Actively Recruiting
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Led by Stephen Robert Marder · Updated on 2025-03-28
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This randomized, double-blind, single-site phase II 2-arm study will investigate the safety and preliminary efficacy of MDMA-assisted therapy compared with low dose d-amphetamine-assisted therapy on the severity of PTSD symptoms in participants aged 18 years and older with PTSD of at least moderate severity.
CONDITIONS
Official Title
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet DSM-5 criteria for current PTSD with symptoms lasting at least 6 months at screening
- Fluent in English for speaking and reading
- Veteran enrolled at a VA Healthcare Center in Greater Los Angeles
- Able to swallow pills
- Agree to have study visits audiovisually recorded
- Able to provide a contact person reachable if participant becomes unwell or unreachable
- Able to identify support person(s) to stay with participant on experimental session evenings
- May have well-controlled hypertension if cleared by additional screening
- May have asymptomatic Hepatitis C virus if previously evaluated and treated as needed
- Body weight at least 45 kg; if 45-48 kg, BMI must be between 18 and 30 kg/m2; otherwise BMI must be 18 to 32 kg/m2 inclusive
- Persons able to become pregnant must use a highly effective contraceptive method
You will not qualify if you...
- Unable to give adequate informed consent
- History or evidence of significant medical or psychiatric disorders
- Abusing illegal drugs
- Unable or unwilling to safely taper off prohibited psychiatric medication
- Currently enrolled in another clinical study involving investigational treatment or medical research without study clinician approval
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
VA Greater Los Angeles Healthcare System, Westwood campus
Los Angeles, California, United States, 90073
Not Yet Recruiting
2
West Los Angeles Veteran Affairs
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
S
Stephanie L Taylor, PhD
CONTACT
S
Stephen Marder, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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