MDMA for AUD/PTSD Comorbidity

NCT05943665 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY00000023
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Alcohol Use Disorder; Post Traumatic Stress Disorder

Keywords

AUD; PTSD

Outcome Measures

Primary Outcomes (2)

• Number of standard unit drinks form the TLFB

  Amount of alcohol consumed

  From baseline to post-treatment follow up (18 weeks)

• CAPS score reduction

  Severity score past 30 days

  From baseline to post-treatment follow up (18 weeks)

Secondary Outcomes (2)

• Safety and tolerability

  From baseline to post-treatment follow up (18 weeks)

• Safety and tolerability

  From baseline to post-treatment follow up (18 weeks)

Study Arms (1)

MDMA-AT

EXPERIMENTAL

Participant will receive MDMA administration with assisted therapy (AT) by trained clinicians

Drug: MDMA

Interventions

MDMA DRUG

medication and therapy combined

Also known as: Assisted Therapy (AT)

MDMA-AT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are able to provide proof of veteran status.
• Are fluent in speaking and reading English.
• At Baseline, meet criteria for Alcohol Use Disorder as measured by the SCID-5.
• Able to safely abstain from alcohol for at least 48 hours without requiring medical detox.
• At Baseline meet DSM-5 criteria for current PTSD with a symptom duration of at least 6 months.
• At Baseline, have a PCL-5 score of 33 or greater.
• At Baseline, have a confirmed PTSD diagnosis per the CAPS-5 and a Total Severity Score of 28 or greater.
• Are able to swallow pills.
• Agree to have study visits recorded, including Experimental Sessions, 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 a participant becoming unwell or unreachable.
• Able to identify appropriate support person(s) to stay with the participant on the evenings of the Experimental Sessions, see Section Support Person.
• Weight
• Body weight of at least 45 kilograms (kg). Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2.
• Sex and Contraceptive/ Barrier Requirements
• For participants assigned female sex at birth:

You may not qualify if:

• Medical Conditions
• Have symptomatic liver disease or have significant liver enzyme elevations.
• Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 x upper limit of normal (ULN).
• Total bilirubin \> 1.5 x ULN or direct bilirubin \< 35%.
• 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.
• Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.
• Have a history of seizures or delirium tremens (DTs).
• Significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment of alcohol scale, revised (CIWA-Ar) \>10.
• Have a recent history of clinically significant hyponatremia or hyperthermia.
• Have a marked Baseline QTcF interval \>450 ms demonstrated on repeated ECG assessments. Participants whose QTcF exceeds this value during screening may be initially enrolled if a pre-study concomitant medication is suspected to be prolonging the QT-interval. ECGs should be repeated after initial enrollment and tapering off the pre-study concomitant medication to ensure the participant meets eligibility criteria prior to enrollment confirmation and to IMP dosing.
• Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read.
• Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.
• 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.
• 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.
• Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.

Sponsors & Collaborators

• Carolina L Haass-Koffler: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

RECRUITING

Related Publications (1)

• Eaton E, Capone C, Gully BJ, Brown ZE, Monnig M, Worden MS, Swift RM, Haass-Koffler CL. Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 20;41:101333. doi: 10.1016/j.conctc.2024.101333. eCollection 2024 Oct.

  PMID: 39262902 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

Christy Capone, PhD

CONTACT

401-273-7100; christy_capone@brown.edu

Erica Eaton, PhD

CONTACT

401-273-7100; erica_eaton@brown.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: February 6, 2024
• Primary Completion: January 21, 2026
• Study Completion: January 30, 2026
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (1)