A Phase 1 single ascending dose study of pure oral harmine in healthy volunteers.

ABSTRACT:

Background

Harmine is a component of the hallucinogenic brew, Ayahuasca, which also contains the psychoactive compound, N, N-dimethyltryptamine. Whether pharmaceutical-grade harmine hydrochloride (HCl) has psychoactive effects, the doses at which these might occur, and the dose-response relationship to side effects and safety in humans are unknown.

Methods

We conducted a Phase 1, open-label single ascending dose trial in healthy adults with normal body mass index and no prior psychiatric illness. The primary goal was to determine the maximum tolerated dose (MTD) of oral pharmaceutical-grade harmine HCl and to characterize safety and tolerability. A secondary goal was to ascertain whether any oral dose has psychoactive effects.

Results

Thirty-four adult p

SUBMITTER: Ables JL 

PROVIDER: S-EPMC11549898 | biostudies-literature | 2024 Oct

REPOSITORIES: biostudies-literature