MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stephen Robert Marder
• Treatments: Amphetamine; Dextroamphetamine; N-Methyl-3,4-methylenedioxyamphetamine

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 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.