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.
Trial Details
New strategies for the treatment of comorbid PTSD and alcohol dependence are urgently required. Recent evidence has shown strong support for trauma-focused integrated treatments (namely COPE), however only 49% demonstrate clinically significant improvements. MDMA may be a promising approach to improve response to COPE for this population. Emerging evidence suggests that MDMA-assisted therapy may be of promise for PTSD, and has demonstrated a good safety profile and potential efficacy in alcohol dependence. This project will evaluate the clinical efficacy and tolerability of MDMA-assisted COPE relative to a placebo-assisted COPE. The investigators hypothesise that MDMA treated patients will be have a reduction in PTSD symptom severity as well as heavy drinking. The trial will utilise a double blind, randomised, controlled design. A sample of 120 individuals will receive 14 weeks of treatment including 12 COPE sessions and 2 dosing sessions with MDMA (80-160mg) or placebo.NCT Number NCT05709353
Sponsors & Collaborators
University of SydneyThe 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.