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

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Advanced Integrative Medical Science Institute

Criteria

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.