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

Status unconfirmed · Phase 1

Conditions studied: Major Depression, Post Traumatic Stress Disorder

In brief

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

Key facts

Study ID

NCT05894902

Run by

Advanced Integrative Medical Science Institute

People needed

12

Starts

2023-10-01

Expected to finish

2024-06-30

Last updated by the study team

2023-07-07

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 it is running

• AIMS Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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