RecruitingPhase 2NCT05943665

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)

Sponsor

Carolina L Haass-Koffler

Enrollment

18 participants

Start Date

Feb 6, 2024

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder Alcohol Use Disorder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether MDMA-assisted therapy can help military veterans who are struggling with both post-traumatic stress disorder (PTSD) and alcohol use disorder at the same time. MDMA is being studied as a tool to make therapy sessions more effective for people with these overlapping conditions. **You may be eligible if...** - You can prove you are a military veteran - You speak and read English fluently - You meet the criteria for both alcohol use disorder and PTSD (based on clinical interviews) - Your PTSD has lasted at least 6 months, with a significant symptom score (PCL-5 ≥ 33, CAPS-5 total ≥ 28) - You can safely stop drinking alcohol for at least 48 hours without needing medical detox - You are not currently taking antidepressants or antipsychotics - You can provide a supportive contact person (friend, family member, etc.) **You may NOT be eligible if...** - You have a serious heart condition or are taking heart medications - You have a history of psychosis or certain other psychiatric conditions - You are currently pregnant or nursing - You are actively suicidal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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