This single-blind study aims to investigate the effects of intramuscularly (IM) administered 5-MeO-DMT on various aspects of human brain activity and well-being in healthy adults.
The trial, conducted by Swinburne University of Technology in Hawthorn, Australia, has been approved by the Swinburne University Human Research Ethics Committee. The study will involve 15 healthy volunteers aged between 18 and 40 years, with a good command of English and prior experience with psychedelics without adverse events.
Participants will undergo four dosing days, each spaced two weeks apart, involving IM administration of 5-MeO-DMT at doses of 3 mg, 6 mg, and 9 mg, as well as an inactive placebo.
The primary outcome will assess the acute and post-acute effects of 5-MeO-DMT on frequency oscillatory power bands using magnetoencephalography (MEG).
Secondary outcomes include assessing neurobiological activity, emotional regulation, decentering, suggestibility, social desirability, resilience, interoceptive awareness, satisfaction with life, symptoms of depression, anxiety and stress, mindfulness, self-regulation, spiritual bypassing, somatic symptoms, sleep measures, gratitude, personality, physical symptoms, occurrence of hallucinogen persisting perception disorder (HPPD), reactivation, adverse psychological effects, resting state cognition, challenge of experience, mystical experience, ego dissolution, acceptance promoting experience, emotional breakthrough, experiences of love, somatic experiences, avoidance-promoting experience, safety profile, and a range of sleep measures.
Data collection will occur at baseline, 3 days after each dosing session, then at 1 month and 3 months post-completion of the IM administration series. The study’s principal investigator is Prof Susan Rossell, who can be contacted for further information. The trial is not yet recruiting participants as of February 2024.
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 TechnologySwinburne University of Technology, located in Melbourne, Australia, is known for its focus on innovation, industry engagement, and social inclusion.