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.
Phase I, non-randomised sequential study in healthy volunteers evaluating single ascending doses (Part A) and an individualized dosing regimen (Part B) of inhaled GH001 (5‑MeO‑DMT).
Primary outcomes focus on safety and dose-related psychoactive effects; 22 participants enrolled across four ascending-dose groups and one individualized-dosing group.
Part A dose group A (single ascending dose).
GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group A.
Part A dose group B (single ascending dose).
GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group B.
Part A dose group C (single ascending dose).
GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group C.
Part A dose group D (single ascending dose).
GH001 (5‑MeO‑DMT) administered via inhalation — Part A single ascending dose group D.
Part B individualized dosing regimen.
GH001 (5‑MeO‑DMT; individualized dosing) administered via inhalation — Part B.
The three-item Peak Experience Scale (PES) reliably and rapidly measures the strength of 5‑MeO‑DMT experiences, showing dose-related increases, a single PCA component explaining 83.5% of variance, high internal consistency (α = 0.896) and strong correlations with established measures (MEQ-30, EDI, 5D-ASC) but not the CEQ. The authors conclude the PES could be used to gain fast insight into psychedelic intensity in individual patients and to guide dose and re-dose decisions for rapid-acting psychedelics.