article for submission to a scientific journal.

This same team also paid a monitoring visit to Peter Gasser M.D.s MAPS-sponsored Swiss LSD/end-of-life study. The monitoring visit revealed that its more difficult than we had originally anticipated to work with people who are close to dying, because their underlying disease process affects their health and their anxiety, as well as their ability to come to the psychotherapy sessions on a schedule.

Swiss LSD researcher Peter Gasser had a teleconference with Rick Doblin, Ph.D., MAPS Research and Information Specialist Ilsa Jerome, Ph.D., and MAPS Clinical Research Associate Berra Yazar, Ph.D. They discussed ways to align the windows during which certain procedures should be taking place with the diminished abilities to keep to a schedule of the actual patient population that they are working with.

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March 26, 2010

MDMA/PTSD Study in Israel Paused; Prospect of Revised Israeli Study Being Investigated

On March 26, 2010, we closed our Israeli MDMA/PTSD study to new subjects in order to provide more training to the therapeutic teams and to our independent rater, to improve our data collection processes, and to make several improvements to the protocol. There were no Serious Adverse Events (SAEs) and all patients had been treated without evidence of harm. We have conducted preliminary analysis of the data from the five subjects who were treated and found self-reports of healing, but quantitative measures did not correspond. Rick will visit Israel in October to discuss procedures for restarting the study with Principle Investigator Moshe Kotler, M.D. Though recruitment had been slow, an official at the Israeli Defense Forces indicated a willingness to refer soldiers with war-related PTSD once we restart the study. We have learned from the Israeli study that we need to provide all of our therapist teams with enhanced training about MDMA-assisted psychotherapy, protocol adherence, and data collection, prior to a study’s initiation. We also have learned that we need a single, dedicated research coordinator for each site.

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March 24, 2010

Swiss MDM/PTSD Study Completes Active Treatment Phase

Our Swiss MDMA/PTSD study has now completed active treatment of all 12 subjects and has obtained data from the two-month follow-up. The long-term follow-up (12 months post-treatment) is still underway, and will not be completed until January 2011.

The results were promising, approaching significance but only reaching the .1 level. The underlying reduction in PTSD symptoms was larger than the reductions obtained in the Zoloft and Paxil studies, which led to their approval by the FDA for the treatment of PTSD. If this study had been somewhat larger with more subjects, the results we obtained would become significant.

The leading researcher in this study, Peter Oehen, M.D., will be reporting on his results from this study at the upcoming Psychedelic Science in the 21st Century conference.

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March 22, 2010

MAPS Clinical Plan for End-of-Phase 2 Meeting with the U.S. FDA to Develop MDMA as a Prescription Medicine for PTSD

On Monday, March 22, MAPS received final approval from our Institutional Review Board (IRB) to move forward with our new MDMA/PTSD study.  Michael Mithoefer, M.D. and Annie Mithoefer, BSN will conduct this new study in Charleston, South Carolina. They both ran the previous MAPS-sponsored US MDMA/PTSD study, which successfully demonstrated both safety and efficacy in treating treatment-resistant PTSD patients with MDMA-assisted psychotherapy and produced statistically and clinically significant findings. A scientific paper about the results is currently being evaluated for publication by a journal.

In the Mithoefers previous study of 21 people suffering from treatment-resistant PTSD, only two of the subjects were military veterans, and all but three of the subjects were women who were survivors of sexual assault or childhood sexual abuse. This new study will be conducted entirely with U.S. war veterans with PTSD. This study will help us determine if our treatment can be applied to people with PTSD from different causes or if our treatment itself needs to be modified to match the cause of the PTSD. Unlike the Mithoefers first study, which only had two groups (inactive placebo and full-dose MDMA), this study will compare three doses of MDMA—30 mg, 75 mg, and 125 mg, in an effort to enhance the double-blind. Most importantly, we will be testing what may become the protocol design that will be used in our large-scale, multi-site Phase 3 studies.

Because the Mithoefers previous study was the first study of its kind, we needed to establish a baseline of potential side effects of psychotherapy alone in people with PTSD who were treated with a placebo. People who received nothing but a placebo still reported side effects, so it was important that we have a pure placebo control, otherwise any of these side effects could be attributed to the MDMA. The rightful criticism of our first study, and the primary critique of the data so far, has been that it wasnt effectively double-blind because the subjects could easily tell if they were given the active drug or a placebo. That criticism will be addressed in the Mithoefers new study, and an active placebo of low-dose MDMA is being used in our other studies abroad—in Israel, Switzerland, Canada, Spain, and Jordan.

The Mithoefers new study will be a methodological response to the primary critique of our first study. In addition to our research in the United States, MAPS is currently engaged in MDMA/PTSD studies in several other countries around the world—Switzerland, Israel, and soon Canada, Jordan, and Spain. All of these studies are intended to prepare us for an End-of-Phase 2 meeting with the FDA, the purpose of which is to come to agreement with the FDA on the design of the large-scale Phase 3 studies that we want to conduct. At the meeting, we will review our data, and explain the methodological and statistical considerations in our proposed design of a large-scale, multi-site, Phase 3 safety and efficacy trial.  Once weve come to an agreement on the design of our Phase 3 studies, if we get good results and show safety and efficacy, then the FDA will approve our application to market MDMA for PTSD patients.

The Mithoefers new study in veterans has been approved by both the FDA and the IRB, so now were waiting for the DEA to facilitate the licensing and transfer of the MDMA so we can begin this study. Michael and Annie Mithoefer will be giving a presentation about their work at the upcoming MAPS-sponsored Psychedelic Science conference in San Jose next month, and their workshop about MDMA and PTSD is already almost filled to capacity.

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March 6, 2010

Update on Canadian MDMA/PTSD and Ayahuasca Studies and the Formation of MAPS Canada

There is good news from our friends north of the U.S. border. We have obtained approval in Canada for our MDMA/PTSD study from both Health Canada (in March 2009) and a Canadian Institutional Review Board (in May 2009). However, when Principal Investigator Ingrid Pacey, M.D. applied for a license to import the MDMA, she was told that theres a Canadian law which states that, because MDMA is a controlled substance, we cannot start the study without affiliation with a Canadian institution. In the United States, with Michael Mithoefer M.D.s study, we were fortunately able to proceed without an institutional affiliation other than MAPS.

On March 6, 2010, Dr. Pacey informed Health Canada in writing that we had obtained institutional affiliation with the Center for Addiction Research (CARBC) in British Columbia, associated with the University of Victoria. MAPS is currently waiting on Health Canada for their approval of our institutional affiliation, and for the licensing of Dr. Pacey and our pharmacist, so that we can import the MDMA from Switzerland for the study and finally begin.

MAPS is currently forming a new non-profit corporation in Canada—MAPS Canada—that will allow Canadians to give tax-deductible donations that help to fund MAPS-sponsored psychedelic research. MAPS currently has an association with Tides Canada, which acts as MAPS Canadian fiscal sponsor until weve established MAPS Canada. It will be more efficient when were able to have our own organizational tax deductible status in Canada, just like we do in the U.S. So far, the Board of Directors for MAPS Canada consists of Mark Haden, Philippe Lucas, Kirk Tousaw, Robert Barnhart, Valerie Mojeiko, and Rick Doblin, Ph.D.. Were seeking one additional Canadian so that the Board will be majority Canadian.

The formation of this new organizational branch of MAPS grew out of the successful fund-raising event that MAPS had in Vancouver, British Columbia on October 24, 2009. MAPS Canada will be involved with both helping to support the MDMA/PTSD study in Vancouver, and also an ayahuasca study in the treatment of addiction, being conducted by Philippe Lucas.

This will be our first Ayahuasca study, which will be using natural plant extractions. We will explore whether Ayahuasca administered within a spiritual context can be helpful in treating people who have problems with addiction. Philippe Lucas, who is leading the study, will be speaking about this research at the Psychedelic Science in the 21st Century conference. In fact, there will be an entire track of presentations about Ayahuasca at the conference, with talks by Philippe Lucas, Stephen Beyer, and many others.

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February 19, 2010
   "Overview of amphetamine-type stimulant Deaths in the UK - Critical Review and Commentary" by Ilsa Jerome.

MAPS. "Overview of amphetamine-type stimulant deaths in the UK - critical review and commentary." By Ilsa Jerome, Ph.D.

Despite news generated by a new study authored by Schifano and colleagues, ecstasy is not especially deadly in younger people.

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January 15, 2010

MAPS MDMA Supply Analyzed for Quality

MAPS currently owns approximately 17 grams of MDMA. We are having the supply of MDMA reexamined for quality assurance. The analysis is intended to make sure that the MDMA has not degraded over time. We will be dividing the 17 grams among several new studies that we are starting. We will have to order new MDMA in the near future for future studies.

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January 14, 2010

Canadian Study Still on Hold, Waiting for Institutional Affiliation

Our MDMA/PTSD study in Canada is still on hold as we seek affiliation with an institution. Unlike our U.S. Study, which was conducted in the private offices of our principal investigator, Health Canada is requiring that our research be conducted at an institution. This has been a large disappointment for us, and an unforeseen hurdle. We had been under the impression for months that the only remaining item to take care of in order to start the study was obtaining a license to import MDMA from our supplier in Switzerland.

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January 11, 2010

Jordanian Insurance Agency Paid $6,800 to Insure MDMA Study

We have paid $6,800 to a Jordanian insurance agency in order to insure our planned MDMA/PTSD study in Jordan. All of the documents for the Jordanian study can be found on this MDMA webpage in the “MDMA/PTSD Jordan Study” section.

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January 8, 2010

Last MDMA Session in Switzerland MDMA/PTSD Study

The final session in our Swiss MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) took place on Friday, January 8, 2010. The twelfth and final subject received MDMA in the stage two open label portion of the trial, which means that he had previously received a placebo dose. Two months from this last session will be the final data gathering point in this study. One year from now will be the final date point in the long-term follow of this research.

We are pleased to report that just like our U.S. pilot study there was an excellent safety record.  There is no evidence of any harm caused to any of the subjects by administering research grade MDMA in a therapeutic setting. Preliminary data analysis suggests that the research will have statistically significant results in reduction of PTSD symptoms in the subject population.

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January 6, 2010

MAPS Plans New MDMA/PTSD Study in Spain

MAPS colleague Jose Carlos Bouso, Ph.D. Candidate, previous principal investigator of an MDMA/PTSD study in Spain, did not receive a 200,000 Euro government grant he had applied for last year. Jose had hoped to utilize the government grant to conduct a new study of MDMA-assisted psychotherapy for the treatment of PTSD.

In light of the absence of the grant, MAPS Executive Director Rick Doblin, Ph.D. had met with MAPS clinical research team to conceptualize sponsoring and designing a study in Spain for Jose to lead. The basic concept is that MAPS will fund the study for two subjects and then evaluate whether the research team is properly adhering with the protocol, data-gathering, and therapeutic method before funding additional participants. This concept is to insure that we spend our donated research funds on successful, well-managed projects.

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December 30, 2009

MDMA Therapist Training Protocol Approved by IRB (Psychological Effects of MDMA in Healthy Volunteers)

Our Institutional Review Board (IRB) has approved our protocol designed as a Phase 1 study of the psychological effects of MDMA in healthy volunteers. To view all of the documents that have entailed the approval process on this webpage look in the “MDMA/PTSD Training Protocol for Researchers/Phase 1 Psychological Effects Study” section.

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December 23, 2009

MDMA/PTSD Veteran of War Protocol Submitted to FDA

We have submitted the protocol (part 1, part 2, part 3) for our planned study of MDMA-assisted psychotherapy for the treatment of veterans of war with chronic posttraumatic stress disorder (PTSD) to the FDA. All of the documents that were submitted can be found on this “MDMA webpage in the MDMA/PTSD U.S. Study (Veterans of War)” section.

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December 21, 2009

Preliminary Documents for Jordanian MDMA/PTSD Study Submitted for Review to Clinical Research Organization

Several templates for our planned study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) have been submitted for review to Clinquest JO, a Jordanian Clinical Research Organization. These documents include, the protocol, the protocol synopsis, the case report forms (CRF), and the principal investigators CV. All of the documents for the Jordanian study can be found on this MDMA webpage in the “MDMA/PTSD Jordan Study” section.

