An open label study to investigate the safety and feasibility of delivering 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy to patients with posttraumatic stress disorder

This single-blind trial (n=15) will investigate the effects of intramuscularly administered 5-MeO-DMT on various aspects of human brain activity and well-being in healthy adults.

The study, conducted by Swinburne University of Technology in Australia and funded by Psychedelic Research in Science & Medicine (PRISM) Ltd, aims to enhance scientific comprehension of 5-MeO-DMT’s impact through psychological, physiological, and biological markers.

Participants, aged between 18 and 40 years, will undergo four dosing days spaced two weeks apart, receiving doses of 3 mg, 6 mg, and 9 mg of 5-MeO-DMT, alongside an inactive placebo. A psychiatrist or medical practitioner will administer the intervention.

The primary outcome will assess the acute and post-acute effects of 5-MeO-DMT on frequency oscillatory power bands via magnetoencephalography (MEG), while secondary outcomes include evaluations of neurobiological activity, emotional regulation, and other psychological factors using various scales and questionnaires.

Recruitment is anticipated to begin in September 2023 in Victoria, Australia. Principal Investigator Prof Susan Rossell can be contacted for further information.

Topic Healthy Subjects
Compound Placebo 5-MeO-DMT
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 September 2023
End date 01 January 2025
Phase Phase I
Design Blinded
Type Interventional
Generation First
Participants 15
Sex All
Age 18- 40
Therapy No

Trial Details

This study aims to improve the scientific understanding of the effects of intramuscularly (IM) administered 5-MeO-DMT on human brain activity as well as other indexes of well-being as assessed through psychological, physiological, and biological markers. Finally, we aim to further our understanding of the tolerability and safety profile as well as dose-dependent effects of different doses of 5-MeO-DMT or placebo administered per intramuscular administration and to uncover its phenomenological characteristics.

NCT Number ACTRN12623000884606

Sponsors & Collaborators

Swinburne University of Technology
Swinburne University of Technology, located in Melbourne, Australia, is known for its focus on innovation, industry engagement, and social inclusion.

PRISM


Data attribution

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