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

July 5, 2023 updated by: Advanced Integrative Medical Science Institute
Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes.

This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98102
        • AIMS Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sunil K Aggarwal, MD, PhD
        • Principal Investigator:
          • Leanna J Standish, ND PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open label Phase I safety & dose finding study: low dose group
4 study participants will receive a low oral dose (0.5 mL/Kg) of SM-001
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).
Other Names:
  • Ayahuasca
Active Comparator: Open label Phase I safety & dose finding study: medium dose group
4 study participants will receive a medium oral dose (1.0 mL/Kg) of SM-001
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).
Other Names:
  • Ayahuasca
Active Comparator: Open label Phase I safety & dose finding study: high dose group
4 study participants will receive a high oral dose (2.0 mL/Kg) of SM-001
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).
Other Names:
  • Ayahuasca

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Objective
Time Frame: 1-28 days

To evaluate safety and tolerability of SM-001 in healthy adults following a single oral dose, at one of three different dose levels. The Incidence of Treatment-Emergent Adverse Events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE).

Percentage of participants with at least one safety event [Time Frame: Baseline up to Day 28 ] Safety will be evaluated by the monitoring of adverse events (AEs), vital signs, blood pressure, heart rate, pulse oximetry, electrocardiogram (ECG) evaluations, clinical laboratory assessments and physical examination findings.
1-28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term psychological impact
Time Frame: 24 hours after single drug session
To assess short-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Hallucinogenic Rating Scale 24 hours after the single experimental drug session. This is an 85 item questionnaire with each item rated 0-4 with a maximum score of 340. A higher score correlates with a more intense psychological experience.
24 hours after single drug session
Longer-term psychological impact
Time Frame: Day 7 after a single drug session

To assess longer-term psychological impact of a single dose of SM-001 at three different dose levels in healthy adults by asking each study subject to complete a questionnaire called the Persisting Effects Questionnaire 7 days following the single experimental drug session.

The Persisting Effects Questionnaire includes 140 of the items that are rated on a 6-point scale (0=none, not at all; 1=so slight cannot decide; 2=slight; 3=moderate; 4=strong; 5=extreme, more than ever before in your life and stronger than 4).
Day 7 after a single drug session
Bioavailability of SM-001
Time Frame: Day 1-2
To determine the blood, urine and feces levels of plant alkaloids including dimethyltryptamine, harmine, tetrahydroharmine and harmaline in ng/mL following a single oral dose of SM-001.
Day 1-2
Effects of a single dose of SM-001 on blood levels of brain derived nerve growth factor
Time Frame: Day 1-28
Brain Derived Neurotrophic Factor will be quantitated (ng/mL) is each study subject's blood on the day before and the day after the SM-001 drug session.
Day 1-28
Effects of a single dose of SM-001 on blood cortisol blood levels
Time Frame: Day 1 - 28
Cortisol levels in each study subject's blood will be measured (mg/mL)
Day 1 - 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Integrative Medical Science Institute

Investigators

  • Principal Investigator: Leanna J Standish, ND PhD, AIMS Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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