An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians

The trial (n=4) aims to determine whether an Australian treatment team can safely deliver MDMA-assisted psychotherapy to patients with treatment-refractory PTSD.

The study follows the Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted psychotherapy treatment protocol over approximately 12 weeks. The treatment involves 15 psychotherapy sessions administered by male/female co-therapy teams, with three preparation sessions before the first MDMA session. Each MDMA session consists of two doses administered orally in capsules, followed by overnight stays and integrative psychotherapy sessions. Lifestyle modifications are required, and participants must agree to video recording of study visits.

The primary outcome measures include adherence to the treatment protocol and changes in PTSD severity. Secondary outcomes include functional impairment and safety measures such as monitoring heart rate, blood pressure, and suicidality.

The trial, conducted at Edith Cowan University, aims to assess the feasibility of providing MDMA-assisted psychotherapy in Australia. Data sharing will be available upon request, with individual participant data accessible until January 2028.

Topic PTSD
Compound MDMA
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 19 May 2022
End date 01 May 2025
Phase Phase I Phase II
Design Open
Type Interventional
Generation First
Participants 4
Sex All
Age 18- 99
Therapy Yes

Trial Details

The objective of this investigator-initiated study is to determine whether an Australian treatment team can safely and effectively deliver 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with treatment-refractory posttraumatic stress disorder (PTSD) through training and ongoing mentoring from the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a non-profit research and educational organisation working to obtain approval for the prescription use of 3,4-methylenedioxymethamphetamine (MDMA) as an adjunct to psychotherapy in patients with posttraumatic stress disorder (PTSD). It uses an open-label design to assess the feasibility of safely and effectively providing MDMA-assisted psychotherapy in Australia by treating four Western Australian adults with chronic treatment-resistant PTSD.

NCT Number ACTRN12621001078842

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.