Methylenedioxymethamphetamine (MDMA) trial

Brief outline of the study

This study is a randomised controlled trial to test a 14-week program of MDMA-assisted therapy compared to a waitlist controlled condition. Treatment comprises 12 psychotherapy sessions and two dosing sessions using 3,4-methylenedioxymethamphetamine. Participants will be supported throughout by two qualified mental health professionals (therapist dyad) for the duration of treatment.

The two dosing sessions will be spaced four weeks apart, using an initial dose of 120mg followed by a supplementary 40mg dose 1.5 hours later, unless contraindicated. Each session will last approx. 8 hours with two trial therapists providing support throughout.

Participants will also attend 12 psychotherapy sessions. These include three weekly preparatory sessions before the first dose, three integration sessions following the first dose, and six integration sessions following the second dose. Preparatory psychotherapy will include a range of approaches supporting safe and effective dosing sessions, and integrative psychotherapy will include a range of approaches supporting sustained outcomes. All psychotherapy sessions will run for 90 minutes and provide support relevant to PTSD symptoms and psychedelic experience.

Research area

Clinical Sciences / Psychiatry

Inclusion criteria

Participants must be:

  • 18-75 Years old
  • proficient in English
  • Military veteran or First Responder
  • diagnosed with PTSD
  • residing in Victoria

Other details

  • Do you have advertising approval: Yes
  • Study approved by: Monash Health
  • Ethics Committee Project Number - 37226
  • Recruitment start date - September 2023
  • Recruitment end date - Jun 2025
  • Website link
  • Principal Investigator: DR Paul Liknaitzky, Head, Clinical Psychedelic Lab
  • Type of study: Interventional Clinical Trial
  • Pharmaceutical/sponsored: Monash University

Contact

Sarah-Jane Brighthope, Research Officer |E: Sarah-Jane.Brighthope@monash.edu