Clinical TrialPTSDMDMACompleted

Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD

This multi-site, open-label, Phase II lead-in study (n=38) assesses safety and efficacy of three sessions of MDMA-assisted therapy (flexible MDMA dosing 80–120 mg with optional supplemental half-dose) in participants with at least severe PTSD.

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

Detailed Description

Multi-site, open-label, single-group Phase II study evaluating three preparatory psychotherapy sessions, three MDMA-assisted experimental sessions, and integrative psychotherapy following each MDMA session in adults with severe PTSD (n=38).

MDMA dosing per experimental session is flexible (initial 80–120 mg with a 40–60 mg supplemental dose 1.5–2 hours later; total per session 80–180 mg). Primary outcome is change in CAPS-5 from baseline to primary endpoint; safety assessed via AEs, vitals and laboratory measures.

Study Protocol

Preparation

3 sessions

Dosing

3 sessions

Integration

9 sessions

Therapeutic Protocol

support

Study Arms & Interventions

MDMA-assisted therapy

experimental

Three sessions of MDMA-assisted therapy with flexible MDMA dosing (80–120 mg with optional supplemental half-dose).

Interventions

  • MDMA80 - 180 mg
    via Oral• three sessions• 3 doses total

    Initial 80–120 mg with 40–60 mg supplemental 1.5–2 h later; total per session 80–180 mg.

  • Compound
    via Other• three sessions

    Manualized non-directive psychotherapy provided during preparatory, experimental and integrative sessions.

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
  • Meet DSM-5 Criteria for Severe PTSD

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.

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment38 participants
  • Timeline
    Start: 2017-10-24
    End: 2019-08-10
  • Compound
    MDMA
  • Topic
    PTSD

Locations

New School Research LLC — North Hollywood, California, United States
San Francisco Insight and Integration Center — San Francisco, California, United States
University of California San Francisco — San Francisco, California, United States
Aguazul-Blue Water Inc. — Boulder, Colorado, United States
Wholeness Center — Fort Collins, Colorado, United States
University of Connecticut — Farmington, Connecticut, United States
Ray Worthy Psychiatry LLC — New Orleans, Louisiana, United States
Trauma Research Foundation — Brookline, Massachusetts, United States
New York University — New York, New York, United States
Affective Care — New York, New York, United States
Zen Therapeutic Solutions, LLC — Mt. Pleasant, South Carolina, United States
University of Wisconsin at Madison — Madison, Wisconsin, United States

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