MDMA-Assisted Therapy for Veterans with Alcohol Use Disorder and PTSD
This study is looking at MDMA (a medication) combined with therapy for military veterans who have both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). Researchers want to see if this treatment can help reduce alcohol use and improve PTSD symptoms. You might be able to join if you are a veteran, speak English, have AUD and PTSD, and can safely stop drinking alcohol for at least 48 hours. The study will measure how much alcohol you drink and how your PTSD symptoms change over 18 weeks. The current recruitment status is unclear.
- Study design
- This is an open-label pilot study, meaning everyone knows what treatment they are receiving. It plans to include 18 participants.
- What's involved
- You would have an in-person baseline assessment, potentially undergo brain imaging, participate in two once-monthly MDMA-assisted therapy sessions, and complete follow-up assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your alcohol use and PTSD symptoms will be measured from the start of the study until 18 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05943665
MDMA for AUD/PTSD Comorbidity
Recruiting
PHASE2Ages 18+InterventionalTreatmentCarolina L Haass-KofflerInvestigator-initiated
~18 participants
Updated 2025-02-10 on ClinicalTrials.gov
What's tested:MDMA
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of standard unit drinks form the TLFB
Measured over From baseline to post-treatment follow up (18 weeks)
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesRhode Island1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
A participant is eligible to participate if not pregnant, not planning to become pregnant, or is not breastfeeding and one of the following conditions applies
Is not able to become pregnant
Is a person able to be pregnant (PABP) and using a contraceptive method that is highly effective, with a failure rate of \<1%. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first does of study intervention. A PABP must have a highly sensitive negative urine pregnancy test at study entry and prior to each Experimental Session, see Schedule of Activities. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.
Exclusion
Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 x upper limit of normal (ULN).
Total bilirubin \> 1.5 x ULN or direct bilirubin \< 35%. 2. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Participants with other mild, stable chronic medical problems may be enrolled if the study clinician and principal investigators agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP.
Examples of stable medical conditions that could be allowed include, but are not limited to, Diabetes Mellitus (Type 2), Human Immunodeficiency Virus (HIV) infection, Gastroesophageal Reflux Disease (GERD), hypothyroidism (if taking adequate and stable thyroid replacement medication), glaucoma (if approval for study participation is received from an ophthalmologist). Any medical disorder judged by the investigator to significantly increase the risk of MDMA administration by any mechanism would require exclusion. 8. Have a diagnosis of controlled or uncontrolled hypertension, defined as repeated blood pressure readings of ≥ 140 millimeters of Mercury \[mmHg\] systolic or ≥ 90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated. 9. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease. 10. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation. 11. Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.
Suicidal ideation score of 4 or greater within the last 6 months of the assessment at a frequency of once a week or more
Suicidal ideation score of 5 within the last 6 months of the assessment
Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study clinician. 22. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
What this trial measures
- Number of standard unit drinks form the TLFBFrom baseline to post-treatment follow up (18 weeks)
Amount of alcohol consumed
- CAPS score reductionFrom baseline to post-treatment follow up (18 weeks)
Severity score past 30 days