A Phase 1, Dose-Ranging Study to Assess Safety and Psychoactive Effects of a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation (GH001) in Healthy Volunteers
European Psychiatry June 1, 2022 Johannes T. Reckweg, N. Mason, C. van Leeuwen et al. 3 citations
A vaporized formulation of 5-MeO-DMT, a fast-acting psychedelic, was tested in 22 healthy volunteers at single doses of 6, 12, and 18 mg and with an individualized dose escalation regimen. The drug produced dose-related increases in the intensity of psychedelic experiences, as measured by several questionnaires, except for challenging experiences. Maximal effects on mystical, ego dissolution, and altered states of consciousness ratings occurred after individualized dose escalation. Cognition, mood, and well-being were not affected. Vital signs remained stable, and adverse events were mild and resolved on their own. Individualized dose escalation may be preferable for clinical applications aiming to enhance short-term psychoactive effects for a strong therapeutic response.