Actively Recruiting
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
Led by University of Sydney · Updated on 2023-11-07
120
Participants Needed
2
Research Sites
136 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MDMA-assisted Prolonged Exposure Therapy for Comorbid Alcohol Use Disorder and Post-traumatic Stress Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with both alcohol use disorder and current PTSD for 6 months or longer, with at least moderate severity
- Adequate cognition and English skills to give consent and complete assessments
- Willing to provide written informed consent
- Previous treatment received for PTSD or alcohol use disorder (excluding study treatments)
- Stable housing situation
- Able to identify a significant other who can accompany them or be contacted by the study team if needed
You will not qualify if you...
- History or current diagnosis of psychotic or bipolar disorders, or major depression with psychotic features
- Pregnant or lactating women
- Significant alcohol withdrawal or history of severe withdrawal complications
- Current use of psychotropic medications unless properly tapered off
- Use of medications that may interact with MDMA and inability or unwillingness to stop them during the trial
- Substance use disorder other than tobacco (e.g., benzodiazepines, cannabis)
- History or current cardiac disease, uncontrolled blood pressure, abnormal ECG, stroke, liver disease, epilepsy, or related serious medical conditions
- Suicide risk as judged by clinicians and standardized assessments
- Unstable systemic medical or psychiatric conditions requiring hospitalization
- Regular ecstasy use (at least twice in last 6 months or more than 10 times in last 5 years)
- Participation in other interventional clinical trials within two months or during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Actively Recruiting
2
Turning Point
Richmond, Victoria, Australia, 3121
Not Yet Recruiting
Research Team
K
Kirsten C Morley, PhD
CONTACT
E
Ellen Towers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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