We are currently seeking research volunteers for our second Phase 3 clinical trial of MDMA-assisted therapy for PTSD. Volunteers will help contribute to scientific knowledge and will help us better understand if MDMA-assisted therapy works for treatment of PTSD. MAPS conducts clinical trials under the guidance and regulations of the U.S. Food and Drug Administration (FDA) in collaboration with federal regulators, including the Drug Enforcement Administration (DEA). To learn more about our clinical trials or apply to be a study participant, visit our website.
The study will be conducted in N ≈ 100 participants. Participants will be randomized into one of two groups (MDMA or placebo) in a 1:1 ratio. A flexible dose of MDMA or placebo, followed by a supplemental half-dose unless contraindicated, will be administered during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period will be preceded by three Preparatory Sessions with the participant and therapists. Initial doses in each Experimental Session will be 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate or placebo alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental half-dose (40 or 60 mg, respectively). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg. Each Experimental Session will be followed by three Integrative Sessions of non-drug psychotherapy to help the participants process and understand their experiences during the Experimental Sessions.
We are recruiting participants in the following locations:
- Los Angeles, California, United States
- San Francisco, California, United States (Private Practice)
- San Francisco, California, United States (Institution)
- Charleston, South Carolina, United States
- Boulder, Colorado, United States
- Fort Collins, Colorado, United States
- Boston, Massachusetts, United States
- New York University, New York, United States (Institution)
- New York, New York, United States (Private Practice)
- University of Madison, Wisconsin, United States (Institution)
- Be’er Ya’akov (Merhavim), Israel
- Tel Hashomer, Israel
Not yet recruiting:
- University of British Columbia, Vancouver, British Columbia, Canada
Potential volunteers should contact the study coordinators at each site at clinicaltrials.gov.