A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

• Status: Enrolling by invitation
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for treatment of posttraumatic stress disorder (PTSD). The study will be conducted in up to N ≈ 100 participants. Participants will receive a flexible dose of MDMA, followed by a supplemental dose, unless contraindicated, during the Treatment Period with manualized psychotherapy in three monthly Experimental Sessions. This ~12-week Treatment Period is preceded by three Preparatory Sessions. During the Treatment Period, each Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Primary Outcome measure is the change in PTSD Checklist (PCL-5) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) from Visit 3 is assessed at Visit

16. This study will compare the effects of three manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA. Initial doses per Experimental Session include 80 mg or 120 mg of MDMA compounded with mannitol and magnesium stearate alone (mannitol and magnesium stearate), followed 1.5 to 2 hours later by a supplemental dose (40 or 60 mg). Total amounts of MDMA to be administered per Experimental Session range from 80 mg to 180 mg.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies

Criteria

Inclusion Criteria:

• Were previously enrolled in a parent study and (meet one of the following):

1. At time of unblinding, their treatment assignment was to the placebo arm; or,

2. Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances;

3. Completed fewer than three Experimental Sessions prior to Study Termination due to the COVID-19 global pandemic or other unforeseen circumstances.

• Are considered in good standing with the study site at which they enrolled in a parent study; if, in the opinion of the investigator, therapy team, and Medical Monitor, the participant was compliant with protocol requirements, even if they were unable to complete all study visits.

• 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

• Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions.

• 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.

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

• Are abusing illegal drugs