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MAPS Bulletin Summer 2014: Research Edition
 
Media > Newsletter: July 9, 2004



Greetings, MAPS members and friends!

These have been very busy and productive times for the MAPS staff, as we've been traveling to conferences and out of the office for several weeks. In early June, we were at the International Transpersonal Association conference in Palm Springs, California, at which MAPS sponsored a series of psychedelic-related talks and brought together all three researchers with FDA approval to conduct psychedelic therapy research. We also brought ibogaine treatment providers from Mexico and Canada and our ibogaine/addiction outcome study team (video and audio files from some of these talks will be made available on the MAPS website). In late June, we went to Bath, England for the Exploring Consciousness conference, which has linked MAPS with researchers in England seeking to start psychedelic research in that country.

Here's the news from MAPS this summer:

1. Protocol submitted to IRB for study of MDMA in the treatment of advanced stage cancer patients with anxiety

2. South Carolina MDMA/PTSD study progressing smoothly

3. Ibogaine outcome study underway with preliminary data gathering

4. MAPS sends letter to NIDA Director and National Advisory Council on Drug Abuse urging action on long-delayed review of vaporizer protocol, receives unhelpful reply.

5. MAPS sends Dr. Lyle Craker, UMass Amherst, to Third National Clinical Conference on Cannabis Therapeutics

6. MAPS explores lawsuit against DEA/HHS/NIDA for unreasonable delay in reviewing medical marijuana research projects

7. MAPS gatherings take place at Laura Huxley's home in LA and at Ridge Farms in England.

8. MAPS House survives a fire, MAPS staff survive no air conditioning

9. Latest MAPS Bulletin mailed to members!

And here's the details:

1. Protocol submitted to IRB for study of MDMA in the treatment of anxiety in advanced stage cancer patients

On June 28, Dr. John Halpern of Harvard Medical School's McLean Hospital submitted a protocol to the McLean Institutional Review Board (IRB) for a MAPS-funded study of MDMA in the treatment of anxiety in advanced stage cancer patients. After years of laying the groundwork for this study, and months of protocol development, we have now formally begun the effort to open a new area of research for MDMA and to restart psychedelic research at Harvard for the first time since 1965. If the McLean IRB approves the study, the protocol will then go to the IRB at Lahey Clinic (where oncologist and co-investigator Dr. Todd Shuster works and from where the subjects will be referred into the study), and then on to FDA. We anticipate that this study will take three to six months to become fully approved and hope to start treating the first subjects in late 2004 or early 2005.

Before MDMA was criminalized in 1985, several psychiatrists and therapists worked with cancer patients with MDMA with positive results in terms of reduced anxiety and pain. In the 1960s and early 1970s, LSD was also used successfully in the psychotherapeutic treatment of cancer patients. MAPS' work to resume this line of research at Harvard represents an important effort to start a new era of psychedelic research, at a culturally symbolic place where many people think it went off the track when Timothy Leary and Richard Alpert (Ram Dass) were kicked out of Harvard.

2. South Carolina MDMA/PTSD study progressing smoothly

Dr. Michael Mithoefer, the chief investigator in the MAPS-sponsored study of MDMA for posttraumatic stress disorder (PTSD), reports that the study is going very smoothly. About 30 potential study subjects have been screened by phone, and of those eight or ten have taken additional steps toward participating. Most of those are still at the stage of scheduling screening visits, some have been enrolled and some have finished the majority of the study visits, including both experimental sessions with MDMA or placebo. The study has had the first scheduled review by the Data Safety Monitoring Board (DSMB). They had no safety concerns and recommended to the Institutional Review Board (IRB) that the study continue. We've also had a very productive site visit from our volunteer Clinical Research Coordinator, Amy Emerson, to review record keeping. There will also soon be a site inspection from a representative of the IRB. The study continues to get a slow but steady stream of referrals, but will still need additional subjects as time goes on.

We are now considering applying to FDA in early 2005 for permission to establish a training program for therapists interested in participating in MAPS' eventual multi-site MDMA/PTSD studies. This training program would include the administration of MDMA to therapists within a clinical context so that they can have a better understanding for the subjective nature of the MDMA experience.

3. Ibogaine outcome study underway with preliminary data gathering

MAPS' ibogaine outcome study, coordinated by MAPS staffer Valerie Mojeiko, has now begun preliminary data gathering for subjects treated at the Iboga Therapy House in Vancouver, Canada and will soon start gathering data on subjects treated at the Ibogaine Clinic in Mexico. We've also discussed expanding the study to include subjects treated in England, where ibogaine is also not illegal. A meeting of the treatment providers and research team that took place at the ITA conference in Palm Springs was quite productive and several public presentations about the project were well received (and soon to be available on the MAPS website).

As a result of meetings in England, MAPS has now expanded its efforts with ibogaine and will work with researchers in England on the development of a protocol for a small pilot study to investigate the use of two ibogaine sessions in the treatment of addiction. The protocol will be used as a tool to raise funds and build a team that will try to start psychedelic research in England.

4. MAPS sends letters to NIDA Director and National Advisory Council on Drug Abuse urging action on long-delayed review of vaporizer protocol, and receives unhelpful reply.

