This open-label, phase 2 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.
Compound MDMA
Country United States of America
Visit trial
Status
Not yet 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 UniversityBrown 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.