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MDMA-Assisted Therapy for Veterans with PTSD

This study is testing MDMA-assisted therapy compared to d-amphetamine-assisted therapy for veterans with moderate to severe Post Traumatic Stress Disorder (PTSD). Researchers want to see if MDMA (3,4-methylenedioxymethamphetamine) or d-amphetamine can help reduce PTSD symptoms. You might be able to join if you are a veteran, 18 or older, have PTSD for at least 6 months, and are enrolled at a VA Healthcare Center in the Greater Los Angeles area. The main goal is to compare how much PTSD symptoms change in each group after about 14 weeks. The study is currently unclear on its recruitment status.

Study design
This is a Phase II, randomized, double-blind study with 40 participants. It compares two groups: MDMA-assisted therapy and d-amphetamine-assisted therapy.
What's involved
You would go through a screening, preparatory sessions, three treatment sessions with therapy, and follow-up visits. This includes assessments of your PTSD symptoms.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms will be assessed about 14 weeks after you enroll in the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05790239

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Stephen Robert Marder
~40 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:3,4-methylenedioxymethamphetamined-amphetamineTherapy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare changes in PTSD symptom severity in the MDMA vs active control group.
Measured over Visit 17 (approximately 14 weeks after enrollment)

Conditions

Post Traumatic Stress Disorder

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

2 sites across 1 states
California2

Study leadership

  • Stephen Marder, MD · PRINCIPAL_INVESTIGATOR · VA Greater Los Angeles Healthcare System
  • Stephanie L Taylor, PhD · PRINCIPAL_INVESTIGATOR · VA Greater Los Angeles Healthcare System

Who to contact

Stephanie L Taylor, PhD
[email protected]
213-505-1140
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Compare changes in PTSD symptom severity in the MDMA vs active control group.Visit 17 (approximately 14 weeks after enrollment)

    The Primary Outcome measure will be the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score from Baseline to Visit 17, assessed by a blinded study staff rater. The total severity score is a sum of symptom frequency and intensity scores for the subscales B (re-experiencing), C (avoidance) and D (hypervigilance) and ranges from 0 to 136, with higher scores indicating greater severity of PTSD symptoms.