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December 5, 2009

MDMA-Therapist Training Protocol Resubmitted to IRB

After our first therapist training protocol (cleared by the FDA as a Phase 1 study of MDMAs psychological effects on healthy subjects) was initially deferred by the institutional review board (IRB), we resubmitted the protocol to the IRB and addressed the IRBs concerns. The resubmission includes a cover letter, a deferral response, an amended informed consent form, and an amended protocol. The submission was accompanied by letters of support from University of West Georgia Psychology Professor Daniel A. Helminiak, Ph.D., and Johns Hopkins researcher William Richards, Ph.D. and a joint letter from Johns Hopkins research team Mathew Johnson, Ph.D., William Richards, Ph.D., and Roland Griffiths, Ph.D.

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December 4, 2009

Next version MDMA/PTSD Treatment Manual to be edited by Sherry Falsetti, Ph.D.

We are very pleased to have contracted Psychologist Sherry Falsetti, Ph.D. to edit MAPS MDMA/PTSD treatment manual and to create instruments to measure a therapists compliance with the manuals techniques. An important part of the MDMA-assisted psychotherapy drug development process is to assess whether therapists are administering the therapy in a uniform manner consistent with the treatment manual. Sherry brings to the position years of experience from the field of psychology and medicine working with PTSD. She has prior experience developing treatment manuals and creating compliance measures.

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December 3, 2009

Spanish MDMA Team Denied Grant New Ideas Underway for MAPS Research in European Union

Unfortunately, a several hundred thousand euro grant that MAPS colleague and Spanish Researcher Jose Carlos Bouso, Ph.D. Candidate applied for to conduct an MDMA/PTSD study in Spain was rejected. MAPS will now pursue other avenues to conduct additional MDMA/PTSD research within the European Union. One of the ideas that we plan to implement will be to have future studies use an open label dosing regimen for the first two subjects. This means that the first two subjects in a study will receive MDMA, rather than MDMA or placebo. MAPS will use this as a chance to monitor the research teams adherence to the protocol guidelines.

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December 1, 2009

Jordanian MDMA/PTSD Study Selects Insurance Provider—Protocol is Able to be Submitted to IRB

Our study in Jordan is able to move another step forward now that we have reached an agreement with a Jordanian insurance agency. Now that the study is insured we can submit the protocol to the Jordanian institutional review board (IRB). We have also reached an agreement with Principal Investigator Nasser Shuriquie, M.D. that the subjects enrolled in the study will be treatment resistant. This means that subjects will have to have previously attempted talk and drug therapy to treat their PTSD without success.

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November 10, 2009

Health Canada Places Major Hurdle in Front of MDMA/PTSD Study

After over a year of planning and preparations to conduct an MDMA/PTSD study in Vancouver, Health Canada placed a major hurdle on the study. For the past several months, we have been under the impression that obtaining a permit to import the MDMA to Canada was the only thing standing in the way of starting the study. Unfortunately we have now been told that our study needs to be conducted in conjunction with a Canadian institution, and will likely have to take place at that institution. We had previously planned for the study to take place at the private office of Principal Investigator Ingrid Pacey, M.D. We are now working to figure out the best means of affiliating Ingrid with an institution and what impact this will have on our projected budget for this study.

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October 25, 2009

MAPS Starts Sister Organization in Canada MAPS Canada!

MAPS has partnered with a few Canadian Citizens to create MAPS Canada an official Canadian non-profit and sister organization to MAPS. MAPS Canada is being created to allow Canadian Citizens to make tax-deductible donations directly to MAPS-related projects (currently MAPS has a partnership with Tides Canada for Canadian Citizens to make donations to MAPS, call our office for details). MAPS Canada will provide the thriving  Canadian psychedelic community an outlet to fund more psychedelic research projects in Canada.

The Board of Directors is likely to consist of Rick Doblin, Ph.D., Valerie Mojeiko, B.A., and Robert Barnhart of the United States and Mark Haden and Phillipe Lucas from Canada. We are approaching other Canadians to join the Board so Canadians will compose the majority of the Board. The legal documentation is underway for this project.

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October 24, 2009

Canadians Welcome MDMA/PTSD Study in Vancouver

We had an exciting fundraiser in Vancouver, British Colombia, Canada, where we raised over $10,000 for our planned Canadian MDMA/PTSD study. The benefit dinner was attended by several prominent figures in the Canadian drug policy reform movement, including former Vancouver Mayor Philip Owen, architect of Vancouvers four-pillar drug strategy Donald MacPherson, Vancouver Island City Council Member Phillipe Lucas, Drug Policy and Health Expert Mark Haden, and numerous others. MAPS is grateful to all those who attended and offered financial support!

Also while in Vancouver, MAPS Deputy Director Valerie Mojeiko conducted a second pre-study visit with Principal Investigators Ingrid Pacey, M.D. and Andrew Feldmar, M.A., and study assistant Amanda Walker.

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October 11, 2009

Progress Report: Jordan and Israel MDMA/PTSD Research

On September 30, we submitted our draft protocol, informed consent, and Case Report Forms for our Jordanian MDMA/PTSD research to Principal Investigator Nasser Shuriquie, M.D. and his Jordanian research team, and to Clinquest JO, a Jordanian Contract Research Organization (CRO). We have decided to hire Clinquest JO to monitor the study in order to limit the amount of travel and resources that our U.S. monitoring team would have to expend to travel frequently to Jordan. Furthermore, Clinquest JO helped to establish the Jordanian FDA, are culturally situated to Jordan, and speak Arabic. We are impressed with their quality of work and will be pleased to work with them. Dr. Shuriquie introduced Kamila Novak, Ph.D. of Clinquest JO to MAPS Executive Director Rick Doblin Ph.D. when Rick was in Jordan on August 13, 2009.

On October 20, Rick and Michael Mithoefer, M.D. will go to Amman, Jordan to make a presentation about the research agenda to representatives of the Jordanian FDA, Dr. Shuriquie, Shuriquies co-therapist and others who may be involved in the study. Clinquest JO will bring several clinical research staff from Egypt to hear the presentation. MAPS is excited to be venturing through the doorway to the Arabic research world.

From October 18-23, Michael and Rick will attend the conference “Future Directions in PTSD: Prevention, Diagnosis and Treatment,” put on by the Institute for Advanced Studies at the Hebrew University of Jerusalem. Michael will present a poster on MAPS MDMA/PTSD pilot study at the conference. Michael and Rick will also meet with Efrat Yasur, founder of Transcom Global, an Israeli CRO. MAPS is hiring Transcom Global to monitor our Israeli MDMA/PTSD study.

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October 9, 2009

Several MDMA/PTSD Protocol Documents Revised

In light of the results from our US MDMA/PTSD pilot study and preliminary results from our Swiss and Israeli pilot studies, we have completed an overall review of our methodology and study documents used in our studies. We have incorporated what we have learned in revised versions of our MDMA/PTSD protocols and Case Report Forms (CRFs). The revised protocols are designed to be more efficient. We have narrowed down our research focus and have eliminated some redundant outcome measures from the protocols. Weve also added a measure of suicidality required by the FDA for all studies using drugs that have psychological effects.

One of the strengths of MAPS drug development approach is our willingness to do the extra work required to incorporate lessons learned in our protocols as they are in process. This fine-tuning is the essence of what Phase 2 pilot studies are all about. They are learning opportunities for the development and design of Phase 3 multi-site studies. The Phase 3 studies will evaluate in a large number of subjects the safety and efficacy of MDMA-assisted psychotherapy for the treatment of PTSD. The outcome of these Phase 3 studies will determine if the FDA and other regulatory agencies eventually approve MDMA for prescription use.

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October 8, 2009

MAPS Next U.S. MDMA/PTSD Study in Veterans Protocol Development Proceeds

Were close to completing the protocol design for our upcoming U.S. MDMA/PTSD study exclusively for veterans of war. We plan to submit this protocol to the FDA in November 2009. A crucial protocol design meeting with Rick Doblin, Ph.D., Michael Mithoefer, M.D. and Ilsa Jerome, Ph.D. took place several weeks ago at Ricks home office. We will be using the Phase 2 study in veterans to test a possible design for our Phase 3 multi-site studies—our most sophisticated protocol design to date. We will provide more information about details of the protocol in an upcoming email newsletter.

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October 2, 2009
  Clinical Psychology Review "PDF File" by Judith Cukor, Josh Spitalnick, JoAnn Difede, Albert Rizzo, and Barbara O. Rothbaum.

Clinical Psychology Review. "Emerging treatments for PTSD." By Judith Cukor, Josh Spitalnick, JoAnn Difede, Albert Rizzo, and Barbara O. Rothbaum

This scientific, peer-reviewed paper has a section on MDMA. The authors quote an article from Rick Doblin, Ph.D. published in 2002 which was about MAPS' MDMA/PTSD Clinical Plan. They also quote Andy Parrott about MDMA's therapeutic potential, even though he has mostly written about the risks of MDMA.

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September 30, 2009

Rick Doblin was interviewed on CFAX-1070 AM, a Canadian news radio station about MAPS MDMA/PTSD research in Vancouver. Several listeners called into ask Rick questions. This can be listened to as an mp3 or wav file.

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September 16, 2009

Psychological Effects/Therapist-Training MDMA Protocol Cleared by FDA

The FDA permitted us to proceed with our clinical investigation, “A Phase I Placebo-Controlled, Double-Blind Crossover Study to Assess Psychological Effects of MDMA when Administered to Healthy Volunteers,” also referred to as our MDMA/PTSD therapist training protocol.

Through extensive discussions and cooperation with the FDA, the protocol meets two goals at once. On the one hand, it is designed as a Phase 1 randomized, placebo-controlled, double-blind study of the psychological effects of MDMA on healthy volunteers. On the other hand, enrollment is limited to subjects who are participating in our MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) therapist training program. The final draft of the protocol meets both the FDAs goals and MAPS goals. Now that we have the FDAs “may proceed” letter, we will be seeking approval from an Institutional Review Board (IRB).

We will be measuring the psychological effects of MDMA on “healthy normals”  as contrasted with our international series of Phase 2 pilot studies evaluating MDMA-assisted psychotherapy in people who have treatment-resistant posttraumatic stress disorder (PTSD). We will employ some psychological measures that have not yet been used in an MDMA research project as well as some that we have used before. The psychological measures include measuring mood with the Profile of Mood States, personality with the Neuroticism-Extroversion-Openness (NEO) Inventory, interpersonal closeness with a nonverbal (visual analog) self-report measure, psychological symptoms with the Brief Symptom Inventory (BSI), and suicidality with the Columbia Suicide Severity Rating Scale (C-SSRS).  As a crossover study, subjects will get placebo on one occasion and MDMA on the other.

The FDAs “may proceed letter marks a major turning point for MAPS. We now have the ability to offer one full-dose MDMA-assisted psychotherapy session to therapists who are preparing to conduct Phase 2 and Phase 3 MDMA/PTSD studies for MAPS. During these studies we will be gathering information about the psychological dynamics of MDMA-assisted psychotherapy. We believe that this new protocol substantially increases the chances that we will successfully conduct the next step in our mission: a Phase 3 multi-site pilot study with 20-30 co-therapist teams.

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September 15, 2009

US MDMA/PTSD Pilot Study Manuscript Rejected by Journal

 

We learned a few weeks ago that the Archives of General Psychiatry rejected our manuscript about MAPS flagship U.S. MDMA/PTSD pilot study. While we are very disappointed that the paper was rejected, we knew that it would be a long shot since this is the leading journal in the field of psychiatry and it has a conservative reputation. While some of the reviewers comments were quite insightful, other comments about MDMAs safety and the study design were simply mistaken. We are in the process of taking the insightful comments into consideration and rewriting the paper for submission to a new journal. 

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September 14, 2009

Canadian MDMA/PTSD study: Application to Import MDMA Submitted

 

We are in the final stages of getting our Canadian MDMA/PTSD study up and running. At the beginning of this month, Colin Holyk from Kerrisdale Pharmacy went to the Royal Canadian Mounted Police (RCMP) to be fingerprinted and have a criminal records background check as part of the process to become licensed to import MDMA into Canada. He has now applied to Health Canada for the license. We do not know how long it will take Health Canada to process his application, but we hope it will not be more than a month. After the pharmacist receives his license to import, we will obtain a specific import and export permit to have the roughly 7 grams of MDMA shipped to Vancouver from Switzerland. MAPS clinical research team is currently preparing documents for a pre-initiation site visit to take place on Thursday October 22.

