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Media > Newsletter: March 8, 2012



Ethics Board Approves Protocol
for Second U.S. Trial Site:
MAPS Email Newsletter
March 8, 2012

Dear MAPS Members and Friends,
MDMA/PTSD Research Worldwide

Welcome to the March 2012 edition of the Multidisciplinary Association for Psychedelic Studies (MAPS) Email Newsletter.

Imagine you could remove the emotional trauma from a tragic event in your life so that you didn't fear thinking about it again. What would it be like to have a fresh start? How would your relationships be transformed?

Just as MDMA-assisted psychotherapy can make it easier for people to process their past traumas, the data we're collecting in our international series of Phase 2 studies is making it easier for the broader culture to overcome our collective fear and suspicion, and to recognize that in the right contexts psychedelics can be powerful tools for healing and personal growth.

Here's just a sample of what's new this month:

  • The protocol for our new intern study of MDMA-assisted psychotherapy for PTSD was approved by the Institutional Review Board and awaits clearance from the FDA. The study will explore cheaper ways of administering treatment while helping train a new generation of therapists.
  • A paper describing the results of our recently completed Swiss study of MDMA-assisted psychotherapy for PTSD was submitted for publication in a scientific journal.
  • Our new observational study of ibogaine treatment for addiction was approved in New Zealand.
  • Researchers held a rousing debate about the promise and challenges of MDMA research at Breaking Convention: A Multidisciplinary Conference on Psychedelic Consciousness. The video and transcript are now available online.
  • DEA lawyers are having a difficult time responding to Prof. Lyle Craker's opening brief in his federal lawsuit against the agency for upholding the federal monopoly on marijuana for research.
Did you know that MAPS now has over 27,000 followers on Facebook, Twitter, YouTube, and Google+? Check us out on the social web and stay connected to the fast-growing psychedelic and medical marijuana research community.

With your continued support, MAPS is changing minds and healing culture by transforming psychedelics and marijuana into legitimate medicines.

Diligently,

Brad Burge
MAPS Director of Communications

    MDMA/PTSD Research:

  1. U.S. Intern Study: IRB Grants Conditional Approval, Protocol Submitted to FDA
  2. U.S. Relapse Study: First Subject Treated
  3. U.S. Veterans Study: Sixth Subject Treated, Protocol Amendments Accepted
  4. Switzerland: Results Submitted for Publication in Peer-Reviewed Journal
  5. More Research:

  6. Ibogaine: Ethics Committee Approves Observational Study in New Zealand
  7. Medical Marijuana: DEA Lawyers Struggle to Respond to Opening Brief
  8. Fundraising:

  9. Thanks to Our Supporters for Making Our Work Possible
  10. Media:

  11. MAPS in the Media
  12. Video: Could MDMA Have Been Designed with Psychotherapy in Mind?
  13. Video: MDMA Debate at Breaking Convention
  14. Events:

  15. Students for Sensible Drug Policy Conference: March 24-25, 2012, Denver, CO
  16. 8th International Amazonian Shamanism Conference: July 14-21, 2012, Iquitos, Peru
  17. More News:

  18. Clinical Team Expands to Meet Demands of Growing Research Program

MDMA/PTSD Research

1. U.S. Intern Study: IRB Grants Conditional Approval, Protocol Submitted to FDA

On March 8, 2012, the protocol for our planned intern study of MDMA-assisted psychotherapy for PTSD received conditional approval from the Instititional Review Board (IRB) pending a few minor modifications to study documents. The protocol was submitted to the FDA on February 27, and is now awaiting review. This study will take place in Boulder, CO, and will explore the effectiveness of MDMA-assisted psychotherapy when one member of the male/female co-therapist team is an experienced therapist and the other is an intern working under supervision for credit towards licensure. This approach will help train a new generation of therapists as well as help reduce study costs. The key question is whether outcomes will be similar to when the male/female co-therapist team is composed of two trained therapists.

The protocol was submitted to the IRB on March 1 and reviewed on March 8, the same day conditional approval was granted. This study will take place in Boulder, Colorado, and will be our second U.S. trial site. The study will explore the effectiveness of MDMA-assisted psychotherapy for PTSD using two different doses of MDMA (125 mg followed by a 62.5 mg supplemental dose, and 40 mg followed by a 20 mg supplemental dose). We are evaluating whether a slightly larger low dose (40 mg) than in our previous studies will be a way to create an effective double blind with just two treatment groups. The study will also enable us to make formal comparisons of the effectiveness of the therapy between different therapeutic teams. The Boulder team will participate in our therapist training program in Charleston, SC, from April 8-11, 2012, before beginning the study.

We have already received pledges of $125,000 for this study—about half the total cost—and are seeking the remaining $125,000.

MDMA/PTSD Research Worldwide
MAPS is planning or conducting Phase 2 studies of
MDMA-assisted psychotherapy for PTSD across the globe.

2. U.S. Relapse Study: First Subject Treated

On February 22, 2012, the first subject was treated in our relapse study of MDMA-assisted psychotherapy for subjects whose PTSD symptoms returned after participating in our now-completed U.S. "proof of principle" study. The initial results are promising. While the long-term follow-up to this study found that the therapeutic benefits of MDMA-assisted psychotherapy were on average sustained over time, two subjects experienced a relapse. This study is an open-label proof-of-principle study, intended to determine whether a single additional MDMA-assisted psychotherapy session and four non-drug psychotherapy sessions can once again eliminate these subjects' PTSD symptoms. We are seeking $20,000 to complete this study.

3. U.S. Veterans Study: Sixth Subject Treated, Protocol Amendments Accepted

On February 25, 2012, the sixth subject was treated in our ongoing U.S. study of MDMA-assisted psychotherapy for veterans with PTSD. The fourth protocol amendment (PDF) for this study received "unconditional approval" from the Institutional Review Board on February 22. The FDA has until March 10 to complete its own review. The amendments include expanding the study from 16 to 24 subjects, adding the possibility of enrolling local firefighters and police officers with work-related PTSD, and changing outcome assessment procedures to enable more exact comparisons with other studies. The clinical team is now working on incorporating the amendments into study documents. We have raised the funds for the initial 16 subjects and are now developing the budget for the additional eight subjects.

4. Switzerland: Results Submitted for Publication in Peer-Reviewed Journal

On February 27, 2012, the lead investigator for our now-completed Swiss pilot study of MDMA-assisted psychotherapy for 12 subjects with chronic, treatment-resistant PTSD submitted a paper describing the results to a peer-reviewed scientific journal. The paper is co-authored by Clinical Investigator Peter Oehen, M.D., and Ulrich Schneider, M.D., former president of the International Society for Traumatic Stress Studies. The study found clinically significant reductions in scores on the Clinician-Administered PTSD Scale (CAPS)—larger than those associated with Zoloft and Paxil, which are the currently approved medications for PTSD. The small number of subjects in this preliminary pilot study contributed to the results approaching but not reaching statistical significance. The investigators are now awaiting the reviewers' response to their submission.

More Research

5. Ibogaine: Ethics Committee Approves Observational Study in New Zealand

Geoff Noller, Ph.D.
Dr. Geoff Noller

On February 22, 2012, our new observational study of ibogaine treatment for addiction in New Zealand received final approval (PDF) from the Multi-region Ethics Committee. The new study will examine the safety and long-term effectiveness of ibogaine treatment for addiction severity and quality of life in 20 to 30 patients. Since this is an observational study, the study requires no further approvals. Dr. Geoff Noller, Ph.D., the lead investigator for the study, is now recruiting subjects. Dr. Noller writes:

"I'm delighted at the approval of this internationally funded study. It's a new opportunity to collect quality data on an exciting development in the field of addiction treatment, of which New Zealand is on the cutting edge. Moreover, comparing data with MAPS' similar ongoing study in Mexico will enable further insights into appropriate treatment regimes and international best practices regarding ibogaine."
The New Zealand study is based in the South Island city of Dunedin, where the research team will work closely with an independent ibogaine treatment provider. Other providers throughout the country have also been approached for participation. We have received $15,000 in contributions for this study, with another $20,000 still needed.

