Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 2, Open Label study will provide supportive data on the safety and effectiveness of MDMA-assisted therapy in participants with posttraumatic stress disorder (PTSD). This study will be conducted at a single study site in Vancouver, BC. There will be at least 2 co-therapy pairs. The study will enroll up to 20 participants

The Preparatory Period will consist of three 90-minute non-drug Preparatory Sessions. A flexible divided dose of MDMA, will be administered during the Treatment Period with manualized therapy in up to two open-label Study Drug Sessions. During the Treatment Period, each Study Drug Session is followed by three 90-minute Integrative Sessions of non-drug therapy. The Study Drug Sessions are scheduled roughly 3 to 5 weeks apart.

• Phase: Phase 2
• 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 a recognized language of the study site.

• Are able to swallow pills.

• Agree to have study visits recorded, including Study Drug Sessions and non-drug therapy sessions.

• Must provide a contact (relative, spouse, close friend, or other support person) 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, and commit to medication dosing, therapy, and study procedures.

• At baseline, have moderate PTSD diagnosis.

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.