Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05943665

An Open Label, Phase 2, Single-arm Pilot Study of MDMA-assisted Therapy in Veterans With Alcohol Use Disorder and Post-traumatic Stress Disorder

Led by Carolina L Haass-Koffler · Updated on 2025-02-10

18

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an open label pilot trial to study MDMA-assisted therapy (MDMA-AT) in military veterans who have both Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This experimental treatment combines therapy sessions with divided doses of MDMA and includes preparatory and integrative non-drug therapy. The study aims to evaluate changes in alcohol use using the Timeline Follow-back (TLFB) tool and assess changes in PTSD symptoms over time. Participants will receive two monthly sessions where MDMA is administered alongside therapy by clinicians trained specifically for this treatment. Before and after these sessions, participants will undergo assessments and may choose to participate in neuroimaging and biomarker collection to examine brain changes related to the treatment. The study follows a longitudinal design and includes a post-treatment follow-up period. During the study, participants will complete in-person baseline assessments and various evaluations at follow-up visits. These assessments include measuring alcohol consumption, PTSD symptom severity, and monitoring safety and tolerability of the treatment. Some imaging procedures are optional and require medical clearance. The total study duration includes treatment and follow-up over approximately 18 weeks, with ongoing monitoring of participants' symptoms and health.

CONDITIONS

Brief Title

MDMA for AUD/PTSD Comorbidity

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
  • 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 recorded
  • Able to provide a contact person reachable if participant becomes unwell or unreachable
  • Able to identify support persons to stay with participant on experimental session evenings
  • Body weight of at least 45 kg; if 45-48 kg, BMI must be 18 to 30 kg/m2
  • For females at birth: not pregnant, not planning pregnancy, not breastfeeding, or using highly effective contraception as specified
  • Capable of giving signed informed consent
  • Agree to inform investigators within 48 hours of any medical conditions or procedures
  • May have asymptomatic Hepatitis C virus with prior evaluation and treatment
  • Have a plan to reduce substance use and manage symptoms without self-medicating, approved by study team
  • May have Type 2 Diabetes if stable and approved by study clinician
  • May have hypothyroidism if on stable thyroid medication
  • May have glaucoma with ophthalmologist approval
Not Eligible

You will not qualify if you...

  • Symptomatic liver disease or significant liver enzyme elevations
  • Current unstable liver or biliary disease
  • History of seizures or delirium tremens
  • Significant alcohol withdrawal symptoms (CIWA-Ar >10)
  • Recent clinically significant hyponatremia or hyperthermia
  • Marked baseline QTcF interval >450 ms without qualification
  • Medical conditions increasing risk from sympathomimetic drugs (e.g., heart attack, stroke, heart failure)
  • Uncontrolled hypertension (blood pressure ≥140/90 mmHg)
  • History of ventricular arrhythmia except occasional PVCs without ischemic heart disease
  • Wolff-Parkinson-White syndrome or untreated accessory pathway
  • History of recent arrhythmia within 12 months
  • Risk factors for Torsade de pointes
  • MRI exclusions: non-removable ferromagnetic materials, claustrophobia, head trauma history
  • Recent new psychiatric care including ECT or ketamine therapy
  • Current use of antidepressants requiring taper
  • Current use of antipsychotics
  • Likely re-exposure to trauma during study
  • Moderate or severe cannabis use disorder within 12 months
  • Active substance use disorder other than cannabis within 12 months
  • Excessive prior use of ecstasy or recent use within 6 months
  • Serious suicide risk or recent suicidal behavior
  • Serious risk to others
  • Ongoing psychiatric medication therapy not allowed
  • Current use of alcohol pharmacotherapies
  • Medications prolonging QT interval during sessions
  • Engagement in trauma-focused psychotherapy or substance use treatment program
  • Enrollment in other clinical studies without approval
  • 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
  • Certain personality disorders
  • Unable to provide informed consent
  • Sensitivity or allergy to study interventions
  • Engaged in compensation litigation related to PTSD
  • Lack of social support or stable living situation
  • Previous participation in MAPS-sponsored MDMA trial
  • Employment or personal relationship conflicts with study sponsors
  • Any other condition interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 18 weeks

Participants receive MDMA-assisted therapy involving medication and sessions with trained clinicians.

Multiple therapy sessions during treatment period

Follow-up

Duration - Post-treatment follow-up up to 18 weeks from baseline

Participants complete assessments to evaluate effects after treatment ends.

1 follow-up visit

Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 02903

Actively Recruiting

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Research Team

C

Christy Capone, PhD

E

Erica Eaton, PhD

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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Published Research Related To This Trial

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.

Erica Eaton, Christy Capone, Brian J Gully...

https://pubmed.ncbi.nlm.nih.gov/39262902