A study into the safety and effects of... — Clinical Trial Details

Open-label lead-in Phase 2 study evaluating safety and effect of manualized MDMA-assisted psychotherapy for severe PTSD at sites planned for Phase 3; participants receive non-drug preparatory and integrative psychotherapy plus three experimental MDMA-assisted sessions.

Each Experimental Session uses a flexible oral MDMA regimen (initial 80 or 120 mg with a supplemental half-dose of 40 or 60 mg 1.5–2 hours later; total per session 80–180 mg) and outcomes include change in CAPS-5 from baseline to 18 weeks, safety assessments (AEs, SAEs, vitals) and central independent rater evaluation.

The study aims to gather supportive safety/effect data and provide clinical supervision to therapy teams ahead of planned Phase 3 trials.

Participants

Ages

18 – 99

Sexes

Male & Female

BMI

Psychosis History

Inclusion Criteria

At completion of Screening, participants must meet eligibility (except Inclusion Criterion #13) and agree to lifestyle modifications and study procedures. Enrollment confirmed after Preparatory Period, medication tapering if needed, and confirmed PTSD diagnosis per CAPS-5 with Total Severity Score ≥35. Eligible participants must: 1) be ≥18 years; 2) be fluent in the site language; 3) be able to swallow pills; 4) agree to recording of study visits; 5) provide a contact person reachable if participant becomes suicidal/unreachable; 6) inform investigators within 48 hours of new medical conditions/procedures; 7) if of childbearing potential have negative pregnancy test at entry and prior to each Experimental Session and use adequate contraception through 10 days after last Experimental Session; 8) agree to fasting/medication restrictions, not to enrol in other interventional trials during study, remain overnight after Experimental Sessions and be driven home, and commit to medication dosing, therapy, and procedures. Medical: 9) meet DSM-5 criteria for current PTSD ≥6 months; 10) PCL-5 total score ≥50 in last month; 11) may have well-controlled hypertension if screened for cardiovascular disease; 12) may have asymptomatic treated HCV; 13) at Baseline have CAPS-5 Total Severity Score ≥35.

Exclusion Criteria

1) Unable to give adequate informed consent; 2) engaged in compensation litigation related to PTSD or other psychiatric disorders; 3) likely to be re-exposed to index trauma, lack social support, or lack stable living situation; 4) ecstasy/MDMA use >10 times in past 10 years or any use within 6 months of first Experimental Session, or prior participation in MAPS-sponsored MDMA trials; 5) any current problem judged by investigator to interfere with participation. Psychiatric: 6) ECT within 12 weeks of enrollment; 7) history of or current primary psychotic disorder, bipolar I, or dissociative identity disorder; 8) current eating disorder with active purging; 9) current major depressive disorder with psychotic features; 10) active substance use disorder (except caffeine/nicotine) in past 60 days; 11) current personality disorder as assessed via SCID-5-PD; 12) current serious suicide risk (exclusion) though history of suicide attempts is not exclusion; 13) would present serious risk to others; 14) require ongoing concomitant psychiatric medication except as allowed. Medical: 15) significant medical disorders increasing MDMA risk (including seizure disorder); 16) uncontrolled hypertension (≥140/90 mmHg on three occasions); 17) marked QT/QTc prolongation (repeated QTc >450 ms Bazett); 18) additional risk factors for Torsades de pointes; 19) use of medications that prolong QT/QTc during Experimental Sessions; 20) symptomatic liver disease; 21) history of hyponatraemia or hyperthermia; 22) weight <48 kg; 23) pregnant or nursing or of childbearing potential not using effective contraception.

Company

Product

Legal

A study into the safety and effects of psychotherapy in combination with MDMA as a treatment for severe post-traumatic stress disorder

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

MDMA-assisted psychotherapy

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details