This single-blind, non-randomised trial (n=15) aims to explore the effects of intramuscularly administered 5-MeO-DMT (3-9 mg) on human brain activity and well-being indicators.
The study involves 15 healthy volunteers who will receive 5-MeO-DMT at doses of 3 mg, 6 mg, and 9 mg, as well as an inactive placebo over four dosing days, spaced two weeks apart.
The primary outcome will assess the acute and post-acute effects of 5-MeO-DMT on frequency oscillatory power bands via magnetoencephalography (MEG).
Secondary outcomes will include assessments of 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, personality, physical symptoms, occurrence of hallucinogen persisting perception disorder (HPPD), reactivation, adverse psychological effects, resting state cognition, degree of challenge of experience, mystical experience, ego dissolution, acceptance-promoting experience, emotional breakthrough, experiences of love, somatic experiences, and avoidance-promoting experience. The study will also evaluate safety parameters and pharmacokinetics.
The trial, conducted by Swinburne University of Technology in Australia, is expected to commence in September 2023, with a primary focus on safety and efficacy in treating depression.
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.