RecruitingPhase 2NCT05709353

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

A Randomised, Controlled Trial of MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder


Sponsor

University of Sydney

Enrollment

120 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

To explore the effectiveness of of MDMA-assisted prolonged exposure therapy in improving treatment outcomes for individuals with comorbid PTSD and alcohol use disorder in a double-blind randomised placebo-controlled trial.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether MDMA (commonly known as ecstasy, used here in a controlled medical setting) combined with prolonged exposure therapy can help people who have both alcohol use disorder and PTSD — two conditions that often occur together and are difficult to treat separately. **You may be eligible if...** - You are 18 or older - You have been diagnosed with both PTSD and alcohol use disorder (at least moderate severity) for 6 months or more - You have previously tried treatment for either PTSD or alcohol use disorder - You have stable housing - You can identify someone (family, friend, or partner) who can support you after sessions - You are willing to taper off antidepressants or other conflicting medications under medical supervision **You may NOT be eligible if...** - You have a personal or family history of psychosis or bipolar disorder - You are pregnant or breastfeeding - You are currently going through alcohol withdrawal or have a history of severe withdrawal seizures - You cannot stop certain medications that interact with MDMA - You have a serious heart condition 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALProlonged exposure therapy

COPE represents an integration of existing evidence-based manualised CBT interventions for PTSD and substance dependence (see manual DOI: 10.1093/med:psych/9780199334513.001.0001). COPE used in the current study will represent an integration of existing evidence-based manualised CBT interventions for PTSD and substance dependence. COPE only begins when the participant in a safe environment and no longer in contact with the traumatic event/exposure. COPE employs imaginal and in vivo exposures to treat PTSD and consists of 12 individual 90-minute sessions (i.e. 19.5 hours) delivered by a clinical psychologist.

DRUGMDMA

Administration of 80 to 160 mg MDMA across two 'dosing' sessions. Supplemental doses (additional 40mg during first session, additional 40- 80mg during second session) will be dependent on clinician and participant consensus during preparatory period of 'dosing session'. These supplemental amounts will be dispensed 60 to 90 minutes after initial 80 mg dose.

DRUGNiacin

Administration of niacin 250mg or niacin-matched placebo during two 'dosing' sessions.


Locations(2)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Turning Point

Richmond, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05709353


Related Trials