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Ayahuasca Analog
Oral SM-001 Safety and Dosing Study in Healthy Adults
Phase 1
Waitlist Available
Led By Leanna J Standish, ND PhD
Research Sponsored by Advanced Integrative Medical Science Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1-28
Awards & highlights
Study Summary
This trial tests if an Ayahuasca-like drug is safe and finds the right dose for healthy adults.
Who is the study for?
Healthy adults aged 25-65 with normal vital signs, blood counts, liver and kidney function can join. They must not use alcohol or recreational drugs for certain periods before the trial and cannot be pregnant or breastfeeding. Those with systemic conditions, drug/alcohol abuse history, psychiatric disorders, significant trauma history, BMI outside 20-30 range, seizure history or current psychoactive medication use are excluded.Check my eligibility
What is being tested?
The study is testing SM-001, a standardized Ayahuasca analog in healthy volunteers to find out the safest dose. It's an early-stage (Phase I) trial where participants will take the oral medication under supervision to assess its safety profile.See study design
What are the potential side effects?
Since this is a Phase I trial primarily focused on safety and dosage levels of SM-001 in humans, specific side effects are not listed but may include typical reactions associated with psychedelic substances such as sensory alterations and emotional changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1-28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1-28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Secondary outcome measures
Bioavailability of SM-001
Effects of a single dose of SM-001 on blood cortisol blood levels
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
+2 moreTrial Design
3Treatment groups
Active Control
Group I: Open label Phase I safety & dose finding study: low dose groupActive Control1 Intervention
4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001
Group II: Open label Phase I safety & dose finding study: medium dose groupActive Control1 Intervention
4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001
Group III: Open label Phase I safety & dose finding study: high dose groupActive Control1 Intervention
4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Advanced Integrative Medical Science InstituteLead Sponsor
2 Previous Clinical Trials
1,000 Total Patients Enrolled
Leanna J Standish, ND PhDPrincipal InvestigatorAIMS Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am being treated for or have a condition affecting my blood, immune system, liver, kidneys, heart, or nervous system.I am not taking SSRIs, MAO inhibitors, or other psychoactive drugs or supplements.My kidney function tests are normal.I am a healthy adult between 25 and 65 years old.I have a history of seizures.My blood pressure is normal without taking any medication.I am not pregnant or breastfeeding.I can avoid alcohol for 3 days before and after the start of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Open label Phase I safety & dose finding study: low dose group
- Group 2: Open label Phase I safety & dose finding study: medium dose group
- Group 3: Open label Phase I safety & dose finding study: high dose group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Which patient population is eligible to participate in this clinical trial?
"Eligibility requirements for this trial include having PTSD and falling within the age bracket of 25-65. At present, 12 participants are needed to complete the study."
Answered by AI
Has the Open label Phase I safety & dose finding study: low dose group received FDA certification?
"Since this study is in Phase 1, and there are minimal safety and effectiveness data available, Open label Phase I safety & dose finding study: low dose group garnered a score of 1."
Answered by AI
Are there currently openings for enrolled participants in this research?
"Clinicaltrials.gov indicates that this particular investigation is not presently recruiting patients; the study was originally posted on October 1st 2023 and last updated May 30th 2023. Fortunately, there are currently 701 other medical studies actively enrolling participants."
Answered by AI
Does this investigation permit individuals younger than 25 to be participants?
"This clinical trial states that it only accepts applicants between 25 and 65 years old. In comparison, there are 75 studies available for those under 18 while 530 exist for people above the age of 65."
Answered by AI
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