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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Both AUD and current PTSD according to the DSM-5 criteria, for 6 months or longer with at least moderate severity, according to investigator judgement and CAPS-5

• Aged ≥18 years old

• Adequate cognition and English language skills to give valid consent and complete research interviews assessments

• Willing to give written informed consent

• Received prior treatment for PTSD or AUD (not including study interventions)

• Stable housing

• Able to identify a significant other (such as a family/friend/partner) who could accompany them from clinic/provide transport and/or be contacted by the study team if required

Locations
Other Locations
Australia
Turning Point
NOT_YET_RECRUITING
Richmond
Drug Health Services, Royal Prince Alfred Hospital
RECRUITING
Sydney
Contact Information
Primary
Kirsten C Morley, PhD
Kirsten.morley@sydney.edu.au
61295153636
Backup
Ellen Towers
ellen.towers@sydney.edu.au
Time Frame
Start Date: 2023-09-19
Estimated Completion Date: 2026-05
Participants
Target number of participants: 120
Treatments
Experimental: COPE + MDMA
4x COPE sessions~Dose 1:~2x MDMA capsules (80mg) + 1x niacin-matched placebo capsule~Optional supplementary dispense:~1x MDMA capsule (40mg)~4x COPE sessions~Dose 2:~2x MDMA capsules (80mg) + 1x niacin-matched placebo capsule~Optional supplementary dispense:~1x OR 2x white MDMA capsule (40 or 80mg)~4x COPE sessions
Other: COPE + Niacin (Control)
4x COPE sessions~Dose 1:~2x MDMA-matched placebo capsules + 1x niacin capsule (250mg)~Optional supplementary dispense:~1x MDMA-matched placebo capsule~4x COPE sessions~Dose 2:~2x MDMA-matched placebo capsules + 1x niacin capsule (250mg)~Optional supplementary dispense:~1x OR 2x MDMA-matched placebo capsule~4x COPE sessions
Related Therapeutic Areas
Post-Traumatic Stress Disorder (PTSD)
Sponsors
Collaborators: Monash University, Sydney Local Health District
Leads: University of Sydney

This content was sourced from clinicaltrials.gov

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