6. Medical Marijuana: DEA Lawyers Struggle to Respond to Opening Brief

Lyle Craker, Ph.D.
Lyle Craker, Ph.D.

On February 22, 2012, the Drug Enforcement Administration requested a second extension on the deadline for filing its response brief in UMass-Amherst Prof. Lyle Craker's federal lawsuit against the agency. The DEA now has until March 16 to file its response brief. Prof. Craker, with pro bono legal services from Washington, D.C., law firm Covington & Burling LLP and the ACLU of Northern California, is suing the DEA for refusing to accept a DEA Administrative Law Judge's recommendation that it would be in the public interest to grant him a license to grow marijuana under contract to MAPS exclusively for federally regulated medical research.

The second extension request suggests that the DEA is having a difficult time responding to our initial brief (232-page PDF). Prof. Craker's legal team discovered that the DEA used one set of criteria to reject his license application, and a completely opposite set of criteria for other license applications both before and after his own. MAPS' struggle to overcome political obstruction of our medical marijuana drug development efforts will still take years. In the meantime the DEA's continued refusal to open the door for FDA-approved research highlights the continued need for state-level medical marijuana reform efforts. The suppression of science, like the suppression of religion, is a violation of basic human rights.

Fundraising

7. Thanks to Our Supporters for Making Our Work Possible

All of our research and educational projects are funded by visionary individuals and family foundations. MAPS sincerely thanks the following donors for supporting our important work to create medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and medical marijuana:

  • Ian Brown, for $10,000 to support our research and educational projects
  • The Feilding Foundation, for $7,500 for our upcoming U.S. veterans study
  • Jeffrey Crawford, for $5,000 towards our research and educational projects
  • Julie Holland, for $1,188 for our medical marijuana research efforts
  • Ben Warner, for $1,000 for our research and educational projects
MAPS additionally received 244 gifts in February for a total of $11,091, ranging from $5 to $800. Many of these smaller gifts were made easily and securely through automatic payments. MAPS also received three large donations last month for a total of $310,000, as reported in our last newsletter. If you would like to join these donors in helping us change the world, call 1 (831) 624-6362, or visit maps.org/donate.

Media

8. MAPS in the Media

Local and national media continue their coverage of important developments in the field of psychedelic research, from cutting-edge treatments and exciting educational events to the challenges of treating PTSD in the military. Here are some of the top hits from the last month:

  • The New York Times reports that a single diagnosis of PTSD can cost $1.5 million in taxpayer-funded benefits over a soldier's lifetime. This not only gives military commanders an incentive to issue unwarranted diagnoses to get rid of unwanted troops, but also highlights the pressing need for MAPS' research into cheaper and more effective treatments for PTSD. (February 24, 2012)

  • City on a Hill Press reports on "Shattering Certainty: The Promises and Pitfalls of Psychedelics," an evening lecture hosted by the UC Santa Cruz Brain Mind & Consciousness Society James Fadiman, Ph.D., author of The Psychedelic Explorer's Guide: Safe, Therapeutic, and Sacred Journeys (in the MAPS Store) addressed an overflowing auditorium of students and local community members about what researchers know about the risks and benefits of psychedelics. (February 23, 2012)

  • The Santa Cruz Patch reports that the dissociative anesthetic ketamine, which is both a legal anesthetic and a popular recreational drug, could have fast-acting, though perhaps short-lived, antidepressant properties. Now, a series of new studies are once again renewing interest in the therapeutic properties of ketamine and its chemical cousins. (February 9, 2012)
Check out MAPS in the Media for even more psychedelic and medical marijuana research news.

9. Video: Could MDMA Have Been Designed with Psychotherapy in Mind?

On February 28, 2012, UK psychiatrist Ben Sessa, M.D., gave an outstanding lecture on the topic of "MDMA: Could It Have Been Designed with Psychotherapy in Mind?" The talk was part of an ongoing Ecology, Cosmos, and Consciousness lecture series taking place at the October Gallery in London.

