Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD
This open-label, randomized study will assess the comparative effectiveness of two versus three active MDMA-assisted sessions in U.S. military veterans with at least moderate chronic PTSD treated in an outpatient VA treatment clinic (n=26 actual enrollment); MDMA 120 mg + supplemental 60 mg with manualized psychotherapy.
Detailed Description
Open-label, randomized, parallel-group trial comparing two versus three monthly MDMA-assisted psychotherapy sessions (120 mg initial dose with optional 60 mg supplemental) in U.S. military veterans with moderate chronic PTSD; each experimental session is accompanied by manualized psychotherapy.
Protocol includes three preparatory non-drug therapy sessions prior to the first MDMA session and three integrative non-drug therapy sessions after each experimental session; primary outcome is CAPS-5 assessed by a centralized blinded independent rater pool at post-treatment.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Two sessions
active comparatorTwo MDMA-assisted therapy sessions with manualized psychotherapy (2 experimental sessions).
Interventions
- MDMA120 mgvia Oral• monthly• 2 doses total
120 mg initial dose with supplemental 60 mg as tolerated; manualized psychotherapy paired with dosing.
- Compound
Manualized psychotherapy: 3 preparatory sessions prior to first MDMA session and 3 integrative sessions after each experimental session.
Three sessions
active comparatorThree MDMA-assisted therapy sessions with manualized psychotherapy (3 experimental sessions).
Interventions
- MDMA120 mgvia Oral• monthly• 3 doses total
120 mg initial dose with supplemental 60 mg as tolerated; manualized psychotherapy paired with dosing.
- Compound
Manualized psychotherapy: 3 preparatory sessions prior to first MDMA session and 3 integrative sessions after each experimental session.
Participants
Inclusion Criteria
- Inclusion Criteria:
- U.S. military veteran
- Are at least 18 years old.
- 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, Independent Rater assessments, and non-drug psychotherapy sessions.
- Must provide a contact (relative, spouse, close friend or other caregiver) 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 of childbearing potential, must have a negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session.
- Must not participate in any other interventional clinical trials during the duration of the study.
- Must be willing to remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
- At baseline, have moderate PTSD diagnosis.
Exclusion Criteria
- Exclusion Criteria:
- Are not able to give adequate informed consent.
- Have uncontrolled hypertension.
- Have a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 milliseconds [ms] corrected by Bazett's formula).
- 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 disease.
- Have history of hyponatremia or hyperthermia.
- Weigh less than 48 kilograms (kg).
- Are pregnant or nursing, or are of childbearing potential and are not practicing an effective means of birth control.
- Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.