DataSheet1_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.docx
Figshare November 25, 2021 Johannes Reckweg (11755736), Natasha L. Mason (11755739), Cees van Leeuwen (255734) et al.
A vaporized formulation of 5-MeO-DMT (GH001) was tested in 22 healthy volunteers at single doses of 2, 6, 12, and 18 mg, and in an individualized dose escalation regimen. Higher doses produced significantly stronger psychedelic effects on peak experience, mystical experience, ego dissolution, and altered states of consciousness compared to the lowest 2 mg dose, except for challenging experiences. Individualized dose escalation produced the strongest effects. Cognition, mood, and well-being were not affected. Vital signs remained stable, and adverse events were mild and resolved spontaneously. Individualized dose escalation may be preferable for maximizing the experience in clinical applications.