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Unknown statusPhase 1

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

NCT05894902 · Advanced Integrative Medical Science Institute

Closed to entry
Status
Not accepting participants
Phase 1
Phase
12
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Primary Objective

    Measured over 1-28 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Healthy adults: men and women ages 25-65 years of age * Previous experience with a psychedelic drug * Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate * Normal blood pressure (for age) in the absence of antihypertensive drugs * Normal complete blood count and differential, platelets, coagulation ((PT/PTT) * Liver function tests ≤ 1.5X upper limits of normal * Renal function (BUN, serum Creatinine) - within normal limits * Able to understand and willing to comply with Study Protocol requirements. * Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0 * No use of recreational drugs for at least 14 days prior to Study Day 0. * Women who are not pregnant or lactating. Exclusion Criteria (None can apply): * Body Mass Index \> 30 or \< 20 * Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters. * History of seizures * History of drug or alcohol abuse * History of psychiatric disorder or history of significant trauma, as defined by DSM- V. * Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort) * Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.

Where

1 study site

FacilityCityRegionCountry
AIMS InstituteSeattleWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05894902 on ClinicalTrials.gov →

Last updated in the registry 2023-07-07. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits