Clinical TrialMDMARecruiting

Safety and efficacy of MDMA-assisted therapy for Post-Traumatic Stress Disorder in Military Veterans and First Responders: a randomised waitlist-controlled clinical trial [MMP-1]

This randomised controlled parallel group Phase II trial (n=24) evaluated the safety and efficacy of mdma for post-traumatic stress disorder.

Target Enrollment
24 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

This clinical trial will investigate the safety and efficacy of a 14-week MDMA assisted psychotherapy treatment for PTSD. The primary outcome measure will assess clinician-rated changes in PTSD severity, alongside a range of secondary and exploratory measures assessing functional impairment associated with PTSD, quality of life, relationships to adverse childhood experiences, and changes in comorbid psychiatric symptoms. Safety outcome measures will also investigate the safety and tolerability of the drug.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • MDMA

Participants

Inclusion Criteria

  • Adults with current diagnosis of PTSD.
  • Military veteran or first responder
  • Proficiency in English.
  • Availability of appropriate Support Person (relative, spouse, close friend) who can transport and provide basic support to participants following the dosing sessions.
  • Ability to discontinue certain excluded medications if deemed safe, appropriate, agreeable; if discontinuation can occur under guidance of prescribing doctor. (Note, prospective participants are not required to discontinue any medications prior to written confirmation of their enrolment into the study).
  • Agree to all study-related requirements.

Exclusion Criteria

  • Any CNS disorders
  • Current or past history of meeting DSM-5 criteria for certain excluded psychiatric indications.
  • Have history of any medical condition that could make receiving a sympathomimetic drug harmful, or have any relevant cardiovascular conditions
  • Diagnosis of epilepsy or previous seizures
  • Major liver, kidney, thyroid abnormalities
  • Insulin-dependent diabetes (unless well-managed)
  • Pregnant, nursing, trying to conceive
  • Taking, and inappropriate to discontinue, excluded medications, including SSRIs, SNRIs, potent metabolic inducers or inhibitors.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2023-11-10
    End: 2025-03-01
  • Compound
    MDMA

Locations

Unknown facility — Australia

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