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September 2, 2009
  Globe and Mail "Landmark B.C. study lets trauma sufferers find relief with ecstasy" by Frances Bula.
MDMA/PTSD Research Reported in Canadian Globe and Mail

The popular British Columbian Globe and Mail newspaper ran an article about MAPS planned MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder (PTSD) study, to take place in Vancouver, BC. The article titled, "Landmark B.C. study lets trauma suffers find relief with ecstasy" was written by Frances Bula, who presented a concise overview of the study to Canadian readers. As a result of this article, Ingrid Pacey, M.D. the Principal Investigator of the study, received a deluge of media inquiries and even discussed the study on Canadian National TV.

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August 24, 2009

MAPS Executive Director Rick Doblin Meets with Israeli MDMA/PTSD Team

 

On August 12, 2009, MAPS Executive Director Rick Doblin, Ph.D. met with Moshe Kotler, M.D., Principal Investigator of our Israeli MDMA/PTSD study. The two of them discussed the progress of the study and other administrative matters.

On August 24, Rick met with lead psychiatrist Sergio Marchevsky, M.D., and co-therapist Tali Nachoni, M.D. of the MAPS-sponsored Israeli MDMA/PTSD research team. They discussed the status of the fourth subject being treated in the study. Sergio reported to Rick that he felt more comfortable conducting MDMA-assisted psychotherapy after the therapist training seminar that took place in Austria this past June. Rick and Sergio further discussed plans to accelerate enrollment of subjects into the study, which is designed for 12 subjects. 

While meeting with Sergio, Rick noticed a poster on the wall announcing an international scientific conference on PTSD to take place in Jerusalem in late October. Rick and MAPS lead researcher Michael Mithoefer, M.D., are now planning to attend that conference, at which Michael will present a poster about the results of our US MDMA/PTSD study.

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August 13, 2009

New Hospital Found for Jordanian MDMA/PTSD Study

MAPS Executive Director Rick Doblin Ph.D. visited Amman, Jordan to further explore MAPS planned Jordanian MDMA/PTSD study. Principal Investigator Dr. Nasser Shuriquie, who had been working for the Royal Jordanian Medical Services at the Jordanian Military Hospital in Amman, has taken a new position as the medical director of Al-Rashid Hospital, the first and largest psychiatric hospital in Jordan. Rick visited with Nasser at Al-Rashid and met with the hospital administrator Dr. Rifat Dadawi Al-Masri.  After discussions and a tour of the facilities, Rick concluded that Al-Rashid Hospital would be an excellent place to conduct our study.

While in Jordan, Rick was introduced by Nasser to representatives of Clinquest JO, a clinical research organization that assists pharmaceutical companies with conducting clinical studies in accordance with Jordanian and international standards of clinical research. The representatives are General Manager Maha Tutunji, M.D. and Managing Director Kamilla Novak, M.D. It is likely that MAPS will hire Clinquest to conduct data and study monitoring and manage Jordanian regulatory affairs. This will make conducting the study in Jordan more economical and convenient. The next steps for the Jordanian study are to finalize the protocol design elements for budgeting and submission to regulatory authorities in Jordan. 

MAPS lead researcher Michael Mithoefer M.D. and Rick are planning a visit to Jordan on October 20, to speak to Nasser and associates about the results of our US study and our treatment method. This visit is timed so Michael and Rick can also attend an international scientific conference on PTSD taking place in Israel.

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August 12, 2009

Second Productive Teleconference with the U.S. FDA about MDMA Therapist Training Protocol

MAPS Researchers Michael Mithoefer, M.D., Ilsa Jerome, Ph.D., Amy Emerson, Valerie Mojeiko, and Rick Doblin Ph.D. had a second teleconference about our MDMA-therapist training protocol with officials in the FDAs Division of Psychiatric Products. The FDA requested that we add additional psychiatric measures for pre-and post-MDMA administration and that we design the study with a double-blind, placebo-controlled methodology. The alterations to the protocol will more rigorously examine the psychological effects of MDMA on healthy volunteers. We will be permitted to limit subjects to the therapists in our training program who will conduct Phase 2 and Phase 3 MDMA/PTSD studies. Our research team is in the process of modifying the protocol according to the FDAs requests and will be submitting a new version within the next week. We expect to obtain approval from FDA upon our next submission and will then submit the protocol to our Institutional Review Board.

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August 10, 2009
  Miller-Mccune "The Ecstasy and the Agony" by Matt Palmquist.

Matt Palmquist, writer for Miller-Mccune, published an article titled, The Ecstasy and the Agony, featuring interviews with Norwegian scientists Pl-rjan Johansen and Teri Krebs. They discuss their paper, "How could MDMA help anxiety disorders? A neurobiological rationale," published in the Journal of Pharmacology.

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June 22, 2009

Therapist Training Protocol Submitted to FDA

We submitted to FDA a protocol that would allow therapist from our MDMA/PTSD research teams to take MDMA in a clinical-therapeutic setting. We believe that it will benefit therapist who will be working with patients undergoing difficult emotional therapy to have a subjective understanding of an MDMA experience. The only way such an experience can be legally obtained is through FDA approval of a protocol for that purpose.

There is a precedent for our current protocol from the 1970s. Dr. Stanislav Grofs team at Spring Grove Hospital had FDA permission to administer LSD to mental health professionals involved in LSD research. Over 100 medical professionals received LSD in those training sessions, including doctors, therapists, counselors, nurses and attendants. These LSD sessions helped the mental health workers apply a therapeutic approach to patients undergoing LSD psychotherapy and when consulting with patients who had had LSD experiences. We submitted letters from two participants of that program to FDA, including one from John Hopkins researcher William Richards, PhD.

Protocol: MDMA Administration in a Therapeutic Setting in People Who Have Completed the MAPS Training Program for Therapists Learning to Conduct MDMA-Assisted Psychotherapy Research in Subjects with PTSD

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May 13, 2009

Canadian Study Awaits MDMA Import License

 

IRB Services, the Canadian IRB that we are working with, has approved the changes to our MDMA/PTSD protocol that were made by Health Canada. MAPS Canadian MDMA-assisted psychotherapy PTSD study is now at the stage of seeking to import the research-grade MDMA into Canada. MDMA has never been legally imported to Canada before, so the process is a little slow. MAPS is working with a pharmacist who has applied for the license to import and we hope the approval will take place swiftly but we have no idea how long this process will actually take.  When the license to import has been obtained, we can go forward with obtaining the specific import/export permits to ship the MDMA from the manufacturer in Switzerland to the pharmacist in Canada. Once the MDMA arrives in Canada, we can start enrolling subjects.

On Friday May 8, Valerie Mojeiko and Josh Sonstroem of MAPS Clinical Research Team, went to Vancouver to conduct a pre-study site visit. They met with co-therapists Ingrid Pacey, MD and Andrew Feldmar, PhD along with other site staff. This visit was necessary to ensure that data will be collected in manners compliant with FDA and Health Canada guidelines and that procedures will follow the protocol and IRB rules.

We are seeking a research assistant to help with this study 10-20 hours per week who lives in Vancouver and has prior research experience. Please view our job posting for more information.

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May 13, 2009

MDMA Data Analysis Nearly Ready for FDA Submission

 

On May 29, 2009, we will submit a preliminary dataset to FDA containing basic safety information from our US MDMA-assisted psychotherapy pilot study. Over the past several months MAPS Clinical Research Associate Valerie Mojeiko has been working diligently with a team of consultants from the pharmaceutical industry to prepare this preliminary data set, and to develop a streamlined collection of standard operating procedures to use in future data sets. This submission to FDA is the first of several data reports from our first pilot study and will provide the scientific justification for future protocols that we will submit to FDA.

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May 13, 2009

MDMA/PTSD Paper Completed and Sent for Friendly Review

 

MAPS is pleased to share that after months of work, our research team has completed a scientific paper that reports the remarkable results from our US MDMA/PTSD pilot study. Dr Michael Mithoefer, Annie Mithoefer, BSN, Ilsa Jerome, PhD, Mark Wagner, PhD, and MAPS President Rick Doblin, PhD, with assistance from statistician Yvonne Michel PhD, spent tremendous effort preparing the paper for submission to a peer-reviewed journal. We have now sent out the paper to several friendly reviewers for informal critique. We will incorporate the feedback we get from these reviewers and then submit the paper to a peer-reviewed scientific journal. This is a major milestone for MAPS and the legitimacy of psychedelic psychotherapy. When the paper is published in a peer-reviewed journal, MDMA-assisted psychotherapy will gain credibility among the scientific community and subsequently the general population. We have not yet released the paper to our readership, but keep checking back on our monthly email update to read about the results of this historic study.

 

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April 16, 2009

MAPS-Sponsored MDMA/PTSD Co-Therapists will Travel to MAPS Training Seminar in Austria, June 25 July 1, 2009:

 

MAPS has finalized plans and chosen a time and location for our first five-day MDMA/PTSD therapist training retreat for MAPS-sponsored researchers. The event will take place at the end of June in the Austrian mountains, where its off-season, reasonably priced, and more-or-less centrally located for therapist teams and MAPS staff coming together from the US, Canada, Switzerland, Spain, Israel, and Jordan.

Michael Mithoefer, MD and Annie Mithoefer, BSN, the co-therapist team from MAPS successfully completed U.S. MDMA/PTSD pilot study, will share techniques and results with the other therapists. June May Ruse, PhD, will present the principles in our treatment manual, which she is developing with feedback from our research teams.

The therapeutic outcomes in our US study were remarkable. In order to increase the chances that other co-therapist teams can replicate these results in MAPS other studies, Michael and Annie will present videotapes of their sessions and lead discussions about lessons theyve learned. The Swiss and Israeli co-therapist teams, who have treated some subjects but havent completed their studies yet, will also lead presentations about their results and methods. We will also discuss cultural differences, research methodology, and other treatments for PTSD and their similarities and differences from MDMA-assisted psychotherapy. We will have time for a breathwork session and opportunities for informal sharing. MAPS staff will be creating podcasts and writing blogs from the training seminar to keep our members and other interested parties informed of the valuable information that comes from it. 

This private retreat will also serve to inform MAPS 2010 conference, which is open to medical professionals, MAPS members and the general public. If you are interested in learning more about MDMA/PTSD therapy, please write to .(JavaScript must be enabled to view this email address) and she will put you on a list to receive information about future training opportunities.

This therapist training program, the first of its kind, will cost about $20,000. Were currently looking for one or more donors willing to underwrite this historic gathering.

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April 16, 2009

Canadian MDMA/PTSD Study Gets Green Light from Health Canada:

On March 17, Health Canada issued a No Objection Letter  for MAPS’ Canadian MDMA/PTSD study. This means that the Canadian protocol and the MDMA that will be used in that study (from Switzerland) have been completely approved by Health Canada. On April 2, Dr. Ingrid Pacey applied for her Section 56 exemption, equivalent to a DEA Schedule 1 license. This license will permit her to possess and handle MDMA for the study. Once she has obtained her Section 56 Exemption, probably within the next month, MAPS can proceed to acquire the necessary import/export permits for shipment of the MDMA from Switzerland to Canada. MAPS monitoring team has scheduled their first pre-study visit to discuss logistics with the team on May 9. If all goes smoothly, we anticipate starting the study within the next 2-3 months. 

This study is budgeted at $250,000, all of which remains to be raised.

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April 16, 2009

Research Monitoring Team Completes Visits Around the World:

 

Over the past several weeks, MAPS clinical research team members Valerie Mojeiko, Director of Operations and Clinical Research Associate, and Joshua Sonstroem, Information and Technology Specialist and Accountant, visited MAPS research sites around the globe. Visits such as these are conducted periodically to ensure that each research team is conducting their research in accordance with US Food and Drug Administration (FDA) guidelines so that the data can ultimately be presented to the FDA as well as to national regulatory agencies and the European Medicines Agency (EMEA).

Valerie and Josh made visits to our Swiss LSD/end-of-life anxiety study and Swiss MDMA/PTSD study. Rick Doblin, PhD joined Valerie and Josh at our Israeli MDMA/PTSD study, and at our proposed Jordanian MDMA/PTSD Study. 

The Israeli study is budgeted at $90,000, $60,000 remains to be raised.

