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

NCT05894902 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-07-07

No results posted yet for this study

Summary

Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers

Conditions

Interventions

DRUG

SM-001

The Investigational New Drug SM-001 is formulated as a hot water decoction of two proprietary clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV).

Sponsors & Collaborators

  • Advanced Integrative Medical Science Institute

    lead OTHER

Principal Investigators

  • Leanna J Standish, ND PhD · AIMS Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-04-30
Completion
2024-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894902 on ClinicalTrials.gov