Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

This open-label, dose-ranging study (n=12) of a standardised Ayahuasca analog (SM-001) involves healthy adults aged 25-65. The Investigational New Drug SM-001, a decoction of Banisteriopsis caapi and Psychotria viridis, is administered in three dose levels (0.25, 0.5, or 1.5 ml/kg).

The study, led by Leanna J Standish, ND PhD, aims to assess safety and systemic exposure to SM-001. Plasma levels of biomarkers will be measured, and participants will be monitored for 28 days. The primary objective is to evaluate safety and tolerability, with secondary measures including short-term and longer-term psychological impacts, bioavailability of SM-001, and effects on blood levels of brain-derived nerve growth factor and cortisol. The study, registered with the National Library of Medicine, began on October 1, 2023, and is expected to conclude by June 30, 2024.

Topic Healthy Subjects
Compound Ayahuasca
Country United States of America
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