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April 13, 2009

Harvard MDMA-Cancer/Anxiety Study Update:

A study that originated with MAPS, but that is now funded and managed independent of MAPS has had several important updates. The project offers MDMA-assisted psychotherapy and non-drug psychotherapy for advanced-stage cancer patients who are experiencing anxiety and other end-of-life issues not adequately treated by traditional means. The study had only been able to recruit from patients of the oncology service at the Lahey Clinic of Burlington, MA. Study candidates now just need to reside within a 100-mile radius of Boston and have an oncologist that the researchers can also work with. Moreover, the study now has a "Stage 2," so that 100% of participants have the opportunity to be part of the experiment employing the dose range of MDMA being evaluated as a treatment-level dose. To learn more about this study, either if you are curious or if you or someone you know may be interested in volunteering, see: http://clinicaltrials.partners.org/trials.aspx?tId=2284

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April 10, 2009

Threshold Foundation Donates $8400, SAePT Donates 5000 to MDMA/PTSD Research:

Ashawna Hailey, on MAPS’ Board of Directors, presented information about our MDMA/PTSD research to a Threshold Foundation meeting. The Threshold Foundation is a group of philanthropists who meet together to pool resources and discuss their charitable giving. Ashawna made a presentation that highlighted our MDMA/PTSD research as a tool to help treat veterans of war. We wish to thank Ashawna for her speech and we extend our gratitude to the members of Threshold Foundation for their $8400 donation.

At their annual meeting on April 3, the Swiss Association for Psycholytic Therapy (SAePT) voted to donate 5000 Euros to the Swiss MDMA/PTSD study being conducted by Dr. Peter Oehen. We’re grateful for this contribution and the international collaboration between MAPS and SAePT, whose members include both Dr. Oehen and Dr. Gasser.

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April 9, 2009

MAPS sent a payment of $20,000 to our Swiss MDMA/PTSD study, conducted by Principal Investigator Peter Oehen, MD, and his co-therapist Verena Widmer, RN. The study has enrolled 10 subjects, with 2 subjects still in the treatment process and two more to be enrolled. 

The study will cost $225,000; $60,000 is still needed.

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March 7, 2009

MAPS Clinical research team members Valerie Mojeiko and Joshua Sonstroem are currently out “in the field” meeting with MAPS researchers around the world on a several week- monitoring trip. Valerie currently writes from Switzerland where they have just finished a visit with our MDMA/PTSD therapy site under the direction of psychiatrist Peter Oehen, MD and are currently working with psychiatrist Peter Gasser, MD at our LSD/end-of-life anxiety study. 

  “I am amazed at how many regulations there are and how difficult it is to conduct this type of research accordingly,” said Valerie, “Only with careful attention to detail are we able to succeed in keeping up with the regulations—the researchers in Switzerland have put much effort into this endeavor.” These visits to the research sites not only keep our research compliant with International Council on Harmonization/Good Clinical Practice (international ethical and scientific quality standard for pharmaceutical research) (ICH/GCP) guidelines, but also serve as a way to communicate between research teams and identify training or resource needs and other opportunities. “It is great to see the data firsthand and to hear stories from the researchers of the people who were helped by this therapy—Im glad to be a part of this research,” said Valerie. 

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March 6, 2009

MAPS US MDMA/PTSD researchers, including Michael Mithoefer MD, Annie Mithoefer BSN, Mark Wagner PhD, Ilsa Jerome PhD, and Rick Doblin PhD, are preparing a paper about our U.S. pilot study of MDMA-assisted psychotherapy for the treatment of posttraumatic stress disorder, which has obtained impressive results The first draft of the paper is close to being sent out to friendly reviewers for initial scrutiny. We will submit the paper to a scientific journal after we respond to the critiques from colleagues and experts. The team is working diligently on the paper to ensure that we provide the eventual reviewers with a compelling submission. MAPS is very excited about the paper; now that we have run the data analysis our research results are really impressive.

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February 6, 2009

MDMA-Assisted Psychotherapy Helps Israeli Subject with PTSD from the 1967 Six-Day War:

 

MAPS President Rick Doblin PhD is delighted to share the success of a recent MDMA-assisted psychotherapy session in Israel. Rick was told a remarkable story during a check-in with the therapy team that is conducting our Israeli MDMA-assisted psychotherapy for the treatment of Posttraumatic Stress Disorder (PTSD) study.

Several weeks ago, the Israeli therapists successfully treated a patient who had suffered from PTSD for over 40 years, since the Six-Day War in 1967.  On his second MDMA session, the gentleman became acutely aware of fears he was still harboring within him since the war. He requested to leave the treatment room for a walk outside on the hospital grounds. The therapists escorted him outside as he had a breakthrough catharsis leading to dramatic healing. Ironically, planes were flying overhead on the way to bomb Gaza. 

With so much new trauma being created, it may seem underwhelming to speak of treating only 12 subjects each in our Israeli and proposed Jordanian studies. Yet if successful, these pilot projects will lead to larger-scale studies. Furthermore, as Charles Mackay, author of Extraordinary Popular Delusions and the Madness of Crowds (published in 1841), observed, “Men, it has been well said, think in herds; it will be seen that they go mad in herds, while they only recover their senses slowly, and one by one.” 

The MAPS team is honored and humbled to help someone who has suffered for so long. We hope that in the near future MDMA-assisted psychotherapy will be available legally to all who suffer from PTSD. We believe that in the future, our successes in the laboratory will translate into a more peaceful world.

Rick shared, “in the midst of war, we are developing the technologies of peace and healing.” 

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February 3, 2009

Health Canada Approves MDMA/PTSD Protocol Design:

 

On January 16, Health Canada first responded to our Canadian MDMA/PTSD protocol design. They accepted almost all elements of the protocol but had some items they wanted changed. We also asked for a change in the kind of previous treatments for PTSD the subjects will be required to have tried and failed.

On January 20, we submitted our replies, accepting some changes and making our best argument for why it was important to include people who were free from substance abuse histories for the last 6 months rather than for the last 12 months, as Health Canada had suggested. In addition, we asked to be able to include subjects who failed on other psychotherapy and either tried and failed, or refused medication. Health Canada had suggested including only subjects who had failed on other psychotherapy, and had tried and failed to obtain relief from medication - excluding subjects who refused to try medication.

On February 3, we heard from Health Canada that our responses had been accepted and that our protocol design had been fully approved (Hooray!). This shows yet again that it is possible to negotiate with regulatory agencies that put science first.

On January 12, we heard from Health Canada’s chemistry reviewers. We’ve been gathering our replies ever since, which included obtaining a new analysis of the heavy metals and residue on ignition of the MDMA.  In addition, Health Canada had a series of questions about the capsules, the lactose filler, and the bottles in which the capsules will be stored. 

On February 2, Professor Rudolph Brenneisen from Switzerland provided MAPS with documents regarding the chemical make-up of the MDMA that will be imported to Canada from Switzerland. Ironically, the last bit of information we need to gather is the batch number of the lactose! 

We expect to submit the required chemistry information in the next few days. Once the protocol is approved, we can start the process of obtaining the import/export permits for the MDMA from Switzerland, and can then start the study itself.

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January 20, 2009

Flagship US MDMA/PTSD Study Final Monitoring Visit:

 

On January 20-22, MAPS’ clinical research monitoring team, Valerie Mojeiko and Josh Sonstroem, went to Charleston, South Carolina to conduct a closeout visit for MAPS’ flagship US MDMA/PTSD study. The data from this study is now ready to be submitted to FDA. 

With this ending also comes the beginning of the “long-term follow up” extension to this study. During this extension, subjects who were enrolled in the original study will be retested on primary outcome variables one year or more after completion.  In the initial study, the last measurement of PTSD severity was taken two months after the last experimental session. Since this study took over four years to conduct, some of the data from the long-term follow-up will be from subjects who were treated over four years ago. The value of the long-term follow-up study will be substantially enhanced as a result of the extra length of time since treatment for most of the subjects. MAPS is pleased to have the help of volunteers Scott Martin MD and Mili Ballard to coordinate this long-term follow-up study.

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January 2, 2009

MAPS’ International MDMA/PTSD Research Progresses into the New Year.

 

Our Swiss and Israeli MDMA/PTSD studies are continuing to recruit subjects. Our Swiss study has only a few subjects still to recruit while our Israeli study has more than half remaining to be recruited. Sadly, the current war in Israel is creating many more people with PTSD.

For our proposed Jordanian MDMA/PTSD study, we’re in the process of having our informed consent form translated into Arabic for review by the Jordanian IRB. We’re also making progress toward obtaining the necessary insurance to conduct a study in Jordan. 

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December 19, 2008

The audio version of The Economist article about MAPS’ Flagship MDMA/PTSD study is now available in MP3 format.

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December 18, 2008

MDMA/PTSD Documents Submitted to Health Canada.

On December 18, all the documents for our Canadian study of MDMA-assisted psychotherapy in the treatment of people with Posttraumatic Stress Disorder (PTSD) were submitted to Health Canada (Canada’s version of the FDA). We’ve already obtained approval of our protocol and informed consent from a Canadian Institutional Review Board. We should receive a reply from Health Canada within 30 days of our submission. 

This is going to be a study with 12 subjects, similar in design to the recently completed US MDMA/PTSD study. Our main purpose for this particular study is to see if we can replicate the results of the US study. The budget for this study is $250,000, all of which remains to be raised.

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December 10, 2008

MAPS Releases Year-End MDMA Literature Review: As part of our ongoing clinical research responsibilities, MAPS reviews all of the MDMA- related articles published in scientific peer-reviewed journals to determine whether we need to modify our risk/benefit analysis for our clinical studies. We have now completed our review of the scientific literature published between December 2007 and November 2008 and submitted the review to the Institutional Review Board (IRB) that oversees our US MDMA/PTSD study. Nothing in the review changes our risk/benefit analysis regarding our research in human subjects. This review—along with all previous reviews—are compiled by MAPS Research Specialist Ilsa Jerome, and are posted on the MAPS website at: www.maps.org/mdma/protocol/litreview.html

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December 3, 2008

Newly Revised MDMA/PTSD Treatment Manual Now Online:
MAPS Researchers Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, have created a revised version of MAPS MDMA/PTSD treatment manual. The new version of the manual builds on a previous manual from 2005, and includes lessons learned from our recently completed US MDMA/PTSD pilot study. The team of researchers reviewed many hours of videotapes of the therapy sessions with the aim of finding clear examples of the key elements of the therapeutic method. The manual will be continually revised as we identify best practices and gather data to link methods to outcomes. The manual, will also be used to develop measurement tools for identifying key elements of the therapeutic method. 

The treatment manual, selected excerpts of the videotapes, and the measurement scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan. 

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December 2, 2008

A family foundation that wishes to remain anonymous donated $50,000 to MAPS for our US MDMA/PTSD research. The foundation had generously supported our US MDMA/PTSD study during the early stages of the research – giving substantial donations that played a crucial role in launching this project.

In addition, long-time MAPS supporter Tim Butcher (profiled in MAPS Bulletin article), is donating $17,000 to our US MDMA/PTSD study, with an initial donation of $5000 and $1,000 a month for the next year.

MAPS Researcher Michael Mithoefer, MD expressed his appreciation to these donors and noted, “Because MDMA can’t be patented these studies are not going to be funded by for-profit pharmaceutical companies. So far we have not been able to get government funding, and I don’t expect that to change in the foreseeable future. Contributions like yours are making it possible for us to complete the analysis and dissemination of our results and to now move forward with development of a training program, new protocols and teams of therapists and other researchers to perform a multi-center study. We are continually encouraged and deeply touched by the level of support MAPS is receiving for this work. The fact that this research can be accomplished by a small non-profit organization supported by a community of people who recognize the healing potential of MDMA and the importance of rational government policy based on science is quite extraordinary. This effort has already made a huge difference in the lives of the people with severe PTSD who participated in the study. I especially want to communicate that fact to you because you are playing a significant role in making it possible.” 

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November 11, 2008

MDMA/PTSD Study With War Veterans In The Planning Stage: 
 
  The European Medicines Agency has recently issued guidelines for sponsors interested in developing drugs to treat PTSD. The PTSD guidelines suggest that research be conducted in subgroups of people with PTSD, grouped according to the cause of their PTSD, for example, sexual assault or war-related PTSD. The purpose of such research is to identify if PTSD that is caused by a different type of trauma (i.e. sexual assault, war) responds to a specific treatment with similar or different success rates. If the treatment appears to have similar efficacy across subgroups, then people with PTSD from different causes can be enrolled in the same Phase 3 study but if the treatment is different, the Phase 3 studies should each be in a homogenous group of subjects by cause of PTSD. 
 
