A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
This open label, within-subjects dose optimization trial will investigate the optimal number of MDMA-Assisted Therapy treatment cycles (i.e., one MDMA session and three integration sessions) in a sample of U.S. veterans with PTSD. Participants will complete from one to five cycles of MDMA-AT.
• Are a U.S. military veteran at least 18 years old.
• Are able to provide written, informed consent.
• Are able to swallow pills.
• Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions.
• Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.
• If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraceptive methods.
• Must have a current PTSD diagnosis at screening and baseline.
• Must not participate in any other interventional clinical trials for the duration of the study.
• Must commit to medication dosing, therapy, and all study procedures.