Group MDMA-therapy for Veterans With PTSD
This Phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.
Conditions:
🦠 PTSD
🗓️ Study Start (Actual) 1 October 2023
🗓️ Primary Completion (Estimated) 31 July 2025
✅ Study Completion (Estimated) 30 September 2025
👥 Enrollment (Estimated) 18
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Vancouver, Washington, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Are at least 18 years old.
    • * Are a U.S. Military Veteran
    • * Are fluent in speaking and reading the predominantly used or recognized language of the study site.
    • * Are able to swallow pills.
    • * Agree to have study visits recorded, including MDMA Sessions, outcome assessments, and non-drug psychotherapy sessions.
    • * Must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
    • * Must agree to inform the investigators within 48 hours of any medical conditions and procedures.
    • * If able to become pregnant, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate contraception through 10 days after the last Experimental Session.
    • * Must not participate in any other interventional clinical trials during the duration of the study.
    • * Must commit to medication dosing, therapy, and study procedures.
    • * Have a current PTSD diagnosis at the time of screening.

    Exclusion Criteria:

    • * Are not able to give adequate informed consent.
    • * Have uncontrolled hypertension.
    • * Have a marked baseline QTcF interval \>450 milliseconds \[ms\] demonstrated on repeated ECG assessments.
    • * Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
    • * Have evidence or history of significant medical disorders.
    • * Have symptomatic liver or biliary disease.
    • * Have history of hyponatremia or hyperthermia.
    • * Weigh less than 48 kilograms (kg).
    • * Are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control.
    • * Are abusing illegal drugs or alcohol.
Ages Eligible for Study: 18 Years to 64 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 July 2023
  • First Submitted that Met QC Criteria 17 July 2023
  • First Posted 27 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 15 November 2023
  • Last Update Posted 18 November 2023
  • Last Verified November 2023