CompletedPhase 1MDMA
Group MDMA-therapy for Veterans With PTSD
Sponsored by Portland VA Research Foundation, Inc
NCT ID
NCT05961527
Target Enrollment
23 participants
Start Date
2023-10-01
Est. Completion
2025-03-14
About This Study
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 Studied
Interventions
- •MDMA
- •Group Therapy
Eligibility
Age:18 Years - 64 Years
Healthy Volunteers:No
View full eligibility 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: * 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.
Study Locations (1)
Portland-Vancouver VA
Vancouver, Washington, United States