Pharmacokinetics of GH001 in Healthy Volunteers

The primary objective of this study is to investigate the serum pharmacokinetics of 5-MeO-DMT and its metabolite, bufotenine in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, inhaled doses of GH001 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH001.

As a secondary objective, the safety and tolerability of GH001, the mental health and well-being of the subjects after GH001 dosing(s), the pharmacodynamic profile of GH001 as evaluated by its psychoactive effects, and cognitive measures are also assessed.

Topic Healthy Subjects
Compound 5-MeO-DMT Placebo
Country Ireland
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Trial Details



Trial Number

Sponsors & Collaborators

GH Research
GH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.

Papers

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT
This data analysis of three studies (n=84) validates a three-item Peak Experience Scale (PES) for rapidly assessing 5-MeO-DMT experiences, demonstrating that the scale shows strong internal consistency (Cronbach's α=0.896), correlates highly with established psychedelic experience measures (MEQ-30, EDI, 5D-ASC), and could effectively guide dosing regimens for rapid-acting psychedelics.

Data attribution

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