The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers.
The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.
Topic Healthy Subjects
Compound 5-MeO-DMT
Country Netherlands
Visit trial
Status
Completed
Results Published
No
Start date
13 March 2019
End date
04 October 2019
Chance of happening
100%
Phase
Phase I
Design
Open
Type
Interventional
Generation
Second
Participants
22
Sex
All
Age
18- 45
Therapy
No
Trial Details
The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.NCT Number NCT04640831
Sponsors & Collaborators
GH ResearchGH Research is developing several 5-MeO-DMT based therapeutic mechanisms for various mental health disorders.
Papers
A phase 1, dose-ranging study to assess safety and psychoactive effects of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in healthy volunteersThis Phase I study assessed the safety and psychoactive effects of 5-MeO-DMT (GH001) in healthy volunteers (n=22). Single doses of 6, 12, and 18 mg of the inhaled GH001 formulation of 5-MeO-DMT were able to induce a peak experience in a minority of participants. An individualized dose escalation regimen produced a peak experience in every participant. Measures of cognition, mood, and well-being were not affected by 5-MeO-DMT. Adverse events were generally mild and resolved spontaneously.