"I've seen the anguish of patients for whom traditional treatments have been unable to help resolve their past traumas," says Dr. Sessa. "MDMA has unique properties that make it the ideal candidate for offering a psychotherapeutic way out—almost as if it was specifically designed for this purpose. We must tread carefully to maneuver this medicine back into mainstream practice by meeting the rigorous standards of modern psychopharmacology research—even by being conservative if that is what is necessary—in order to achieve the goal of returning MDMA to a place in mainstream psychiatry. We owe it to our patients to do this."
Dr. Sessa, along with former UK drug policy advisor David Nutt, M.D., is currently exploring funding opportunities for a future study of MDMA-assisted psychotherapy for PTSD in the UK. MAPS will provide training to the UK co-therapist team and assist with the protocol approval process.

10. Video: MDMA Debate at Breaking Convention

On April 2-3, 2011, the University of Kent at Canterbury hosted Breaking Convention: A Multidisciplinary Conference on Psychedelic Consciousness. The first day of the conference featured a rousing debate on the relative risks and benefits of MDMA.


Thanks to MAPS intern Bryce for making this available!

Thanks to the participation of an engaged and knowledgeable audience, the debate addressed many issues not commonly addressed in the scientific literature or popular press. Topics include: the politicization of psychedelic research, the ways that selective data analysis can be used to emphasize risk vs. safety, the effects of publication bias, and what happens when experts are consulted for their professional opinion. Other major themes include the relative risk/benefit ratio of clinical MDMA vs. recreational Ecstasy and the role of set and setting in helping determine this ratio. The debate was moderated by Ben Sessa, M.D., and includes MAPS founder and executive director Rick Doblin, Ph.D., Swiss MDMA-assisted psychotherapy researcher Peter Oehen, M.D., and psychopharmacology researchers Jon Cole, Ph.D., Val Curran, M.D., and Andy Parrott, Ph.D. Click here for the full debate transcript (PDF).

Events

11. Students for Sensible Drug Policy Conference: March 24-25, 2012, Denver, CO

Join Students for Sensible Drug Policy from March 23-25, 2012, at the Hyatt Regency Denver Tech Center for their 13th annual conference focused on exploring alternatives to the war on drugs. Topics range from the emerging medical cannabis industry and criminal justice to international drug policy and harm reduction. Keynote addresses will be given by MAPS founder and executive director Rick Doblin, Ph.D., and Drug Policy Alliance founder and executive director Ethan Nadelmann, Ph.D. Register today!

12. 8th International Amazonian Shamanism Conference: July 14-21, 2012, Iquitos, Peru

The 8th International Amazonian Shamanism Conference will take place from July 14-21, 2012, in Iquitos, Peru. More than 200 attendees will participate in the weeklong event, which will feature talks, tours, and workshops with artists, researchers, authors, and spiritual leaders from around the world. Learn more about this fascinating event.

More News

13. Clinical Team Expands to Meet Demands of Growing Research Program

While we have a long way to go, MAPS is making significant progress in conducting the research necessary to make MDMA-assisted psychotherapy legally available for people suffering from PTSD. With two completed studies, two ongoing, and five in development around the world, our growing research program is placing new demands on our highly skilled clinical team. The MAPS clinical team is meeting that challenge, and going beyond.

MAPS is happy to announce that Amy Emerson was recently promoted to the newly created position of Director of Clinical Research. She has worked with MAPS since 2003, and previously held a management role at Novartis pharmaceutical company overseeing the conduct of a number of clinical research studies. Amy has hired and trained what we are proud to call our "refugees" from the pharmaceutical industry, whose skill and experience enable us to conduct research at the level of the largest pharmaceutical companies, at a fraction of the cost.

MAPS Clinical Team: Boulder Study

MAPS' clinical team meets for upcoming MDMA/PTSD intern study at Cartographie Psychedelica (Image: Geneva Photography)
Left to right: Marcela Ot'alora, M.A., L.P.C., Boulder study lead investigator; Katie Hendy, Ph.D. cand., clinical intern; Amy Emerson, Director of Clinical Research; Katya, Clinical Research Associate; Berra Yazar-Klosinski, Ph.D, Lead Clinical Research Associate; Will Van Derveer, M.D., Boulder study physician; Daniel, Boulder study intern therapist; Alison, Boulder study intern therapist; Ilsa Jerome, Ph.D., Research & Information Specialist.
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