Clinical TrialPTSDMDMACompleted

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

This multi-site, open-label, Phase II, 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).

Target Enrollment
4 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label Phase II lead-in trial tests whether three sessions of MDMA-assisted psychotherapy reduce PTSD symptoms in participants with at least severe PTSD; therapy teams are being trained for planned Phase III studies.

Participants receive three preparatory non-drug sessions, three experimental MDMA-assisted therapy sessions (flexible MDMA dosing 100–125 mg with optional supplemental half-dose 1.5–2 hours later; total per session 100–187.5 mg), and three integrative non-drug sessions after each Experimental Session; primary outcome is change in CAPS-5 from baseline to Visit 19.

Study Protocol

Preparation

3 sessions

Dosing

3 sessions

Integration

9 sessions

Therapeutic Protocol

support

Study Arms & Interventions

MDMA-assisted therapy

experimental

Three open-label sessions of MDMA-assisted psychotherapy with manualized non-directive therapy; flexible MDMA dosing with optional supplemental half-dose.

Interventions

  • MDMA100 - 187.5 mg
    via Oral• three sessions• 3 doses total

    Initial dose 100–125 mg with optional supplemental half-dose 1.5–2 h later; total per session 100–187.5 mg.

  • Compound
    via Other• treatment period• 1 doses total

    Manualized non-directive psychotherapy (3 preparatory sessions, 3 integrative sessions after each Experimental Session).

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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.
  • Meet DSM-5 criteria for active substance use disorder for any substance other than caffeine or nicotine
  • Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS or Lykos-sponsored MDMA clinical trial.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment4 participants
  • Timeline
    Start: 2018-10-04
    End: 2019-10-04
  • Compound
    MDMA
  • Topic
    PTSD

Locations

British Columbia Centre on Substance Abuse — Vancouver, British Columbia, Canada
Dr. Simon Amar, LLC — Montreal, Quebec, Canada

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