  As a result of the EMEA guidelines, MAPS, Michael Mithoefer MD, and Annie Mithoefer BSN will soon start the design and approval process for a new study investigating subjects whose PTSD is a result of war trauma. This study will include seven veterans, four women and three men, so that we can also gather some preliminary information on possible gender differences in response to MDMA-assisted psychotherapy. 

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November 7, 2008

Canadian IRB Gives Conditional Approval To MDMA/PTSD Protocol: 

On Friday, November 7 the Canadian Institutional Review Board (IRB) granted conditional approval for our MDMA/PTSD protocol. The conditions are relatively easy to meet. We must have resuscitation equipment at the research clinic, confirm that study staff will possess previous practical experience with psychological distress, especially with respect to psychedelic drugs, and add a tool for the assessment of subjects’ suicidal risk (e.g., suicidal ideation) to provide a more structured evaluation. We are now selecting a preferred measure for assessing suicide risk. We are also now preparing documents to be submitted to Health Canada (Canada’s version of the FDA).
 
  The IRB met on Wednesday, November 5 to review our replies to changes previously requested by the IRB. The IRB reviewed our responses and approved them. We replied to issues related to the open label stage of the protocol, the age of enrollment, and prior substance abuse history of subjects. The IRB agreed that we can retain the open label stage 2 portion of the protocol—the portion of the protocol in which everyone who was randomized to placebo in Stage 1 receives open label MDMA in the Stage 2. The inclusion of an open-label Stage 2 in our protocol has multiple purposes: 1) The therapist can better learn the contribution that MDMA itself plays in MDMA-assisted psychotherapy by treating patients who initially received placebo (psychotherapy without a full dose of MDMA 2) It is scientifically valuable since subjects who receive placebo initially act as their own controls; 3) It helps with recruitment and retention of subjects, since subjects know that by participating in the study they will eventually get the opportunity to receive MDMA-assisted psychotherapy
 
  We reached a compromise agreement with the IRB on the age of enrollment and prior substance abuse history. Subjects must be 21 years old to enter the treatment and cannot have abused drugs during the six months leading up the treatment. We also shortened the length of the informed consent form, as requested. Our success with the Canadian IRB is an important milestone in our march toward the globalization of MDMA/PTSD research. 

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October 15, 2008

The fortieth edition Journal of Psychoactive Drugs published an article “MDMA-Assisted Psychotherapy Using Low Doses in a Small Sample of Women with Chronic Posttraumatic Stress Disorder” by José Carlos Bouso PhD candidate, Rick Doblin PhD, Magí Farré MD PhD, Miguel Ángel Alcázar PhD, and Gregorio Gómez-Jarabo PhD. This article reports on the MAPS-sponsored MDMA-assisted psychotherapy study in Spain that was prematurely shut down by the Spanish government. The abstract of the article is as follows:

“The purpose of this study was to investigate the safety of different doses of MDMA-assisted psychotherapy administered in a psychotherapeutic setting to women with chronic PTSD secondary to a sexual assault, and also to obtain preliminary data regarding efficacy. Although this study was originally planned to include 29 subjects, political pressures led to the closing of the study before it could be finished, at which time only six subjects had been treated. Preliminary results from those six subjects are presented [in the article]. We found that low doses of MDMA (between 50 and 75 mg) were both psychologically and physiologically safe for all the subjects. Future studies in larger samples and using larger doses are needed in order to further clarify the safety and efficacy of MDMA in the clinical setting in subjects with PTSD.” 

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October 10, 2008

From October 6-10, 2008, Michael Mithoefer MD, Annie Mithoefer BSN, and June May Ruse PhD, worked on the MDMA/PTSD treatment manual. This was their second week working together in person, with a third week anticipated in December or January. They have reviewed many hours of videotapes of therapy sessions from Michael and Annie’s recently completed US MDMA/PTSD pilot study, with the aim of finding clear examples of the key elements of the therapeutic method. They intend to develop scales of approximately ten key elements of the therapeutic method. These scales would then be used by raters to evaluate researchers/therapists’ adherence to our specific therapeutic method.

The treatment manual, selected excerpts of the videotapes, and the scales of the key elements of our therapeutic method, will form the core of our therapist training program for the male/female co-therapist teams who will conduct MAPS’ Phase 3 multi-site studies. We anticipate sponsoring studies in 20-30 different locations across the US, Europe, Israel and Jordan. 

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October 7, 2008

On October 7, 2008, MAPS sent a draft of a protocol for a MAPS-sponsored MDMA/PSTD pilot study to Royal Jordanian Military psychiatrist Nasser Shuriquie. Dr Shuriquie needs to show the protocol to other medical officials to gauge whether there is sufficient support to justify submitting a final draft of the protocol to a Jordanian Ethics Committee and the Jordanian Ministry of Health. This version of our protocol differs from other pilot studies in several ways. It begins with a three-subject open label run-in in which both the subjects and the therapists know that MDMA is being administered. In this way, the therapist gets a chance to practice our therapeutic technique and become familiar with the therapeutic process before administering MDMA or placebo to other subjects in the context of a placebo-controlled, randomized, double-blind study. We believe that it is important for the therapist to get a chance to become comfortable with the procedure prior to starting a controlled study. The remainder of the protocol is a nine-person study, where six subjects receive three sessions of full-dose MDMA, 125 mg followed one-and-a-half to two-and-a-half hours later by 62.5 mg. Three subjects would receive active placebo, in this case 40 mg followed 1.5-2.5 hours later by 20 mg. Our Swiss, Israeli and Canadian MDMA/PTSD pilot studies are using 25 mg as the active placebo while our US study used an inactive placebo.

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September 17, 2008

On September 17, 2008, French psychiatrists Olivier Chambon and Fred Rosenfeld met with Patrick Lemoine MD in Lyon, France to discuss possibilities of starting a MAPS-sponsored MDMA/PTSD pilot study at a clinic where they work and that Dr. Lemoine directs. MAPS President Rick Doblin PhD and Director of Operations Valerie Mojeiko spoke in Paris in March 2008 at a conference about hallucinations in an attempt to catalyze MDMA/PTSD research [Link to article in current MAPS Bulletin on page 17]. On June, 28 2008, Valerie and Josh Sonstroem, MAPS’ Clinical Research Associates, conducted a site visit at the clinic where Drs. Chambon and Rosenfeld work. 

After meeting with Drs. Chambon and Rosenfeld, Dr. Lemoine was intrigued but raised some concerns about MDMA neurotoxicity and cardiotoxicity. We sent detailed scientific information about those risks and await news as to whether we can move to the next stage of the project, which would be to develop a protocol that would be submitted to an Ethics Committee and the French Ministry of Health

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September 16, 2008

The Institutional Review Board that is reviewing our Canadian MDMA/PTSD study sent us a letter dated September 16, 2008, requesting a few changes to the protocol we submitted (PDF) .  We were delighted to receive this letter since it is clear now that the study itself will be approved. The IRB has some issues of concern that need a further exchange of information before being resolved.

The issues of concern relate to the open-label stage 2 portion of the protocol, the age of enrollment, and prior substance-abuse history of subjects. In addition, the Canadian IRB stated that our informed consent form was too long and detailed for subjects to fully comprehend and needed to be significantly shortened. This is in stark contrast to our United States IRB, which wanted an exhaustive informed consent form. The US form was so long that we instituted a non-graded quiz at the end to make sure that the subjects understood the nature of the risks of MDMA-assisted psychotherapy and the key elements of the study design.

We are gathering letters of support for the Canadian protocol from various experts, and will respond soon to the IRB’s concerns. Once the IRB approves a final version of the protocol and informed consent, we will then submit it to Health Canada – Canada’s version of the FDA. We hope to have this study fully approved and ready to begin in early 2009.

The budget for this study is $150,000, all of which remains to be raised. 

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September 8, 2008

MAPS has just sent to a Canadian Institutional Review Board (IRB) a protocol for a randomized, active -placebo controlled, double-blind study of MDMA-assisted psychotherapy for people with PTSD to take place in Vancouver BC.

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July 6, 2008
  The Sunday Baltimore Sun "Tuning In, Not Out" by .

The Sunday Baltimore Sun published an editorial ("Tuning In, Not Out") supporting research into the therapeutic potential of psychedelics. The editorial mentions the MAPS-supported research into MDMA-assisted psychotherapy in people with PTSD and ends by stating, "Instead of banning drugs that are perceived as bad simply because of their recreational use, scientists should be encouraged to pursue legitimate study - lest we miss out on a valuable medicinal tool."

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May 4, 2008
  The Sunday Times "Ecstasy is the Key to Treating PTSD" by Amy Turner.

The Sunday Times (London) recently published "Ecstasy is the Key to Treating PTSD," an in-depth piece on MDMA-assisted psychotherapy in people with PTSD, focusing on Dr. Mithoefer's MAPS-supported study and featuring quotes from MAPS president Rick Doblin and British psychiatrist Ben Sessa.

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April 3, 2008

The list of articles and information on potential risks of MDMA now includes a report of estimated risk of MDMA in people with hepatitis C. While there is nothing in the medical literature on the topic, this report draws on information about MDMA, heptatitis C, and drugs used to treat it.

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February 6, 2008

This letter by Krebs and Johansen commenting on and questioning the findings of the prospective study of cognitive function in ecstasy users is now published in the Archives of General Psychiatry. The letter addresses issues relating to the nature of the test score differences, the existence of long-term retest effects, participant durg use history and effects of anxiety arising from stereotype threat.  Schilt and colleagues’ reply appears alongside the letter. They respond to questions concerning retest learning effects and re-analyze data with respect to drug use history. Krebs and Johansen are conducting an examination of psychological defense mechanisms in experimental sessions from Mithoefer’s randomized, placebo-controlled study of MDMA-assisted psychotherapy in people with PTSD.

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November 30, 2007
  Science Daily "Methamphetamine is not MDMA" .
An excellent article about studies on the effects of methamphetamine, not MDMA, describes findings in rats, not people.

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November 30, 2007

MDMA is not a type of methamphetamine: Despite its title, the recent Science Daily piece “Club Drugs Inflict Damage Similar To Traumatic Brain Injury” is about studies on the effects of methamphetamine, not MDMA, and describes findings in rats, not people. Read a brief commentary on this news report.

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November 29, 2007
  Journal of Psychopharmacology "MDMA, politics and medical research: Have we thrown the baby out with the bathwater?" by Ilsa Jerome.

Sessa and Nutt have recently published an editorial in the Journal of Psychopharmacology, "MDMA, politics and medical research: Have we thrown the baby out with the bathwater?", speaking out against the effects of politics and regulation on medical research with MDMA and in favor of more basic and medical research. In their editorial, Sessa and Nutt discuss the costs to the research enterprise imposed by regulation of MDMA, and proposes at least three avenues of further research. The piece is provocative and uneven, but makes for encouraging reading for supporters of MDMA psychotherapy research.

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November 25, 2007
  Washington Post "The Peace Drug" by Tom Shroder.

Washington Post magazine published an article (MAPS PDF Permalink) featured as the cover story about MAPS’ and Dr. Michael Mithoefer’s MDMA-PTSD research entitled "Peace Drug". This article is overall positive with one minor mistake--the idea of MDMA being prescribed only by specially trained therapists in psychedelic clinics is attributed to Dr. Michael Mithoefer when it should have been attributed to Rick Doblin Ph.D.’s dissertation. This article is unique as it is the first time that a reporter has been allowed to interview a research participant from this historic study. You can read the comments about this article here.

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October 12, 2007

MAPS communications director Jag Davies conducted a podcast interview (mp3) with Dr. Michael Mithoefer, in which Dr. Mithoefer discusses the details of his study, his working relationship with wife and co-therapist Annie Mithoefer, and his musings on the psychological mechanisms involved in MDMA-assisted psychotherapy.

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October 10, 2007

Sixteen out of twenty subjects have completed the double-blind protocol in Dr. Michael Mithoefer’s flagship MAPS-sponsored FDA Phase 2 study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD). Three new subjects have been enrolled, two of which are close to completion of the first stage of the protocol. One of these new subjects is a US military veteran whose trauma occurred during combat in Iraq.

  Last month, MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, also a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The FDA has accepted our request, which we have just submitted to our institutional review board (IRB) for final review.

 

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October 1, 2007
  American Medical News "Altered Perceptions: Good Outcomes from ‘Club Drugs’" by Victoria Stagg Elliot.

