Clinical TrialPTSDMDMAPlaceboCompleted

A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1)

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder that can develop after a traumatic life experience that severely reduces the quality of life. This multi-site, double-blind, placebo-controlled, randomized Phase III study assessed the efficacy and safety of MDMA-assisted psychotherapy compared to psychotherapy with placebo in participants diagnosed with at least moderate PTSD.

Target Enrollment
100 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

This randomised, double-blind, parallel-group Phase 3 trial (n≈100) compared MDMA-assisted psychotherapy versus placebo with identical psychotherapy in adults with severe PTSD.

Participants received three preparatory psychotherapy sessions, three experimental sessions (MDMA 80 or 120 mg with a supplemental half-dose 1.5–2 hours later, or placebo), each experimental session followed by three integrative therapy sessions.

Primary outcome is change in CAPS-5 from baseline to 18 weeks; safety assessments include blood pressure, heart rate, body temperature, adverse events and C-SSRS for suicidal ideation/behaviour.

Study Protocol

Preparation

3 sessions

Dosing

3 sessions

Integration

3 sessions

Therapeutic Protocol

maps

Study Arms & Interventions

MDMA-assisted therapy

experimental

Three experimental sessions of MDMA-assisted manualized therapy (plus preparatory and integrative sessions).

Interventions

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

    Initial 80 or 120 mg followed 1.5–2 h later by supplemental half-dose (40 or 60 mg); per-session total 80–180 mg.

Placebo with therapy

placebo

Three experimental sessions of inactive placebo with identical manualized therapy.

Interventions

  • Placebo
    via Oral• three sessions• 3 doses total

    Inactive placebo administered during experimental sessions.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Are at least 18 years old
  • Are fluent in speaking and reading the predominantly used or recognized language of the study site
  • Are able to swallow pills
  • 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
  • At baseline, meet DSM-5 criteria for current severe PTSD

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] in males and >460 ms in females 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, such as myocardial infarction, cerebrovascular accident, or aneurysm
  • 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
  • Have an active illicit or prescription drug use disorder
  • 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-sponsored MDMA clinical trial.

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment100 participants
  • Timeline
    Start: 2018-11-29
    End: 2020-08-21
  • Compounds
    MDMAPlacebo
  • Topic
    PTSD

Locations

New School Research LLT — 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
Ray Worthy Psychiatry LLC — New Orleans, Louisiana, United States
Trauma Research Foundation — Boston, Massachusetts, United States
New York University — New York, New York, United States
New York Private Practice — 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
Providence Health Center — Vancouver, British Columbia, Canada
Dr. Simon Amar, Inc. — Montreal, Quebec, Canada
Assaf Harofeh Research Fund — Be’er Ya‘aqov, Israel
Sheba Fund for Health Services and Research — Tel Litwinsky, Israel

Your Library