MDMA, the once-maligned “club drug,” is finding new life among psychiatrists, who have achieved remarkable success in treating patients with chronic PTSD. The process of bringing MDMA into the mainstream has been decades in the making, but occasionally there are moments when it seems to speed up. One of those moments happened on Thursday, as the Multidisciplinary Association for Psychedelic Studies (MAPS) announced that it has opened five clinical trial sites for enrollment inquiries.
People who live with severe PTSD can now submit their name for the possible opportunity to receive MDMA-assisted psychotherapy.
MAPS, a non-profit psychedelic medicine research organization that’s been at the forefront of the effort to bring MDMA-assisted therapy into the mainstream, is sponsoring the Phase 3 trial — the final phase before the US Food and Drug Administration can approve a drug for medical use.
Scientists associated with MAPS are recruiting participants at five trial sites across the US.
These Sites Are Open for Inquiries
The following five trial sites are open for enrollment inquiries for people who live near them:
- North Hollywood, California
- Boulder, Colorado
- Fort Collins, Colorado
- New Orleans, Louisiana
- Mount Pleasant, South Carolina
For more information on eligibility and to find out how to sign up, visit the ClinicalTrials.gov page for this trial.
These Sites Will Be Open Soon
While only five sites are currently open for screening potential trial subjects, the following nine sites will be opening “soon,” according to MAPS:
- San Francisco Insight and Integration Center
- University of California, San Francisco
- Trauma Research Foundation (Boston)
- New York University
- Affective Care (New York, NY)
- Providence Health Center (Vancouver, BC, Canada)
- Dr. Simon Amar LLC (Montreal, Québec, Canada)
- Be’er Ya’akov Mental Health Center (Israel)
- Sheba/Tel Hashomer (Israel)
Inclusion Criteria for the Trial
Of course, submitting your name for consideration does not guarantee a spot in the clinical trial, as it will only involve between 100 and 150 subjects, and eligibility criteria could also be a limiting factor for some people. According to the federal clinical trials registration, suitable subjects must meet all of the following criteria:
- Are at least 18 years old
- Are fluent in speaking and reading the predominantly used or recognized language of the study site
- Are able to swallow pills
- Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug psychotherapy sessions
- Must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
- Must agree to inform the investigators within 48 hours of any medical conditions and procedures
- If of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Must not participate in any other interventional clinical trials during the duration of the study
- Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures
- At baseline, meet DSM-5 criteria for current severe PTSD
The clinical trial, which will compare the effectiveness of MDMA-assisted therapy to that of a placebo, will include 15 sessions over a 12-week period. Three of those sessions will include either MDMA or a placebo, while the rest will be either preparatory or “integration” sessions meant to help subjects unpack the issues brought up during the drug sessions.
So far, results have been promising. The results of a Phase 2 trial, published in May in The Lancet, showed that 68 percent of participants who received a full dose of MDMA no longer met the criteria for PTSD diagnosis one month after their second session. And while a Phase 2 trial is mostly meant to find the proper therapeutic dose, these results suggest that the Phase 3 trials could confirm what many researchers have suspected about MDMA’s potential to heal.
“If the Phase 3 trials demonstrate significant efficacy and an acceptable safety profile, FDA approval is expected by 2021,” MAPS stated on Thursday. “Once approved, MDMA-assisted psychotherapy would only be available by prescription in supervised therapeutic settings from specially trained mental health providers.”