MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder (MPATHY)

This Phase II interventional trial (n=120) explores the effectiveness of MDMA-assisted (8-160mg) prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder (AUD).

Conducted by the University of Sydney in collaboration with Monash University and Sydney Local Health District, the trial aims to address the need for new strategies in treating comorbid PTSD and alcohol dependence. Trauma-focused integrated treatments, such as COPE, have shown support, but only 49% exhibit clinically significant improvements. MDMA may enhance response to COPE, and evidence suggests its potential efficacy in alcohol dependence and PTSD.

The trial adopts a double-blind, randomised, controlled design, enrolling 120 participants for 14 weeks of treatment, including 12 COPE sessions and 2 dosing sessions with MDMA (80-160mg) or control (niacin 250mg). The primary outcome measures the reduction in PTSD symptom severity and heavy drinking. For further information, contact Kirsten C Morley, PhD, at [email protected] or Ellen Towers at [email protected].

Recruitment sites include Drug Health Services, Royal Prince Alfred Hospital in Sydney, New South Wales, and Turning Point in Richmond, Victoria, Australia. The estimated primary completion date is May 2026. Eligibility criteria include individuals aged ≥18 years with comorbid AUD and current PTSD for 6 months or longer, meeting specific cognitive and health requirements.

This trial addresses a critical gap in mental health treatment and holds promise in advancing therapeutic interventions for those with co-occurring PTSD and alcohol use disorder.

Topic PTSD Alcohol Use Disorder Adolescence and Psychedelics
Compound MDMA
Country Australia
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

University of Sydney
The University of Sydney is Australias oldest university. At the psychopharmacology laboratory, researchers have conducted some research with psychedelics.

Monash University
The Clinical Psychedelic Lab, established in 2020, within the Dept Psychiatry at Monash University is the first of its kind in Australia, leading the development and implementation of psychedelic therapies. The lab has played a central role in establishing the field of clinical psychedelic research in Australia.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.