FDA Comments on Special Protocol Assessment for Phase 3 Trials of MDMA-Assisted Psychotherapy for PTSD
The Winter 2016 Annual Report includes updates about MAPS' psychedelic and marijuana research, psychedelic harm reduction, stories from study participants, and upcoming events.
Our highest priority project is funding clinical trials of 3,4-methylenedioxymethamphetamine (MDMA) as a tool to assist psychotherapy for the treatment of posttraumatic stress disorder (PTSD).
We are also sponsoring ongoing clinical trials of MDMA-assisted psychotherapy for anxiety associated with life-threatening illness, and MDMA-assisted therapy for social anxiety in autistic adults.
Preliminary studies have shown that MDMA in conjunction with psychotherapy can help people overcome PTSD, and possibly other disorders as well.
Psychedelic Science 2017 is a six-day global gathering featuring three days of conference programming, full-day workshops, a sunset cruise on the San Francisco Bay, a comedy banquet, a free marketplace of goods and ideas, and much more.
MAPS has recently completed the first double-blind, placebo-controlled study of the therapeutic use of LSD in human beings since the early 1970s.
MAPS is interested in LSD for its potential to help people with a variety of conditions, focusing primarily on the treatment of anxiety associated with life-threatening illness.
Our recently completed Phase 2 pilot study in 12 subjects found positive trends in the reduction of anxiety following two LSD-assisted psychotherapy sessions. The study results also indicate that LSD-assisted psychotherapy can be safely administered in these subjects, and justify further research.
MAPS-sponsored researchers have published observational data from the first prospective ibogaine outcome studies in order to contribute to the growing scientific literature about ibogaine as a treatment for drug addiction.
Although first-hand accounts indicate that ibogaine is not popular as a recreational drug, ibogaine remains classified as a Schedule I drug in the United States (it is also scheduled in Belgium and Switzerland). Yet despite its classification as a drug with a "high potential for abuse" and "no currently accepted medical use," people who struggle with substance abuse continue to seek out international clinics or underground providers to receive ibogaine treatment.
MAPS supports research into the safety and effectiveness of ayahuasca-assisted treatment for drug addiction and PTSD. We also support conferences, meetings, and publications about the scientific, therapeutic, sustainable, and spiritual uses of ayahuasca. We also serve as non-profit fiscal sponsor for organizations that support these uses.
We recently completed the first North American observational study of the safety and long-term effectiveness of ayahuasca treatment for addiction and dependence. The paper describing the results of the study was published in June 2013 in Current Drug Abuse Reviews.
MAPS has been working since 1992 to sponsor FDA-approved clinical studies into the safety and efficacy of botanical marijuana as a prescription medicine for specific medical uses. We've obtained approval from FDA and from Institutional Review Boards for several different protocols but were unable to obtain approval to purchase federally-legal marijuana from the National Institute on Drug Abuse (NIDA).
On March 14, 2014, the U.S. Public Health Service approved our request to purchase NIDA marijuana for our study of smoked whole plant (botanical) marijuana for symptoms of PTSD in U.S. veterans, an historic shift in federal policy. On December 17, 2014, MAPS was awarded a $2.15 million grant from the state of Colorado to conduct the study. The study has received full approval from the FDA, DEA, and Institutional Review Boards (IRBs). We anticipate starting the study in the summer of 2016 at Johns Hopkins University and in Phoenix, Ariz.
Information is shared openly and clearly. Communications are respectful, honest, and forthright.
We persist in the face of challenges. We have a sense of urgency about our work, and know that it's a long-term effort.
Our decisions are informed by research. We try new things and learn from our mistakes.
We value integrity and honesty, and embrace high standards.
