Study of Feasibility and Safety of MDMA-Assisted... — Clinical Trial Details

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.

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:
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

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Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans (MPG1)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-assisted therapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details