A Dose Optimization Study of MDMA-Assisted Therapy for PTSD in U.S. Veterans
Bronx VA Medical Center
Summary
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.
Description
This open label, within-subjects dose optimization study will determine the optimal number of treatment cycles of MDMA-AT (one cycle consists of one Experimental Session followed by three Integrative Sessions) for significant improvement in a sample of U.S. veterans with PTSD. All participants will receive three non-drug preparatory sessions and at least one cycle of MDMA-assisted therapy with a team of two therapists. Each cycle will consist of one approximately 8-hour drug session followed by three 90-minute non-drug integrative sessions. After each cycle, participants will determine, in con…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Are a U.S. military veteran at least 18 years old. 2. Are able to provide written, informed consent. 3. Are able to swallow pills. 4. Agree to have study visits recorded, including Experimental Sessions, psychological assessments, and non-drug therapy sessions. 5. 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. 6. 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…
Interventions
- DrugMidomafetamine
One to five MDMA-assisted therapy sessions, each followed by three non-drug psychotherapy sessions (see behavioral intervention below)
- BehavioralPsychotherapy
Standardized psychotherapy performed by therapy team
Location
- James J. Peters VA Medical CenterThe Bronx, New York