Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Midomafetamine; Therapy
Intervention description: Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later; Non-directive therapy
Intervention MeSH terms: N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label multi-site study axamining safety and effects of three sessions of MDMA-assisted psychotherapy, with Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) severity after treatment compared with baseline
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD; MDMA; Therapy

Summary:

      This multi-site, open-label, Phase 2, lead-in study assesses the safety and effect of
      3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants diagnosed
      with at least severe posttraumatic stress disorder (PTSD). Therapy teams that have been
      identified and trained to work on the sponsor's planned Phase 3 studies will treat at least
      one open-label participant in this study. A flexible dose of MDMA (100 to 125 mg), followed
      by a supplemental half-dose, unless contraindicated, is administered during the Treatment
      Period with manualized therapy in three open-label 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 the Clinician Administered PTSD
      Scale for DSM 5 (CAPS-5) total severity scores from Baseline to Visit 19. The secondary
      outcome measure is the change in the customized version of the Sheehan Disability Scale (SDS)
      for PTSD for the MAPS studies total scores from Baseline to Visit 19.
    

Eligibility 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

          -  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

        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.

          -  Must not be abusing illegal drugs