NCT07118839 · VA Office of Research and Development
MDMA-Assisted Therapy for Veterans With PTSD and Alcohol Use Disorder
What this study is about
The study investigators are conducting the first randomly assigned compared against an inactive treatment trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).
View original scientific description
The study investigators are conducting the first randomized placebo-controlled trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military Veterans with a co-occurring diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of three once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy.
Interventions
DRUG
Full Dose MDMA
During the three Experimental Sessions, participants will receive a split dose of 180 mg midomafetamine hydrochloride salt (MDMA HCl) administered orally (2 × 60 mg midomafetamine HCl capsules, followed approximately 1.5 to 2 hours later by 1 × 60 mg midomafetamine HCl capsule).
BEHAVIORAL
MDMA-Assisted psychotherapy
inner-directive psychotherapy will be conducted throughout the study; Integrative MDMA-Assisted Psychotherapy (IMAP) for PTSD Therapy Manual.
DRUG
Active Placebo Dose MDMA
During the three Experimental Sessions, participants will receive a split dose of 40 mg midomafetamine HCl administered orally (1 × 40 mg midomafetamine HCl capsules and 1 x placebo capsule \[0 mg midomafetamine HCl\], followed 1.5 to 2 hours later by 1 × placebo capsule \[0 mg midomafetamine HCl\]).
Primary outcome measures
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score
Time frame: from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline)
To evaluate the efficacy of MDMA-assisted therapy (MDMA-AT) in reducing PTSD symptom severity in participants with co-occurring PTSD and Alcohol Use Disorder (AUD), as measured by the change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (past 30 days) from Baseline (Visit 3) to Visit 16 (approximately 16 weeks post-baseline). The CAPS-5 total severity score ranges from 0 to 80 with higher scores reflecting worse PTSD symptom severity.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants are eligible to be included in the study if all the following criteria apply: Age 1. Are at least 18 years old at the time of signing the informed consent. Type of Participant and Disease Characteristics 2. Are currently enrolled in VA care. 3. Veterans must have initiated and discontinued (or completed) at least one first-line evidence-based treatment (EBT) for PTSD alone, for PTSD and AUD together, or for a dual-diagnosis condition, as documented in CPRS. 4. Are fluent in speaking and reading English. 5. At Baseline, meet past-year criteria for Alcohol Use Disorder as measured by the SCID-5. 6. Able to safely abstain from alcohol for at least 48 hours without requiring medical detox. 7. At Baseline meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months per the CAPS-5. 8. Are able to swallow pills. 9. Agree to have study visits recorded, including Experimental Sessions, assessments, and non-drug therapy sessions. 10. Able
Where
- West Haven, Connecticut
- Providence, Rhode Island
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations