NCT05943665

MDMA for AUD/PTSD Comorbidity

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Carolina L Haass-Koffler · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will use a longitudinal design to conduct an open label pilot trial of MDMA-AT. The study will also collect neuroimaging and biomarker data to examine brain changes pre-post treatment. Eligible participants will complete an in-person baseline assessment, undergo optional imaging protocols (if participant agrees and is medically safe to do so), engage in MDMA-AT with clinicians trained by MAPS PBC, and complete assessments at the post-treatment follow-up For complete description of the investigational plan, please the attached Clinical Protocol.

Conditions

• Alcohol Use Disorder
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DRUG	MDMA	medication and therapy combined

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-01-21
• Completion: 2026-01-30
• First posted: 2023-07-13
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study