Actively Recruiting
MDMA for AUD/PTSD Comorbidity
Led by Carolina L Haass-Koffler · Updated on 2025-02-10
18
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.
CONDITIONS
Official Title
MDMA for AUD/PTSD Comorbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide proof of veteran status
- Fluent in speaking and reading English
- Meet criteria for Alcohol Use Disorder at baseline as measured by SCID-5
- Able to safely abstain from alcohol for at least 48 hours without medical detox
- Meet DSM-5 criteria for current PTSD with symptoms lasting at least 6 months
- Have a PCL-5 score of 33 or greater at baseline
- Confirmed PTSD diagnosis with CAPS-5 Total Severity Score of 28 or greater at baseline
- Able to swallow pills
- Agree to have study visits and therapy sessions recorded
- Able to provide a contact person reachable by investigators if needed
- Able to identify support person(s) to stay with participant on evenings of Experimental Sessions
- Body weight of at least 45 kilograms; if 45 to 48 kg, BMI must be between 18 and 30 kg/m2
- For participants assigned female sex at birth: not pregnant, not breastfeeding, and either unable to become pregnant or using a highly effective contraceptive method with negative pregnancy tests
- Capable of giving signed informed consent
- Agree to inform investigators within 48 hours of any medical conditions or procedures
- May have asymptomatic Hepatitis C if evaluated and treated as needed
- Must have a realistic plan to reduce substance use and manage symptoms without self-medicating
- May have stable Diabetes Mellitus (Type 2) if cardiovascular disease is ruled out and approved by study clinician
- May have hypothyroidism if on stable thyroid medication
- May have glaucoma if approved by an ophthalmologist
You will not qualify if you...
- Have symptomatic liver disease or significant liver enzyme elevations (ALT or AST >3x upper limit of normal, total bilirubin >1.5x upper limit, or direct bilirubin <35%)
- Current unstable liver or biliary disease (ascites, encephalopathy, coagulopathy, hypoalbuminemia, varices, jaundice, cirrhosis)
- History of seizures or delirium tremens
- Significant alcohol withdrawal symptoms (CIWA-Ar >10)
- Recent clinically significant hyponatremia or hyperthermia
- Marked QTcF interval >450 ms on repeated ECG assessments
- History of medical conditions harmful for sympathomimetic drugs such as myocardial infarction, stroke, heart failure, severe coronary artery disease, aneurysm
- Diagnosis of controlled or uncontrolled hypertension (≥140/90 mmHg)
- History of ventricular arrhythmia except occasional PVCs without ischemic heart disease
- Wolff-Parkinson-White syndrome or untreated accessory pathways
- History of arrhythmia within 12 months unless successfully treated or stable
- Additional risk factors for Torsade de pointes (heart failure, hypokalemia, family history of Long QT Syndrome)
- MRI exclusion criteria: non-removable ferromagnetic materials, claustrophobia, head trauma history
- Recent new psychiatric care including ECT or ketamine therapy within 12 weeks
- Current use of antidepressants requiring taper or antipsychotics
- Likely re-exposure to trauma during study
- Moderate or severe cannabis use disorder within 12 months
- Active substance use disorder (other than mild or early remission cannabis) within 12 months
- Use of Ecstasy more than 10 times in last 10 years or within 6 months prior to first session
- Serious suicide risk or recent suicidal behavior
- Risk to others as determined clinically
- Need for ongoing psychiatric medications except SSRIs approved for taper
- Current use of pharmacotherapies for alcohol use (naltrexone, disulfiram)
- Use of medications that prolong QT interval during sessions
- Engaged in trauma-focused psychotherapy or treatment program for substance use disorder
- Enrollment in other clinical studies unless approved
- History or current primary psychotic disorder, bipolar I, or dissociative identity disorder
- Current eating disorder with compensatory behaviors
- Current major depressive disorder with psychotic features
- Current personality disorders as assessed
- Unable to provide informed consent
- Sensitivity or allergy to study interventions
- Engaged in compensation litigation for PTSD or psychiatric disorders
- Lack of social support or stable living situation
- Previous participation in MAPS MDMA clinical trials
- Employees or immediate family of MAPS or related entities
- Any other problem interfering with participation as judged by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Brown University
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
C
Christy Capone, PhD
CONTACT
E
Erica Eaton, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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