As we approach the end of 2013 and look ahead to 2014, the Multidisciplinary Association for Psychedelic Studies (MAPS) has more opportunities than at any other time in our entire 27½ year history.
We currently have four Phase 2 pilot studies of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD) underway—in Charleston, SC; Boulder, CO; Vancouver, Canada; and Beer Yaakov, Israel—and have obtained promising results from our two completed Phase 2 studies in Charleston, SC, and Solothurn, Switzerland. We are also in discussions with the U.S. Veterans Administration (VA) regarding a possible collaborative study of MDMA-assisted psychotherapy in subjects with war-related trauma.
While it’s not clear if we can establish a collaboration at this time with the VA, we’ve never been this far before and it’s starting to seem more like a question of “when” rather than “if.” We’re also simultaneously working on a grant application to the National Institute of Mental Health (NIMH) for our MDMA-assisted psychotherapy research for PTSD—it’s a long shot, but success is not out of the question.
The path ahead of us is open to our End-of-Phase 2 meeting with the Food and Drug Administration (FDA) in about 2½ years, the outcome of which (we anticipate) will be an agreement on the design of our Phase 3 MDMA-assisted psychotherapy for PTSD studies. Fortunately, due to a generous bequest from Ashawna Hailey, we have already set aside $5.3 million in restricted funds to be used toward the currently estimated cost of about $16 million for two large-scale, multi-site, Phase 3 studies. These Phase 3 studies are required to demonstrate safety and efficacy prior to the approval of MDMA-assisted psychotherapy as a prescription treatment by the FDA, which we expect to take place in 2021.
For the first time ever, we’re even able to envision MAPS as a sustainable non-profit with income from sales of prescription MDMA covering some or all of MAPS’ future research and educational projects. The article “Building a Sustainable Non-Profit through MDMA Research” on page XX discusses the assumptions on which we’ve based our projections, including income, expense, and net income estimates for 2022 through 2031.
In early 2014, we’re going to be starting our study of MDMA-assisted therapy for social anxiety in adults on the autism spectrum, to take place at Harbor-UCLA Medical Center/Los Angeles Biomedical Research Institute. We are also seriously considering whether to start developing a new study of the therapeutic use of MDMA-assisted therapy for anxiety, depression, and pain associated with advanced-stage illness.
We’re also anticipating that by early 2014, a peer-reviewed journal will have accepted for publication our paper on the results of our Swiss study of LSD-assisted psychotherapy in subjects with anxiety related to advanced-stage illness. We’ve already resubmitted our revised paper after taking into consideration the initial reviewer comments. We are likely very close to publishing the results of the first LSD-assisted psychotherapy study in over 40 years. The promising results from this initial pilot study have created new opportunities for additional LSD research worldwide.
Even MAPS’ efforts to start medical marijuana drug development research—which we began working towards 21 years ago in partnership with Donald Abrams, M.D., at the University of California, San Francisco, but which remains blocked by the National Institute on Drug Abuse (NIDA) monopoly on the supply of marijuana legal for FDA-regulated research—may start moving forward in 2014. The article “Will the Obama Administration Stop Standing in the Way of Marijuana Research for Veterans?” on page XX discusses the resubmission to the Public Health Service (PHS) of our now FDA and University of Arizona IRB-approved protocol to study marijuana in U.S. veterans with chronic, treatment-resistant PTSD. Our arguments for ending the obstructive PHS review process are also starting to gain traction among members of Congress.
Even our 12-year struggle to start our own medical marijuana production facility in partnership with Prof. Lyle Craker of the University of Massachusetts-Amherst, which has been successfully blocked by the Drug Enforcement Administration (DEA), may become possible in the years to come. Once we’re able to import medical grade marijuana produced in Israel, Canada or the Netherlands, probably in about two to three years, the NIDA monopoly will have effectively ended and DEA resistance to domestic production is likely to decrease.
The continued support from MAPS supporters has brought us to this place of great opportunity. As a result, we’re increasingly realistic rather than quixotic in our quest to mainstream the careful uses of psychedelics and marijuana, and the healing and spiritual growth that they can catalyze. We won’t take progress for granted, and are proceeding carefully. As I turn 60, I can see that by 70, the dream I had as an 18-year old has an excellent chance of being realized.