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

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.

Conditions

• PTSD
• Alcohol Use Disorder
• Alcohol Dependence
• Post-traumatic Stress Disorder
• Comorbidities and Coexisting Conditions

Interventions

BEHAVIORAL

Prolonged 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.

DRUG

MDMA

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.

DRUG

Niacin

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

Sponsors & Collaborators

• Monash University

  collaborator OTHER

• Sydney Local Health District

  collaborator OTHER_GOV

• University of Sydney

  lead OTHER

Principal Investigators

• Kirsten C Morley, PhD · University of Sydney

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-19

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Australia

Study Locations