Clinical TrialPTSDMDMACompleted

A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD

This multi-site open-label study assesses the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy in participants who were enrolled in a parent study for the treatment of posttraumatic stress disorder (PTSD).

Target Enrollment
87 participants
Study Type
Phase III interventional
Design
Non-randomized

Detailed Description

Open-label, single-group extension enrolling participants from parent Phase 3 MDMA-assisted psychotherapy trials (those who received placebo or were unable to complete parent study); participants receive three preparatory non-drug therapy sessions, three MDMA-assisted Experimental Sessions (~1 month apart), and three integrative non-drug therapy sessions following each Experimental Session.

Experimental Sessions use an initial dose of midomafetamine HCl (80 or 120 mg) followed 1.5–2 hours later by a supplemental dose (40 or 60 mg) when tolerated (total per session 80–180 mg); overnight stay is required for most participants.

Primary endpoint: change from baseline in PCL-5 PTSD Checklist scores. Safety and tolerability will be monitored throughout; the study is conducted across multiple US, Canadian and Israeli sites.

Study Protocol

Preparation

3 sessions

Dosing

3 sessions

Integration

9 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

MDMA-assisted therapy

experimental

Three open-label MDMA-assisted therapy sessions ~1 month apart with preparatory and integrative psychotherapy.

Interventions

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

    Initial dose 80 or 120 mg with supplemental 40 or 60 mg 1.5–2 hours later; total per Experimental Session 80–180 mg.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Were previously enrolled in a parent study and (meet one of the following):
  • 1. At time of unblinding, their treatment assignment was to the placebo arm; or,
  • 2. Did not begin Experimental Sessions due to the COVID-19 global pandemic or other unforeseen circumstances; or
  • 3. Completed fewer than three Experimental Sessions prior to Study Termination due to the COVID-19 global pandemic or other unforeseen circumstances.
  • Are considered in good standing with the study site at which they enrolled in a parent study; if, in the opinion of the investigator, therapy team, and Medical Monitor, the participant was compliant with protocol requirements, even if they were unable to complete all study visits.
  • 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
  • Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions.
  • 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] in males and >460 ms in females corrected by Fridericia 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 recent 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 substance use disorder within 12 months

Study Details

  • Status
    Completed
  • Phase
    Phase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment87 participants
  • Timeline
    Start: 2021-07-01
    End: 2023-03-01
  • Compound
    MDMA
  • Topic
    PTSD

Locations

New School Research — Los Angeles, California, United States
San Francisco Insight and Integration Center — San Francisco, California, United States
UCSF — San Francisco, California, United States
Aguazul-Blue Water Inc. — Boulder, Colorado, United States
Wholeness Center — Fort Collins, Colorado, United States
Ray Worthy Psychiatry — New Orleans, Louisiana, United States
Trauma Research Foundation — Boston, Massachusetts, United States
NYU — 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 - Madison — Madison, Wisconsin, United States
Numinus — Vancouver, British Columbia, Canada
Numinus — Montreal, Quebec, Canada
Beer Yaakov Mental Health Center — Beer Yaaqov, Israel
Tel Hashomer — Tel Aviv, Israel

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