Clinical TrialHealthy VolunteersAyahuascaNot yet recruiting

An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers

Randomised crossover Phase I healthy volunteer study (n=8) assessing two oral DMT–harmala formulations with dose escalation (1.0→1.4 mg/kg DMT; 4→5.6 mg/kg harmala).

Target Enrollment
8 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Two orally administered DMT–harmala formulations will be tested in healthy volunteers in separate single-dose sessions with a two-week washout; an interim assessment determines formulation and dose escalation.

Safety and tolerability will be assessed via AEs/SAEs, vital signs (BP, ECG, pulse) and the Integration Difficulties Scale; mental health effects via DASS-21 acutely and at follow-ups.

Study Protocol

Preparation

sessions

Dosing

2 sessions
360 min each

Integration

sessions

Study Arms & Interventions

DMT + harmala

experimental

Two oral DMT–harmala formulations in a randomised crossover with interim safety review and dose escalation.

Interventions

  • Ayahuasca1 mg/kg
    via Oral• single dose

    Initial DMT 1.0 mg/kg + harmala 4 mg/kg; after interim assessment escalate to DMT 1.4 mg/kg + harmala 5.6 mg/kg.

Participants

Ages
25 – 70
Sexes
Male & Female

Inclusion Criteria

  • 1. 25 to 70-year-old men or women
  • 2. Medically and psychiatrically healthy as adjudicated by the investigator based on physical exam and MINI (DSM-5) psychiatric interview.
  • 3. Previous consumption of a DMT-harmaloid plant-based preparation
  • 4. Weigh between 50kg and 90kg + a BMI of 18 to 32.
  • 5. Voluntary consent to participate in the study (including follow-up visits) and to undergo the procedures requested.
  • 6. Confirmation that a friend or family member will assist them personally with transport after the active drug session that evening.
  • 7. Agree to alcohol abstinence 24 hours prior to the active treatment session and on the treatment day.
  • 8. Willing to follow advice regarding sexual activity during the study.

Exclusion Criteria

  • 1. History of psychosis: past or present diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • 2. Family history of psychosis: past or present diagnosis of bipolar disorder type 1 in first degree relative, or schizophrenia, or schizoaffective disorder in first or second degree relative.
  • 3. Current suicidality or history of suicide attempt.
  • 4. Current psychiatric disorder diagnosis.
  • 5. Daily/weekly high-risk alcohol use (as per NHMRC guidelines).
  • 6. Use of any psychoactive medication (e.g., a selective serotonin reuptake inhibitor such as paroxetine or citalopram), haloperidol, any medication with MAO activity (such as isocarboxazid, phenelzine, selegiline or tranylcypromine, linezolid, and methylene blue), or any drug that has been indicated as a potential precipitative agent for serotonin syndrome within 28 days prior to study drug administration and through to the end of study.
  • 7. Currently taking any other regular medication, including: Opiates, Anti-histamines, Anti-convulsants, Amphetamines, Kava, and St John’s wort.
  • 8. Used a hallucinogen in the past month (a one-month wash-out is acceptable)
  • 9. Smoking/using nicotine
  • 10. Substance/alcohol use disorder
  • 11. History of Hallucinogen Persisting Perception Disorder (HPPD).
  • 12. Serious medical condition e.g., Cardiovascular, Metabolic, Neurological, Respiratory, Oncological, haematological disorder.
  • 13. Serious ECG abnormality
  • 14. Serious abnormal haematology or electrolyte, renal or liver test result (indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.2X or total bilirubin 1.5 x upper limit of normal (ULN), which remains above these limits if retested) in the previous 12 months (as provided by their GP or SVHM).
  • 15. Not agreeing to fasting from midnight prior to the Dose Day sessions until the afternoon of that treatment day.
  • 16. Females who are pregnant, nursing, or trying to become pregnant (pregnancy test provided).
  • 17. Participation in another clinical study involving investigational study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment8 participants
  • Timeline
    Start: 2022-11-05
    End: 2023-04-21
  • Compound
    Ayahuasca
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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