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
In a phase 1 dose-ranging study in 22 healthy volunteers, inhaled GH001 (5‑MeO‑DMT) was well tolerated and produced dose-related increases in psychedelic intensity, with individualized dose escalation yielding the largest mystical and ego‑dissolution effects (PES, MEQ, EDI, 5D‑ASC) while cognition, mood, well‑being, vitals and adverse events remained largely unaffected or mild. These findings indicate individualized dose escalation may be preferable to single fixed doses when aiming to maximise therapeutic psychedelic experiences.
Authors
- Johannes Ramaekers
- Nathalie Mason
- Jan Reckweg
Published
Abstract
5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) is a tryptamine with ultra-rapid onset and short duration of psychedelic effects. Prospective studies for other tryptamines have suggested beneficial effects on mental health outcomes. In preparation for a study in patients with depression, the present study GH001-HV-101 aimed to assess the impact of four different dose levels of a novel vaporized 5-MeO-DMT formulation (GH001) administered via inhalation as single doses of 2 (N = 4), 6 (N = 6), 12 (N = 4) and 18 mg (N = 4), and in an individualized dose escalation regimen (N = 4) on the safety, tolerability, and the dose-related psychoactive effects in healthy volunteers (N = 22). The psychedelic experience was assessed with a novel Peak Experience Scale (PES), the Mystical Experience Questionnaire (MEQ), the Ego Dissolution Inventory (EDI), the Challenging Experience Questionnaire (CEQ), and the 5-Dimensional Altered States of Consciousness Questionnaire (5D-ASC). Further aims were to assess the impact of 5-MeO-DMT on cognitive functioning, mood, and well-being. Higher doses of 5-MeO-DMT produced significant increments in the intensity of the psychedelic experience ratings as compared to the lowest 2 mg dose on all questionnaires, except the CEQ. Prominent effects were observed following single doses of 6, 12, and 18 mg on PES and MEQ ratings, while maximal effects on PES, MEQ, EDI, and 5D-ASC ratings were observed following individualized dose escalation of 5-MeO-DMT. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Vital signs at 1 and 3 h after administration were not affected and adverse events were generally mild and resolved spontaneously. Individualized dose escalation of 5-MeO-DMT may be preferable over single dose administration for clinical applications that aim to maximize the experience to elicit a strong therapeutic response.
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Study Details
- Study Typeindividual
- Journal
- Compounds
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- APA Citation
Reckweg, J., Mason, N. L., van Leeuwen, C., Toennes, S. W., Terwey, T. H., & Ramaekers, J. G. (2021). 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. Frontiers in Pharmacology, 12. https://doi.org/10.3389/fphar.2021.760671
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