A Randomised, Double-Blind, Active Placebo-Controlled Phase 2 Pilot Study of MDMA-Assisted Manualised Psychotherapy in Australian War Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD)

This double-blind, placebo-controlled Phase II pilot study (n=14) investigates the safety and efficacy of MDMA-assisted manualised psychotherapy (30-125mg) in Australian war veterans with chronic, treatment-resistant posttraumatic stress disorder (PTSD).

The trial, registered on ANZCTR (ACTRN12612000219886), includes an open-label lead-in for two participants, receiving two experimental drug-assisted psychotherapy sessions using 125mg MDMA with an optional supplemental dose of 62.5mg. This lead-in aims to verify therapist adherence to the psychotherapy manual.

The subsequent double-blinded Stage 1 compares 125mg MDMA to a 30mg MDMA active placebo in 12 participants. Stage 2, an optional treatment for active placebo recipients, involves open-label full-dose MDMA-assisted psychotherapy.

The study, conducted in Australia, encompasses 12 sessions over six months, combining drug-assisted and non-drug psychotherapy. Primary outcomes include changes in PTSD symptoms measured by the Global Clinician-Administered PTSD Scale (CAPS) scores, with additional assessments for depression, quality of life, sleep quality, general well-being, and PTSD diagnostic scale.

Ethical approval is pending, and the study is funded by Psychedelic Research in Science & Medicine Inc and the Multidisciplinary Association for Psychedelic Studies, with Dr. Stuart Saker as the principal investigator. The trial was registered on 21/02/2012, with a submission date of 16/02/2012, and is expected to run from January 2023 to October 2024.

Topic PTSD Depression
Compound MDMA
Country Australia
Visit trial
Status Unknown status
Results Published No
Start date 16 February 2012
End date 12 November 2015
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 14
Sex All
Age 18- 65
Therapy Yes

Trial Details

This research study employs a two-arm, randomised, multi-dose design with an open-label lead-in for two participants, involving two experimental drug-assisted psychotherapy sessions using MDMA. The lead-in aims to ensure therapist adherence to the psychotherapy manual. Stage 1, a double-blinded phase, compares the therapeutic effects of 125mg MDMA to a 30mg MDMA active placebo in 12 participants. Both groups undergo two drug-assisted psychotherapy sessions and 10 non-drug psychotherapy sessions, following the lead-in schedule. Stage 2 is an optional treatment for those who received the active placebo in Stage 1, involving open-label full-dose treatment and additional psychotherapy sessions. All participants undergo a long-term follow-up session 12 months after their final drug-assisted session. The entire study spans six months with a total of 12 psychotherapy sessions for each participant, blending drug-assisted and non-drug sessions.

Trial Number ACTRN12612000219886

Sponsors & Collaborators

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

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.