MDMA for AUD/​PTSD Comorbidity (MDMA)

This open-label, Phase II trial (n=18) will investigate the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in military veterans with co-occurring Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).

The unique treatment approach involves two once-monthly experimental therapy sessions, combined with a divided dose of MDMA, supplemented by non-drug preparatory and integrative therapy. The primary outcome measure, the Timeline Follow-back, will be used to assess changes in alcohol use over time, while PTSD symptoms will also be evaluated. Additional data will be collected via neuroimaging and biomarkers to study brain changes before and after treatment.

Find the study design here.

Topic Alcohol Use Disorder Addiction PTSD
Compound MDMA
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 01 September 2023
End date 01 September 2024
Chance of happening 100%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 18
Sex All
Age 18- 99
Therapy Yes

Trial Details

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.

NCT Number NCT05943665

Sponsors & Collaborators

Brown University
Brown University, under the leadership of researcher Carolina Haass-Koffler, is actively involved in an innovative clinical trial studying the safety and preliminary effectiveness of MDMA-assisted therapy.

Data attribution

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