An Open Label, Phase 2, Single-arm Pilot Study to Investigate the Safety and Preliminary Effectiveness of MDMA-assisted Therapy in Veterans With Co-occurring Alcohol Use Disorder and Post-traumatic Stress Disorder (AUD-PTSD)
The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.
- Status
- recruiting
- Phase
- Phase 2
- Institution
- Carolina L Haass-Koffler
- Start date
- 2024-02-06
- End date
- 2026-01-30
- Registry ID
- NCT05943665
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.