Clinical TrialHealthy VolunteersAyahuascaCompleted

Study of Harmine in Healthy Subjects

Phase I open-label, single-ascending-dose study (n=27) using CRM to determine the maximum tolerated oral dose of harmine in healthy volunteers.

Target Enrollment
27 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label phase I dose-escalation study in healthy adults using the continual reassessment method to identify the maximum tolerated dose of harmine; single oral dose per subject.

Seven potential dose levels (100–1200 mg) are evaluated with continuous medical monitoring on the treatment day; adverse events and dose-limiting toxicities inform subsequent dosing decisions.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Harmine Dose

experimental

Single-ascending oral dose harmine (seven possible doses) using continual reassessment method to determine MTD.

Interventions

  • Ayahuasca100 - 1200 mg
    via Oral• single dose• 1 doses total

    Dose-escalation CRM with possible doses: 100, 200, 300, 500, 700, 900, 1200 mg; single oral capsule.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria
  • Male or female aged 18-55 years;
  • Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process;
  • Body Mass Index (BMI) between 19 and 30;
  • Women of childbearing potential and men must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator;
  • Women must not be breastfeeding;

Exclusion Criteria

  • Exclusion Criteria
  • Children under the age of 18 and adults over the age of 55 due to concerns regarding neurodevelopmental and neurocognitive effects, respectively.
  • Individuals who are underweight as defined as a BMI <19, or who are obese as defined as >30 according to the Centers for Disease Control (CDC). These criteria are in line with the goals of a phase I dose finding and pharmacokinetic study.
  • Presence of a significant medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry;
  • Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases;
  • Presence of neurocognitive or dementing disorders;
  • Presence or history of psychiatric disorder as diagnosed by Mini Neuropsychiatric Interview (MINI);
  • Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol;
  • Medications with primary central nervous system (CNS) effects are dis-allowed, including psychotropic medications, antidepressants, benzodiazepines, centrally acting hypnotic agents, and centrally acting anti-migraine therapies;
  • Medications with primary cardiovascular effects are dis-allowed, including beta-adrenergic antagonists, ACE inhibitors, calcium channel blockers, and diuretics;
  • Any OTC medications or herbal remedies (see concomitant medications listed above) that could interfere with the study drug, pose a risk to the subject, or contain high tyramine as outlined in the Low Tyramine Diet attachment and above in the concomitant medication summary;
  • Any other medications that, in the opinion of the investigators, would pose a safety risk to the patient or that would interfere with the interpretation of study results; Positive pregnancy test at screen or on the morning of the treatment day in women of childbearing potential;
  • Systolic blood pressure outside the range of 100 - 140 mmHg, diastolic blood pressure outside the range of 60 - 90 mmHg, and pulse rate at rest > 100 or < 60 bpm;
  • History of positive tests for hepatitis B surface antigen, hepatitis C antibodies;
  • History of HIV;
  • Significant ECG abnormalities as follows:
  • Heart Rate < 60 and >100 bpm
  • PR Interval <120 and > 220 ms
  • QRS duration < 70 and >120 ms
  • QTC Interval (Bazett) > 450 ms

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment27 participants
  • Timeline
    Start: 2022-09-13
    End: 2023-06-23
  • Compound
    Ayahuasca
  • Topic
    Healthy Volunteers

Locations

Depression and Anxiety Center — New York, New York, United States

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