On May 24, MAPS sent letters to NIDA Director Nora Volkow and members of NIDA's National Advisory Council on Drug Abuse urging them to facilitate the NIDA/HHS review of the MAPS/ CaNORML-sponsored vaporizer protocol. Chemic Labs, the analytical lab that will conduct the research, applied to NIDA on June 24, 2003 for permission to purchase ten grams for our research. Almost a year of stonewalling has gone by and there still hasn't been a decision, preventing our research from moving forward. Rick Doblin wrote to Dr. Volkow and said that NIDA was doing an excellent job of providing evidence that NIDA's monopoly on the supply of marijuana for research is seriously compromising privately-funded research.

On June 9, NIDA Director Nora Volkow replied and said, "As you know, NIDA is just one of the participants on the HHS review panel. It is not NIDA's role to set policy in this area. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns.

MAPS is now considering a lawsuit (see item 6 below).

5. MAPS sends Dr. Lyle Craker, UMass Amherst, to the Third National Clinical Conference on Cannabis Therapeutics

Dr. Lyle Craker attended this conference in Charlottesville, Virginia, in late May in order to gather additional information about medical marijuana research, to meet officials from the Dutch Office of Medicinal Cannabis and GW Pharmaceuticals, and to seek support for his MAPS-supported medical marijuana production facility project. He was given an opportunity to address the conference participants about his June 2001 application to DEA for a license for a MAPS-sponsored medical marijuana production facility and he also gathered letters of support to DEA from participants at the conference.

6. MAPS explores lawsuit against DEA/HHS/NIDA for unreasonable delay in reviewing medical marijuana research projects.

MAPS has sponsored an application to DEA, submitted in June 2001, to establish its own medical marijuana production facility at UMass Amherst, under the director of Prof. Lyle Craker. In June 2003, MAPS sponsored an application to DEA from Chemic Labs seeking permission to import ten grams of marijuana from the Dutch Office of Medicinal Cannabis for use in the MAPS/CaNORML vaporizer research project. Chemic also applied to NIDA in June 2003 for permission to purchase 10 grams of NIDA material for use in vaporizer research. No decision has been made by DEA or NIDA/HHS regarding these applications so that MAPS is blocked from growing our own marijuana, importing marijuana or purchasing marijuana from NIDA. MAPS is now actively conducting legal research to determine whether we have grounds to sue DEA/HHS/NIDA under the Administrative Procedures Act, alleging unreasonable delays.

These delays were discussed on the floor of Congress on Wednesday, during the debates on the Farr-Rohrabacher-Hinchey-Paul amendment that would have prohibited the use of federal funds to prevent States that have medical marijuana laws from implementing them. Unfortunately, the bill lost by a vote of 148 (yes) to 268 (no).

Rep. Farr (D-CA) said, "Other opponents of this amendment say that they will not support medical marijuana until more research is complete. The problem is that the Federal Government has effectively blocked research. To cite just one example, in July 2001, the University of Massachusetts applied to the DEA for a license to manufacture marijuana for medical research. This is the same kind of license a company called GW Pharmaceuticals applied for in England a few years ago. While GW Pharmaceuticals has now concluded Phase III trials and is nearing market approval for its marijuana spray, the DEA--3 years later--has not even bothered to deny the University of Massachusetts' license. Of course, they have not granted it, either. They have just let the application sit in limbo.

Another application to the Federal Government, requesting permission to import just 10 grams of marijuana for research has languished for 10 months. Does our government think 10 grams of marijuana is going to increase the drug problem in this Nation? Of course not. The Federal goal seems to be to purposely to block research that would prove--or disprove, once and for all--that marijuana has therapeutic benefits."

7. MAPS gatherings take place at Laura Huxley's home in LA and at Ridge Farm in England.

We are continuing our efforts to bring the MAPS community together, after much success with the gatherings to watch the Peter Jennings' Ecstasy Rising documentary. About 60 people came together at Laura Huxley's home on Saturday, June 19, with talks by Rick, Brandy and Valerie. Dean Chamberlain took a group photo which will soon be posted on the MAPS website. The gathering was inspiring and took place in the same home in which Laura administered LSD to Aldous Huxley in 1963 to facilitate his dying process, described by Laura in her moving classic, This Timeless Moment.

We felt connected to a multi-generational group of psychedelic researchers who, despite periods of repression, will continue to develop this field until there is legal access to psychedelics as tools for therapy, personal growth, creativity, and spirituality.

After the Exploring Consciousness conference in England, a MAPS gathering took place at Ridge Farm, which is the home of a famous recording study where the Rolling Stones and other groups recorded their albums. MAPS members in England and conference participants and organizers attended the gathering, which was a delightful way to forge stronger bonds between MAPS and the British psychedelic community.

8. MAPS House survives a fire, MAPS staff survive no air conditioning

Our Sarasota home that houses the MAPS office caught fire last month, due to a wiring problem in the upstairs sauna. While much of the house suffered water and smoke damage, the firefighters did a great job at containing the fire in the sauna, and the house is structurally intact. The MAPS office was unscathed, and in just a couple of days we were back in action, running from an extension cord plugged in at the neighbors' house. Now we are completely functional again, after a few weeks in the sweltering Sarasota summer without air conditioning. Reconstruction will continue through August. MAPS: Through rain or sleet or fire...

9. New Bulletins arriving!

We are pleased to report that the MAPS Bulletin has been mailed to members. Let us know if you haven't received yours- and let us know what you think!

Best wishes,
Brandy,
--,
Brandy Doyle,
MAPS Projects and Communications Director

p 941.924.6277,
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