American Medical News published a feature article entitled "Altered Perceptions: Good Outcomes from 'Club Drugs'"? MAPS President Rick Doblin, PhD, and researchers Michael Mithoefer, MD, John Halpern, MD, and Charles Grob, MD, are quoted. American Medical News is a weekly newspaper for physicians published by the American Medical Association that is ciculated to over 230,000 physicians and health policy regulators.

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September 3, 2007

MAPS and Dr. Mithoefer submitted a protocol amendment to FDA, seeking approval to treat a 21st subject, a US veteran with PTSD from the Iraq War. We need FDA permission to deviate from our inclusion criteria that requires all PTSD subjects to be treatment-failures from both drug and non-drug treatments. The request to include a subject who is not a treatment-failure is due to the sad fact that this veteran, like several others with whom we have spoken, has been diagnosed with PTSD but has never been offered treatment by the military. We expect to hear from FDA in a few weeks. Michael Mithoefer, MD, and Annie Mithoefer, BSN, have enrolled 18 out of 20 subjects in their MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic PTSD.  Another two potential subjects are currently in the screening process. The completion of MAPS’ flagship FDA Phase 2 clinical research study is now in sight.

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July 10, 2007

No cause for alarm: Despite claims to the contrary, the recently published meta-analysis of studies of memory in ecstasy users does not demonstrate that memory is impaired even after a few doses of ecstasy. Here are our conclusions reached after reviewing the paper and correspondence with one of the study authors.

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June 27, 2007

Yesterday, June 26, the 17th subject out of 20 completed the first experimental session in Dr. Michael Mithoefer’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post traumatic stress disorder (PTSD). We are still actively seeking to enroll in the study at least two US veterans with PTSD from the Iraq or Afghanistan wars.

  This Phase II clinical study is the first-ever FDA-approved human study evaluating MDMA’s therapeutic applications. Efficacy data is extremely promising so far, making a strong case for continuing research into FDA Phase III studies.

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June 26, 2007
   "Commentary on News Coverage of Ecstasy User/Memory Meta-analysis" by Ilsa Jerome.

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June 26, 2007
  Breitbart.com "Dance drug Ecstasy ‘Affects Memory’" .

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June 26, 2007
  Reuters "Taking Ecstasy Once Can Damage Memory - Study" .

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June 26, 2007
  Times On Line "Even Low Ecstasy Use Harms Memory" by .

News coverage of a soon-to-be published research report in the journal Human Psychopharmacology vary in depth and accuracy, with some claiming "Even Low ecstasy use harms memory," or Taking Ecstasy Once can Damage Memory", while others provide more details suggesting that this is not the case. The research in question is a meta-analysis of previous research studies. Read initial comments and reflections on the news coverage and research report13.

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June 19, 2007

On June 3, MAPS-sponsored researchers Michael Mithoefer, MD, Annie Mithoefer, RN, Peter Oehen, MD, and Verena Widmer, RN, presented on MDMA-assisted psychotherapy research at the European Conference on Traumatic Stress in Croatia. Also present at the conference was Swiss researcher Dr. Franz Vollenweider, who is conducting a physiological study of the subjects in the Swiss MDMA/PTSD study, measuring markers for PTSD before and after treatment. MAPS’ MDMA/PTSD research now has preliminary data to share with PTSD researchers around the world.

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June 6, 2007

The Netherlands XTC Toxicity (NeXT) research team has published yet one more prospective report of ecstasy users and non-users. In contrast to their earlier efforts, this report on attention and memory claims to have found differences between the two groups, with non-users performing better on verbal memory tests. However, the report contains problems both with the analysis and interpretation of the data.

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May 16, 2007

The latest data from one of the first studies to compare people before and after they used ecstasy, part of the Netherlands XTC Toxicity (NeXT) research program, has just appeared in the second of two reports. Like the first findings reported from this study, the subsequent report also failed to find any indications that ecstasy in low doses impaired selective attention or working memory, and found no ecstasy-use related changes in brain activation either.

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May 15, 2007

We have learned that the data being generated from the Swiss and Israeli MAPS-sponsored studies will be accepted by the US FDA.

  Although these protocols do not need to be approved by the FDA to be conducted in their home countries (they have already been approved by their home country’s regulatory agency equivalent to FDA and by local ethics committees), FDA review and approval enables us to submit to FDA the data from these two studies as part of MAPS’ Investigational New Drug (IND) application for MDMA-assisted psychotherapy in the treatment of PTSD. The data from these studies will be used to help negotiate with FDA regarding the design of larger Phase 3 studies intended to gather data to determine whether or not MDMA meets the requirements necessary to be approved as a legal prescription medicine.

  To learn more about the MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war- and terrorism-related PTSD, the protocol is posted on the MAPS Web site.

  To learn more about the MAPS-sponsored MDMA/PTSD study in Switzerland, the protocol is also posted on the MAPS Web site.

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May 13, 2007

Dr. Michael and Annie Mithoefer, the co-therapists for MAPS’ landmark US MDMA/PTSD study, were in Norway recently attending a workshop by Dr. Edna Foa, an internationally-recognized expert in the treatment of PTSD. The workshop was organized by Pal-Orjan Johansen, a Ph.D. candidate at the Trondheim Psychotherapy Research Program, Department of Psychology, The Norwegian University of Science and Technology, and Teri Krebs, B.S., Program in Neuroscience, Boston University.

    While in Norway, Dr. Michael and Annie Mithoefer were also able to work with Pal and Teri, who are conducting a MAPS-sponsored study reviewing audio and video recordings and transcripts of subjects in the Mithoefer’s MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy.

  Dr. Michael and Annie Mithoefer were also able to discuss with Pal and Teri their MAPS-sponsored project using the internet to search for reports of people with Asperger’s (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available.

  Drs. Mithoefer, Peter Oehen and Franz Vollenweider, will be presenting their MDMA/PTSD work at the European Conference on Traumatic Stress in Croatia next month.

 

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May 9, 2007

The Second Prospective Study of Ecstasy Users: No Support for Changes in Brain Activity, Associative Memory or Selective Attention. By Ilsa Jerome, Ph.D.

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April 13, 2007

The MAPS-sponsored study in Israel evaluating MDMA-assisted psychotherapy for subjects with war-and terrorism-related posttraumatic stress disorder (PTSD) has full government approval and is now in the subject recruitment stage. The study will be conducted at Beer Yakhov Mental Health Center, near Tel Aviv, under the direction of Principal Investigator Moshe Kotler, M.D., former chief psychiatrist of the Israeli Defense Forces. The therapeutic team has been expanded and will now include Sergio Marchevsky, M.D., in addition to Rakefet Rodrigez, M.D., and Rael Strous, M.D. 

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March 20, 2007
  Time Magazine "Taking A Trip For Your Mental Health" by John Cloud.

Time Magazine's annual "What's Next" issue ran a brief story entitled "Taking a trip for your mental health," highlighting MAPS-sponsored MDMA, psilocybin, and ketamine research.

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March 17, 2007

An encouraging advancement is that we may be close to enrolling the final five subjects needed to complete Dr. Mithoefer’s study. We’ve focused more attention on recruitment with ads on various psychedelic-related websites and websites for PTSD support groups and currently have more than five subjects going through the screening process. Two of these potential subjects are Iraq War veterans. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies.

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March 11, 2007

After several years of effort, three rejections, and an appeal, the Institutional Review Board (IRB) for Dr. Michael Mithoefer’s flagship MAPS-sponsored US MDMA/PTSD study approved an amendment to the study’s protocol. The IRB decided that it will not object to subjects speaking with the media and/or documentary filmmakers following completion of each subject’s participation in the study. The IRB originally insisted that patients not speak with the media even after the entire study is complete. After years of careful consideration, the IRB has now determined that it has no jurisdiction to control subjects’ decisions about whether or not to speak to the media. Now that the media policy has been resolved, we are ready to move forward with our 12-month follow-up evaluations, which the IRB has previously approved.

 

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March 10, 2007

Dr. Peter Oehen’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy for subjects with chronic posttraumatic stress disorder (PTSD) has been making swift progress. Last Thursday, March 8, the second subject in Dr. Oehen’s study underwent the second experimental treatment session. The third subject will undergo the first experimental session later this week, and the fourth and 5th subjects have already been recruited.

 

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March 6, 2007
   "External Source" by .
Peter Jennings' special ABC report entitled Ecstasy Rising is available for viewing. This groundbreaking documentary discusses MDMA's cultural history, its use as a therapeutic tool, the government's criminalization and exaggeration of its risks, and MAPS' recent success with MDMA-assisted psychotherapy research. Regarding this clip we would like to give SPECIAL thanks to Nathan for ripping this footage and hosting it onsite Many gracious THANX...!

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February 28, 2007

MAPS has committed $5,300 to Dr. Franz Vollenweider at the Psychiatric University Hospital in Zurich to co-sponsor a secondary study that will gather data for physiological assessments of subjects in Dr. Oehen’s MDMA/PTSD study. The additional study will use several different measures to assess the psychophysiology of PTSD by using EEG/ERP and other biological measures such as heart rate variability (HRV) and pre-pulse inhibition (PPI). These parameters will be measured before and after the MDMA-assisted psychotherapy to allow researchers to evaluate changes in various areas of the brain and body. We expect that this additional neurophysiological and biological data will document the efficacy of MDMA-assisted psychotherapy. The amendment to Dr. Oehen’s protocol to include Dr. Vollenweider’s research was previously approved by Dr. Oehen’s Ethics Committee (IRB) in September 2006.

  For more on this study, see Dr. Oehen’s article in the Fall 2006 MAPS Bulletin.

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February 26, 2007
  Sky News (UK) "Ecstasy Trials Approved" .

The UK’s Sky News published a short article describing Dr. Peter Oehen’s MAPS -sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder (PTSD).

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February 14, 2007
  Swiss Radio International "“Ecstasy” Used to Treat Swiss Trauma Victims" by .

Swiss Radio International's Swissinfo published a brief original article describing Dr. Peter Oehen's ongoing MAPS-sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant post-traumatic stress disorder.

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February 9, 2007

The Data Safety Review Board (DSMB) for Dr. Michael Mithoefer’s MAPS-sponsored FDA Phase 2 pilot study evaluating MDMA-assisted psychotherapy for subjects with posttraumatic stress disorder (PTSD) met in late January for its final review, now that 15 out of 20 subjects have completed the experimental treatment. The DSMB recommended that the study continue without modification. Ironically, the DSMB’s only safety concern was that those subjects who received the placebo might see a substantial increase in PTSD symptoms after tapering off of psychiatric medications. The DSMB is comprised of an M.D., a Psy.D. and a Pharm.D. not otherwise involved in the study. Efficacy data at this stage is promising, so far making a strong case for continuing the research into FDA Phase 3 studies. We’re already looking beyond the next five subjects and the completion of this initial study, to future research protocols.

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January 23, 2007
  Slate "What a Long Strange Trip It’s Been - Ecstasy, The New Prescription Drug?" by Amanda Schaffer.

Slate published a positive description of MAPS' MDMA drug development efforts in a front page article entitled "What a Long, Strange Trip It's Been: Ecstasy, the New Prescription Drug?"

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January 12, 2007

MAPS has donated $3000 to Pal-Orjan Johansen and Terri Krebs for a project that will seek to use the internet to search for reports of people with Asperger’s (a form of high-functioning autism) who have found MDMA to be helpful in their learning to cope more effectively in social situations. If we do find at least a handful of such reports, this could become another area of research, if funding becomes available.

  MAPS also awarded another grant of $6000 to Pal-Orjan Johansen and Terri Krebs to expand their work reviewing transcripts of subjects in MAPS-sponsored MDMA/PTSD research, in order to code and compare the psychological defense mechanisms used in both non-drug therapy sessions and in the experimental MDMA-assisted therapy sessions. This study is designed to identify process variables that may help explain how MDMA can be a useful adjunct to psychotherapy.

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January 6, 2007

From January 3-6, 2007, MAPS’ clinical research team (Amy Emerson, Valerie Mojeiko, and Josh Sonstroem) was in Charleston, SC, conducting a monitoring inspection of Dr. Michael Mithoefer’s MAPS-sponsored IRB-, DEA-, and US FDA-approved MDMA/PTSD study. On January 5, the 15th subject participated in her third and final experimental MDMA-assisted psychotherapy session. On January 6, MAPS President Rick Doblin visited Charleston to meet with Dr. Michael and Annie Mithoefer and MAPS’ clinical research team to review the data, which looks very promising. An additional $125,000 will be required to complete this study.

