MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Recruiting
Phase 2Interventional Study
Post Traumatic Stress Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Stephen Robert Marder · Federal
Who this trial is looking for
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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.
Trial Locations
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Status
Eligibility Criteria
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 Lo…
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 evidence or history of significant medical or psychiatric disorders.
* Are abusing illegal drugs.
* Unable or unwilling to safely taper off prohibited psychiatric medication.
* Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.
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