Study of Harmine in Healthy Subjects

This Phase I dose-escalation trial (n=27) aimed to determine the maximum tolerated dose of harmine (part of the ayahuasca brew) in healthy volunteers.

Conducted by James Murrough from the Icahn School of Medicine at Mount Sinai, harmine was administered in an open-label dose-escalation design. Seven possible doses ranging from 100 mg to 1200 mg were tested. Each participant received a single oral dose of harmine, and adverse events were monitored closely.

The primary outcome measured was dose-limiting toxicity (DLT), which included adverse events assessed through various scales and physiological measurements. Secondary outcomes included assessing psychoactive effects using a Visual Analog Scale. The trial, completed in June 2023, provided valuable insights into the safety profile of harmine.

Topic Healthy Subjects
Compound Ayahuasca
Country United States of America
Visit trial
Status Completed
Results Published No
Start date 13 September 2022
End date 23 June 2023
Phase Phase I
Design Open
Type Interventional
Generation Second
Participants 25
Sex All
Age 18- 55
Therapy No

Trial Details

The present study is a phase I dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine.

NCT Number NCT05526430

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinai
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Data attribution

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