MDMA therapy for veterans with PTSD
Official title: A Randomized, Double-Blind, Single-Site Phase II 2-Arm Study to Compare the Safety and Preliminary Efficacy of Manualized MDMA-Assisted Therapy to Low Dose D-Amphetamine Assisted Therapy in Veterans For The Treatment of Moderate to Severe PTSD
Run by VA Greater Los Angeles Healthcare System · NCT05790239 · Data updated 2026-11-12
This study is testing whether MDMA therapy can help veterans with moderate to severe PTSD feel better compared to a low dose of d-amphetamine therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | VA Greater Los Angeles Healthcare System Federal |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | March 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT05790239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are veterans aged 18 and older with a diagnosis of moderate to severe PTSD lasting at least six months.
✕Probably not a fit
Patients who do not meet the PTSD criteria or are not veterans enrolled at a VA Healthcare Center may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial investigates the safety and preliminary efficacy of MDMA-assisted therapy compared to low dose d-amphetamine-assisted therapy for treating moderate to severe PTSD symptoms in veterans. The study involves a randomized, double-blind design with 40 participants from the Greater Los Angeles VA, who will undergo a series of preparatory and treatment sessions, including assessments of PTSD severity using the CAPS-5 scale. Participants will receive either MDMA or d-amphetamine during the experimental sessions, followed by integrative therapy sessions to support their recovery.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce PTSD symptoms in veterans, improving their quality of life.
How similar studies have gone: Previous studies have shown promising results with MDMA-assisted therapy for PTSD, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
West Los Angeles Veteran Affairs
Los Angeles, California, United States Recruiting -
VA Greater Los Angeles Healthcare System, Westwood campus
Los Angeles, California, United States Not yet recruiting
Study contacts
- Principal investigator: Stephen Marder, MD — VA Greater Los Angeles Healthcare System
- Study coordinator: Stephanie L Taylor, PhD
- Email: Stephanie.Taylor8@va.gov
- Phone: 213-505-1140
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MDMA Therapy for PTSD in Veterans
This phase 2 study tests a fixed 120 mg dose of MDMA, followed by a 60 mg supplemental dose, plus therapy, to see if it helps adults who are veterans with PTSD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.