MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder (NCT05790239) | Clinical Trial Compass
RecruitingPhase 2
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
United States40 participantsStarted 2025-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
* Fluent in speaking and reading the predominantly used or recognized language of the study site (English).
* Must be a veteran enrolled at a VA Healthcare Center in the Greater Los Angeles area.
* Able to swallow pills.
* Agree to have study visits audiovisually recorded, including Experimental Sessions, IR assessments, and non-drug therapy sessions.
* Able to provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of the participant becoming unwell or unreachable.
* Able to identify appropriate support person(s) to stay with the participant on the evenings of Experimental Sessions if needed.
* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
* Body weight of at least 45 kilograms (kg). Participants with a body weight of 45-48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2. BMI must be within 18 to 32 kg/m2 (inclusive).
* A person able to be pregnant (PABP) must use a highly effective contraceptive method.
Exclusion Criteria:
* Are not able to give adequate informed consent.
* Have evide…
What they're measuring
1
Compare changes in PTSD symptom severity in the MDMA vs active control group.
Timeframe: Visit 17 (approximately 14 weeks after enrollment)