Dose Optimization of MDMA-Assisted Therapy for PTSD

Recruiting Phase 2 Interventional Study
Posttraumatic Stress Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Bronx VA Medical Center · Federal
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 provid…
Contacts

Amy Lehrner, PhD

718-584-9000

Amy.Lehrner@va.gov

CONTACT