Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (MPG1)
This Phase II, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans
Detailed Description
Phase 2 open-label study testing two once-monthly MDMA-assisted group therapy sessions (120 mg initial with optional 60 mg supplemental 1.5–2 hours later) combined with preparatory and integrative non-drug therapy in veterans with moderate or greater PTSD.
Primary outcome is change in CAPS-5 assessed by a blinded independent rater pool; feasibility and safety assessed through adverse events, vitals, and study retention across three cohorts.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted therapy
experimentalTwo once-monthly experimental MDMA-assisted group therapy sessions with divided-dose MDMA and accompanying preparatory/integrative non-drug therapy.
Interventions
- MDMA120 mgvia Oral• two sessions• 2 doses total
Initial 120 mg with optional supplemental 60 mg 1.5–2 hours later (divided-dose) per session.
Participants
Inclusion Criteria
- 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 Experimental 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.
- Have a current PTSD diagnosis at the time of screening.
Exclusion Criteria
- 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.
- Have an active illicit drug or prescription drug substance use disorder