From the Desk of Rick Doblin, Ph.D. – Summer 2013

Summer 2013 Vol. 23, No. 2 Research Edition

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It has taken work across several generations, and will likely require several generations more, to realize the goals of the Multidisciplinary Association for Psychedelic Studies (MAPS), which I started 27 years ago in 1986. With such a long-term perspective and wide range of projects, our challenge continues to be finding sustainability over time, and keeping in a healthy balance the many different communities of which we are a part.

The broad mission of MAPS is to work toward the reintegration into our culture of psychedelics and marijuana and the experiences they engender. Our strategy is to focus primarily on non-profit drug development research—aimed at FDA approval for the prescription use of psychedelics and marijuana—while also engaging to a lesser extent in research about non-medicinal potentials. Conducting supplementary public education and psychedelic harm reduction are also key elements of our mission.

We currently have seven studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) initiated or in the final stages of the approval process. We are sponsoring Phase 2 pilot studies (see page XXX to learn more about Phase 2 studies) in South Carolina, Colorado, Canada, and Israel, along with a Phase 1 MDMA-assisted psychotherapist training protocol and a Phase 2 Relapse Study for the few people in our initial study who improved after treatment but later redeveloped PTSD symptoms. We anticipate holding our crucial End-of-Phase 2 meeting with the Food and Drug Administration (FDA) in about two years. In this meeting we will plan our two pivotal multi-site Phase 3 studies designed to gather proof of safety and efficacy required for prescription approval for MDMA-assisted psychotherapy for PTSD.

We’ve also obtained FDA approval and are in the middle of the IRB approval process for a pilot study examining MDMA-assisted therapy’s possible role in reducing social anxiety in autistic adults, to take place at the Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. In addition, we recently received a $10,000 donation from Shlomi Raz to develop a protocol for a study of LSD for problem solving and creativity.

While our psychedelic research grows, our efforts to start medical marijuana research remain unsuccessful (despite 20 U.S. states plus the District of Columbia now allowing the legal use of medical marijuana). On April 15, 2013, we were defeated in our 12-year struggle to help Prof. Lyle Craker of the University of Massachusetts-Amherst obtain a Drug Enforcement Administration (DEA) license to grow marijuana under contract to MAPS for federally regulated medical research. Craker’s unsuccessful lawsuit against the DEA for rejecting a DEA Administrative Law Judge’s prior recommendation that it would be in the public interest to grant Craker’s license means that the National Institute on Drug Abuse (NIDA) has retained its monopoly on the supply of marijuana legal for federally regulated research.

Our FDA-approved pilot study of marijuana for 50 veterans with chronic, treatment-resistant PTSD, for which NIDA has refused to sell us the required marijuana, remains on hold until we can persuade the Public Health Service review committee that previously rejected the protocol to allow it to proceed now that we have also obtained approval from the Institutional Review Board at the University of Arizona.

With an expanding clinical research program, we also have an expanded obligation to educate the public about our research data and its implications for public health and culture. I recently spoke with The New York Times about how the explosion of media interest in “Molly,” the newest hip name for illegally distributed Ecstasy, in part reflects the younger generation’s need for connection and community.

The summer festival season has been the perfect time to expand our public education work, with an outstandingly successful Indiegogo campaign for the Zendo Project harm reduction services. We have over 100 volunteers joining us this year in Black Rock City to help provide compassionate support for people having difficult psychedelic experiences. In addition to providing a supportive space and reducing the number of drug-related arrests and hospitalizations, our psychedelic harm reduction program also provides a context for us to help train the next generation of psychedelic therapists.

By developing a model psychedelic harm reduction program, we’re working to reduce the public’s fear of psychedelics, further encouraging research and reducing the potential of a cultural backlash. We’re doing this by demonstrating that it is possible to reduce the risks associated with the non-medical use of psychedelics used outside of scientific and therapeutic contexts.

MAPS is more than just an organization: We are a broad international community of researchers, therapists, doctors, artists, activists, students, policymakers, journalists, and just regular people, and we are creating safer spaces to explore both the risks and the benefits of psychedelics and marijuana for science, medicine, spirituality, and exploration.

This edition of the MAPS Bulletin is an invitation to discover what’s new and become more involved in our increasingly mainstream community.

With appreciation and excitement for all we’re doing together,

Rick Doblin, Ph.D.

MAPS Executive Director