A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

• Status: Completed
• Trial end date: 2020-08-21
• Target enrollment: 0
• Participant gender: All

Summary

This multi-site double-blind, placebo-controlled randomized Phase 3 study assesses the efficacy and safety of MDMA-assisted therapy versus placebo with therapy in participants diagnosed with at least severe PTSD. The study will be conducted in up to N ≈ 100 participants. Participants will be randomized to receive a flexible dose of MDMA or placebo, followed by a supplemental half-dose, unless contraindicated, during the Treatment Period with manualized therapy 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.

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

Details

• Lead Sponsor: Multidisciplinary Association for Psychedelic Studies
• Treatments: N-Methyl-3,4-methylenedioxyamphetamine

Criteria

Inclusion Criteria:

• 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, meet DSM-5 criteria for current severe PTSD

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