Group MDMA-therapy for Veterans With PTSD (Group-MVP)
This open-label, non-randomized Phase IIa trial (n=18) evaluates the feasibility and safety of MDMA-assisted group therapy for treating PTSD in veterans. Conducted by the Portland VA Research Foundation, the study employs a unique treatment package comprising two once-monthly open-label MDMA sessions combined with non-drug preparatory and integrative therapy, both individual and group-based.
Detailed Description
This Phase 2a, open-label, non-randomized, three-cohort study assesses feasibility and safety of MDMA-assisted group therapy for veterans with at least moderate PTSD; up to 18 participants are recruited in three cohorts of six.
Treatment comprises four preparatory sessions, two once-monthly MDMA sessions (120 mg with optional 60 mg supplemental at 1.5–2 hours), and integrative individual and group therapy; primary outcome is CAPS-5 assessed by a blinded independent rater pool.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
MDMA-assisted group therapy
experimentalFour preparatory sessions, two MDMA sessions, and integrative group/individual therapy (manualized)
Interventions
- MDMA120 mgvia Oral• two sessions• 2 doses total
Initial 120 mg MDMA HCl with optional 60 mg supplemental dose at 1.5–2 hours; sessions monthly
- Compoundvia Other• ongoing
Manualized group psychotherapy plus non-directive individual MDMA-assisted therapy; preparatory and integrative sessions
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 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
- 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.