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December 14, 2006
   "News Coverage of Dutch Prospective Ecstasy User Studies" by Ilsa Jerome.

In response to the sensationalistic and inaccurate recent news coverage of prospective Ecstasy user studies by Dutch researcher Dr. Maartje M. de Win, MAPS President Rick Doblin, Ph.D. wrote this open letter to Dr. de Win voicing his concerns, and MAPS Clinical Research Associate Ilsa Jerome, Ph.D., wrote a special report evaluating the media's claims and how they relate (or not) to the actual data.

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December 8, 2006
   "PDF File" by .

While in Thailand to testify in a medical MDMA trial, MAPS President Rick Doblin took the opportunity to do an interview with The Nation, Thailand's largest English-language daily newspaper. In the interview, Doblin speculates on the possibility of conducting MDMA/PTSD research with tsunami victims and discusses MAPS' international psychedelic research agenda.

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November 27, 2006
  Biology News Net "Ecstasy can harm the brains of first-time users" .

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November 24, 2006

Dr. Peter Oehen conducted the second experimental MDMA-assisted psychotherapy session with the second subject in his ongoing MAPS-sponsored MDMA-assisted therapy pilot study for subjects with treatment-resistant post-traumatic stress disorder (PTSD). According to Dr. Oehen, the subject delved into some challenging content, but the long-term results appear to be quite positive. “She was confronted very hard with anxiety, negative emotions related to the sexual abuse and especially her isolation and avoidance of closeness,” said Dr. Oehen. “It was hard work for her in the following days but since then she has made substantial progress”. Therapist reports confirm that the subject “confronted very hard with anxiety and with negative emotions related to their tramua - especially isolation and avoidance of closeness.” This was followed by “hard work for the subject during the following days but since then they have made substantial progress.”

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October 23, 2006

The MDMA arrived on-site today at Harvard’s McLean Hospital for Dr. John Halpern’s MAPS-initiated study evaluating MDMA-assisted psychotherapy for subjects with advanced-stage cancer suffering from end-of-life anxiety disorders. MAPS has withdrawn from direct sponsorship of this study, but will still have access to the data generated by Dr. Halpern, as will any other organization that requests it.

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October 22, 2006

The MAPS clinical research monitoring team arrives in Israel today for the Site Initiation visit for the MAPS-sponsored MDMA/PTSD pilot study at Beer Yakhov Mental Health Center in Tel Aviv, Israel, under the direction of Principal Investigator Moshe Kotler, former chief psychiatrist of the Israeli Defense Forces. The study will focus on individuals suffering from war-related PTSD.

  The MAPS clincial monitoring team consists of MAPS President Rick Doblin, Ph.D., Clinical Research Associate Valerie Mojeiko, and volunteer clinical research expert Amy Emerson. Their job is to help the researchers prepare the study to fit the strict guidelines necessary for the data generated to be eligible for consideration by the FDA and the European Medicines Agency.

  On October 25, Doblin and Lester Grinspoon, M.D., will join Israeli and Palestinian drug policy experts in Jerusalem to talk at the first Arab-Israeli Joint Conference on Peace and Drug Policy, sponsored by the Ale-Yarok (“Green-Leaf”) Party. The conference will focus on issues related to the cultural impacts of marijuana, its regulation, and its medical uses and research. While in Israel, MAPS staffers Rick Doblin and Valerie Mojeiko will also be conducting a “Psychedelic Emergency Services” training seminar for a team of volunteers organizing a rave near the Dead Sea.

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October 19, 2006

Principal Investigator Peter Oehen, M.D., officially initiated the Swiss MAPS-sponsored pilot study evaluating MDMA-assisted psychotherapy for subjects with treatment-resistant posttraumatic stress disorder (PTSD). Today, Dr. Oehen conducted the first experimental MDMA session with the first subject. Congratulations, Dr. Oehen!

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September 13, 2006

Dr. Michael Mithoefer treated the 13th subject with a third MDMA-assisted psychotherapy session today in his MAPS-sponsored FDA Phase II pilot study of MDMA-assisted psychotherapy for individuals with treatment-resistant post-traumatic stress disorder (PTSD). The 16th patient out of 20 was also just screened and admitted to the study earlier this week.

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September 12, 2006

Dr. Peter Oehen’s MAPS-sponsored MDMA/PTSD protocol has full government approval and the first subject began the screening process last week. The Ethics Committee (the Swiss IRB equivalent, which previously approved Dr. Oehen’s MDMA/PTSD protocol) met on September 7 to review an addendum to the protocol, and we just learned today, September 12, that the IRB has granted approval, meaning that the study can now officially be initiated! The addendum is for an associated study by Dr. Franz Vollenweider, University of Zurich, that will examine subjects before and after treatment with MDMA-assisted psychotherapy. Dr. Vollenweider is going to measure several physiological factors that have been associated with PTSD (startle response, heart rate reactivity) as well as various EEG parameters to see if the MDMA-assisted psychotherapy results in any changes in these measures. The first applicant for the study will be administered baseline CAPS and PDS tomorrow, and, now that we have full approval, we hope to report shortly that the first subject has been treated with MDMA-assisted psychotherapy.

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August 21, 2006

The Norwegian Research Council website recently posted “Ecstasy: Historien Starter” (article in PDF format) (English translation “Ecstasy; The History Begins”), an article by Pål-Ørjan Johansen that discusses the scheduling history, the research controversies, and new research into the therapeutic potential of MDMA.

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August 20, 2006
   "PDF File" by .
VG, one of the largest Norwegian newspapers, published a very positive piece on MDMA psychotherapy research that includes interviews with Charles Grob, M.D., and Pål-Ørjan Johansen, Ph.D. (View PDF of article).

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August 18, 2006
  The Guardian "Truth About Ecstacy’s Unlikely Trip from Lab to Dance Floor" by David Adam.

The Guardian reports on Merck's official history of MDMA, as recounted in a recently published paper in the journal Addiction.

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August 15, 2006
  Lancet Neurology "Hallucinogen Research Inspires Neurotheology" by Kelly Morris.

In their “Newsdesk” section, the journal Lancet Neurology published “Hallucinogen Research Inspires Neurotheology,” a report on developments in research with psychedelic compounds, such as ketamine or psilocybin. The piece contains comments from Roland Griffiths, John Halpern and Deborah Mash.

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August 5, 2006

The Israeli Import Permit and the Swiss Export Permit have now been approved. On Thursday, August 3rd, in the midst of war, about 5 grams of MDMA arrived in Israel for MAPS’ MDMA/PTSD study, imported into Israel from Switzerland. This study has full government approval and will be initiated in Fall 2006. 

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July 26, 2006
  Reuters "Taking Ecstasy Once Can Damage Memory - Study" .

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July 21, 2006

Dr. Michael and Annie Mithoefer treated the 13th subject with the second experimental MDMA/placebo session in their MAPS-sponsored MDMA/PTSD trial today. Dr. Mithoefer described it as “impressive.”

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June 21, 2006
  http://www.cpdd.org "College on Problems of Drug Dependence" by G. Jager, M. Win, J. van Ree, W. van den Brink, R. Kahn and N. Ramsey.

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June 17, 2006

Switzerland’s DEA equivalent, the BAG, has officially approved Dr. Peter Oehen’s MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for subjects suffering from treatment-resistant Posttraumatic Stress Disorder (PTSD). Permission from BAG was the final regulatory hurdle, since Dr. Oehen has already received approval from the Ethics Committee (Switzerland’s IRB equivalent) and SwissMedic (Switzerland’s FDA equivalent).

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June 16, 2006

Dr. Michael Mithoefer initiated the first experimental MDMA-assisted psychotherapy session with the 13th subject out of 20 in his MAPS-sponsored FDA Phase II pilot study. This subject was the first to receive supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA’s therapeutic effectiveness, a change recently approved by Dr. Mithoefer’s Istitutional Review Board (IRB), the Food and Drug Administration (FDA), and the Data Safety Monitoring Board (DSMB). The supplemental dose did not seem to intensify the already strongly therapeutic experience but it did prolong the period of maximum therapeutic effect for at least 90 minutes.  This appeared to be very useful. We were also happy to see that, as expected, there was no problem with vital signs.

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June 7, 2006

Switzerland’s FDA equivalent, SwissMedic, has now fully approved Dr. Peter Oehen’s MAPS-sponsored MDMA/PTSD study. The protocol design had already been approved, and earlier this week we received approval for the source of the MDMA itself, which MAPS is purchasing from a Swiss manufacturer. Now that Dr. Oehen has received permission from SwissMedic and an Ethics Committee (the Swiss IRB equivalent), the only regulatory hurdle remaining is licensing from BAG, the Swiss DEA equivalent, which is expected within a month. Initiation of Dr. Oehen’s study will take place shortly thereafter.

Approval from SwissMedic of the source of the MDMA for the Swiss MDMA/PTSD study will now enable MAPS to move forward with the export of MDMA from Switzerland to Israel. The import/export of the MDMA is the last regulatory step in the initiation of Dr. Moshe Kotler’s MAPS-sponsored MDMA/PTSD research at Beer Yaakov Mental Health Center in Tel Aviv, in subjects with war and terrorism-related PTSD.

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June 4, 2006

Dr. Michael Mithoefer has received Institutional Review Board (IRB) approval for several key changes that FDA had recently approved to his MAPS-sponsored study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. The changes include (1) adding a third experimental session to the two that are currently included in the protocol to test whether a third session adds significantly to the therapeutic process, (2) providing supplemental dosing of half the initial amount of MDMA administered 2 to 2.5 hours after the initial dose in order to prolong the plateau of MDMA’s therapeutic effectiveness, and (3) doing without an ER doctor on standby in the next room since Dr. Mithoefer has become a board-certified ER doctor as well as a board-certified psychiatrist.  Now that the Data Safety Monitoring Board (DSMB), FDA, and IRB have all approved these changes to our protocol, they will be implemented for the study’s remaining eight subjects.

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May 15, 2006
  The Boston Globe "A Good Death" by Scott Allen.

The Boston Globe published "A Good Death", an article that discussess the resurgence of interest in studying MDMA and psychedelic drugs to help people with cancer deal with anxiety and pain. The piece describes research MAPS helped design and locate funding for that will look at the potential therapeutic benefits of MDMA in people who are anxious as a result of advanced stage cancer. The latest MAPS Bulletin contains an article about the woman described in this article who used MDMA to treat cancer-related pain and anxiety. A PDF of the this piece is now available.

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April 14, 2006
  The Guardian "Lancet Calls for LSD in Labs" by James Randerson.

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April 14, 2006
  The Lancet "Reviving Research into Psychedelic Drugs" by .

A recently published editorial in the Lancet supports research into the potential therapeutic benefits of psychedelic drugs and calls for a new legal structure that makes this research easier and less burdensome to conduct. The Lancet editorial was likely inspired by a commentary published in the British Journal of Psychiatry. This editorial was then covered by the British newspaper, the Guardian.

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April 5, 2006

In some fantastic news, philanthropist Peter Lewis has agreed to donate $250,000 directly to Harvard Medical School-affiliated McLean Hospital to fund the costs of Dr. John Halpern’s study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer.

  Dr. Halpern’s MDMA/cancer anxiety study is already fully approved by the FDA, DEA, two Institutional Review Boards (IRB’s, at Lahey Clinic and McLean Hospital) and the Massachusetts Dept. of Public Health. Now that the study is fully funded, Dr. Halpern is preparing to initiate the study and hopes to enroll the first subject within the next several months.

As we reported in the last email update, MAPS has withdrawn from direct sponsorship of this study. The McLean Hospital administration felt that MAPS long-term advocacy for MDMA psychotherapy research and general opposition to Prohibition would cause the results of the study to be challenged as biased if MAPS were to sponsor the study and they did not want McLean Hospital to be involved in a study funded by MAPS. Therefore, we decided that it would be best for MAPS to offer to withdraw from further direct financial sponsorship of Dr. Halperns research so that the study, which many people labored so long to start, could proceed. Sacrifices sometimes need to be made. In this case, we decided that the benefits of the study moving forward substantially outweigh MAPS’ withdrawal from direct sponsorship. MAPS will still have access to the data generated by Dr. Halpern, as will any other organization that requests it.

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March 7, 2006

The DEA has, after over one year, issued a license for Dr. John Halpern’s study of MDMA-assisted psychotherapy in subjects with anxiety associated with advanced-stage cancer. The final regulatory approval has thus been obtained. Additional approvals have already been received from two Institutional Review Boards (IRB-McLean and Lahey Hospitals) as well as the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health.  MAPS has donated over $94,000 to McLean Hospital over the last five years in an effort to initiate the evaluation of MDMA-assisted psychotherapy. One fruit of this support has been Dr. Halpern’s $1.8 million grant from the National Institute on Drug Abuse (NIDA) for a methodologically state-of-the art study started with MAPS funding of the neurocognitive consequences of the use of Ecstasy. Now that the MDMA/cancer anxiety study is fully approved, MAPS is withdrawing from any further financial sponsorship. MAPS, independent of McLean and Dr. Halpern, still hopes to assist with seeking donors interested in now donating directly to McLean Hospital. We believe that this financial distance from MAPS, and more so the rigor of the methodological design of the study itself, will enable the results of the study to be viewed by skeptics as more objective. If the results of the pilot study are promising, MAPS will again explore options for the support of research at McLean Hospital.

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February 6, 2006

MAPS’ Data Safety Monitoring Board (DSMB) met to review records for the six new subjects who have enrolled since their last meeting in Dr. Michael Mithoefer’s study evaluating MDMA-assisted psychotherapy as a treatment for PTSD. With data from a total of eleven subjects before them, the DSMB reported that they did not have any concerns about the safety of the study, and recommended that it continue without modification. The DSMB is comprised of an M.D., a Psy.D., and a Pharm.D. not otherwise involved in the study. Dr. Mithoefer has successfully treated 11 out of an eventual 20 subjects, and is currently treating the twelfth.  The DSMB also reviewed and approved three protocol changes that Dr. Mithoefer and MAPS will initially submit to FDA and then, if approved, to our Institutional Review Board (IRB). Dr. Mithoefer is seeking permission to:  1) Increase the number of MDMA experimental sessions from two to three, to evaluate whether this extra session will enable subjects to make more therapeutic progress.  2) Administer supplemental doses of 1/2 the initial dose of MDMA 2 to 2 1/2 hours after the initial dose, in order to prolong the relatively short plateau of MDMA’s full therapeutic effectiveness.  3) Since Dr. Mithoefer has recently renewed his Board certification in ER medicine, we have asked to do without the additional Board-certified ER doctor sitting in the next room.  In comparison, Dr. Peter Oehen’s study in Switzerland has been designed and approved for three MDMA experimental sessions and the use of supplemental doses. Dr. Kotler’s study in Israel has been designed and approved with supplemental dosing but just two MDMA experimental sessions.

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January 25, 2006
  New Zealand Herald "Mental Scars of Iraq Conflict Participants Exposed" by Kim Sengupt.

Dear Editor,

The 25.01.06 article, "Mental scars of Iraq conflict participants exposed" by Kim Sengupta, reported that the US military was giving soldiers fighting the Iraq war "Ecstasy tablets to help free them of flashbacks and recurring nightmares," after the FDA "authorised the issuing of the MDMA drug to Iraq veterans after successful initial research carried out at a facility in South Carolina." This is not quite accurate. Its true that the initial MDMA research in South Carolina is generating very promising results, and the FDA did authorize the expansion of the research to include soldiers. However, no soldiers have yet been treated and the initial study has not been completed. Much larger studies will be needed before MDMA is ever a prescription medication. Research with MDMA for war and terrorism-related posttraumatic stress disorder (PTSD) has been approved in Israel and MDMA/PTSD research is soon to be approved in Switzerland. If approved as a treatment, MDMA will never be issued as tablets directly to soldiers or other patients. MDMA is not a standard pharmacological treatment. MDMA is intended to be used under direct supervision of a therapist as part of MDMA-assisted psychotherapy.

Rick Doblin, Ph.D.
President, MAPS (http://www.maps.org)
MAPS is the non-profit organization that is sponsoring
the research into MDMA-assisted psychotherapy

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January 25, 2006
  New Zealand Herald "Mental Scars of Iraq Conflict Participants Exposed" by Kim Sengupta.

An article in the New Zealand Herald about posttraumatic stress disorder (PTSD) in veterans mentions the use of MDMA for PTSD but makes some incorrect claimsA letter to the editor from Rick Doblin corrects the mistakes. This article demonstrates that there is a widely perceived need for more effective treatments for PTSD and that the MDMA research is increasingly accepted as a necessary and not very controversial effort.

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December 27, 2005
  Washington Post "A Political Debate On Stress Disorder" by Shankar Vedantam.

An article in the Washington Post, "A Political Debate On Stress Disorder," by Shankar Vedantam, reports that in 2004 the US Veterans Affairs Department spent $4.3 billion on PTSD benefit payments to a total of 215,871 veterans. If the results of the second half of our MDMA/PTSD study are as promising as the results of the first half, we will have data suggesting that it would be financially wise for the VA to fund the entire $5 million cost of MAPS' Phase III studies to evaluate whether MDMA-assisted psychotherapy for PTSD should become approved by the FDA as a legally-available treatment for PTSD.

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December 27, 2005

MAPS received word from Dr. Peter Oehen, Principal Investigator of the Swiss MDMA/PTSD pilot study cosponsored by MAPS and the Swiss Association for Psycholytic Therapy,  that the final written approval from the ethic committee arrived today. Dr. Oehen will now submit the protocol and the other documents to Swissmedic, for a review process that we expect will take a month or two. 

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December 20, 2005

Dr. Michael Mithoefer, Principal Investigator of the MAPS-sponsored MDMA/PTSD psychotherapy study in Charleston, South Carolina, filed an Annual Status Report with his Institutional Review Board (IRB). There have been no drug-related Serious Adverse Events (SAEs) and the results on treatment efficacy are promising.

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November 15, 2005
   "PDF Article" by .

An excellent roundtable discussion about psychedelics and Judaism was published in Jewish Currents, published by the Association for Promotion of Jewish Secularism, Inc. The article is entitled, "Just Say Maybe- Psychedelic Drugs, Healing and Politics: An Interview with Four Jewish Researchers (Rick Doblin, Charlie Grob, Julie Holland, Howard Lotsof).

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November 11, 2005
   "MP3 File" by .

The Good Drugs Guide Radio show, out of England, broadcast a show entitled,"The State of Ecstasy." The show is described as follows, "It's ten years since the death of Leah Betts, a teenager who died after taking a single tablet of ecstasy, also known as MDMA. Her tragic death triggered a huge backlash against the drug here in the UK. Even so, 700,000 people still take E every week in this country. So what have we learnt about ecstasy in the last decade? Do the stories of terrible comedowns, brains like swiss cheese, and instant death have any credibility? Could MDMA really become a prescription drug? And has the music got any better? We find out. Guests include Dr Julie Holland, author of Ecstasy The Complete Guide, Rick Doblin, president of www.maps.org, and Mike Linnell of drug charity Lifeline. The show also uses clips from the excellent ABC documentary, Ecstasy Rising."

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November 11, 2005

MAPS received word that the Israeli Ministry of Health has approved our MDMA/PTSD pilot study!! One condition was that the Israeli Anti-Drug Authority write a letter formally indicating support for the protocol, which the Israeli Anti-Drug Authority has done. Now we need to bring the Israeli therapeutic team to the US to observe an MDMA/PTSD session conducted by Dr. Michael and Annie Mithoefer and we need to bring MAPS Clinical Research Monitoring Team to Israel, to set up the Case Report Forms and the Standard Operating Procedures (SOPs). Plus we need to arrange to export MDMA to Israel for the study. Once these steps have all been accomplished, the study itself can begin enrolling subjects. We’re anticipating that the study can begin in March 2006.

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November 8, 2005

Dr. Michael Mithoefer received the disappointing news that the National Institute of Mental Health (NIMH) has rejected our grant application seeking $125,000 over two years for the development of a treatment manual for the use of MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder (PTSD).  MAPS’ grant application was not scored (it was considered in the bottom half of all applications). This rejection isn’t really surprising since the last time NIMH gave a grant for anything to do with psychedelic psychotherapy was over 30 years ago, with all NIMH intramural psychedelic psychotherapy research stopping in 1967. MAPS invested $2,768 in the NIMH grant application, but the money is not wasted. We have gained a better understanding of what it will take to complete the treatment manual that we have already begun to develop and we now can say that we have indeed tried to obtain funding from NIMH.  Maybe once we complete the initial pilot study, we can submit the results to NIMH and try again to obtain support. It has been reported that in 2004, the Veterans Affairs Department (VA) spent $4.3 billion on PTSD disability payments!  In 2006, the VA requested $2.2 billion for mental health services.  Once we have completed our initial pilot study, we may have a better chance of obtaining some federal funding for MDMA/PTSD research.

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November 7, 2005
  The Daily Texan "The Harm of Ecstacy, II" by Nishat Mukherji.

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November 7, 2005
   "Dear Editor,  I Was Disappointed to Read Misleading Information" .

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November 7, 2005
  The Daily Texan "Debunking Drug Folklore" by Ryan Ash and Elliott Ash.

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November 7, 2005
  The Daily Texan "The Harm of Ecstasy" by William Robins.

The Daily Texan, the newspaper of the University of Texas at Austin, published a letter about, "The harms of MDMA" that presented misleading information about MAPS' MDMA research projects. The letter critiqued a previous column entitled, "Debunking drug folklore," MAPS President Rick Doblin replied to correct the record. While taking time to write to a student newspaper may not at first glance represent a wise use of MAPS staff time, in the age of Google, even student letters can be read by a large number of people, especially when the topic is discussed repeatedly in the student newspaper. Indeed, the Daily Texan also published a more reasonable letter, "The harm of Ecstacy, II." While MAPS concentrates on scientific research, our educational mission is also of major importance.

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October 21, 2005
  Daily Bruin, UCLA "Activists Protest on Campus - Various Animal Rights Groups Rally Against Medical Testing on Primates" by Shauntel Lowe.

An article in the UCLA Daily Bruin discusses animal rights protesters objecting to a proposed study in primates, "Making Connections: MDMA Research on the Mechanisms of Affiliation and Trust." The article mentions that this research was submitted for funding to MAPS, by Anthropology Professor Alan Page Fiske, who is quoted as saying, "The biggest problems we have in the world are people not trusting each other and not feeling a solidarity (and) feeling distant," Fiske said. "If we could understand the basis of compassion and caring, that's about the most important thing human and biological sciences could do." A MAPS Bulletin article about Prof. Fiske's research can be found here. At present, there is no funding for the study.

Briefly stated, MAPS has not funded animal research for about ten years but is not categorically opposed to doing so if the research is of sufficient importance. MAPS considers Prof. Fiske's proposed research to be sufficiently important to be worthy of being conducted but the information it would generate isn't essential for MAPS' program of research intended to develop MDMA into an FDA-approved prescription medication. MAPS' top priority is our human studies into the therapeutic use of MDMA. These studies require substantial resources so our intention is to conduct further research in animals only when required by FDA.

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October 14, 2005

A DEA Field Investigator came to McLean Hospital to test the alarms on the safes at the Pharmacy, where the roughly 4 grams of MDMA will be stored for the MAPS-sponsored MDMA/cancer anxiety study. Everything seemed to be in order and the DEA investigator stated that his report should get processed within one month. We’re cautiously optimistic we’ll have the final approvals before the end of 2005.

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October 8, 2005

Dr.med. Peter Oehen submits an MDMA/PTSD protocol for review to a Swiss ethics committee, for a pilot study co-sponsored by MAPS and the Swiss Association for Psycholytic Therapy (SAePT). This study will involve three experimental sessions instead of two and will use supplemental dosing 2 1/2 hours after the initial dose.

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September 13, 2005
The following letter was addressed to Laura Huxley from the mother of a woman who died of cancer. Read about Laura Huxley's life with husband Aldous Huxley in her book This Timeless Moment.

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August 2, 2005
  News-Medical.net "Sotnikova et al. 2005 on MDMA and Parkinsons" .
Ironically, after NIDA-funded researchers Drs. McCann and Ricaurte claimed that MDMA damaged dopamine neurons and could cause Parkinson's disease, a claim that they later had to retract, new research conducted at Duke University Medical Center has shown that MDMA is the most effective of 60 drugs tested in reversing the symptoms of Parkinson's disease! This research was discussed in an article in News-Medical.Net; note also a brief commentary on this and other related research into MDMA as an anti-Parkinson's disease treatment.

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August 2, 2005
  MAPS "Comments on Sotnikova et al 2005" by Ilsa Jerome, Ph.D.

Read the original article