Clinical TrialHealthy VolunteersDMTDMTDMTDMTDMTCompleted

Clinical Study of DMT in Healthy Adults

Non-randomised, sequential Phase I inhaled DMT study (n=27) in healthy volunteers; two ascending inhaled doses given in fixed order on the same day, 2 hours apart.

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

Detailed Description

This Phase I sequential dose-escalation study evaluates the acute and subacute effects of inhaled N,N-dimethyltryptamine in healthy volunteers. Participants are enrolled in five cohorts, each receiving two inhaled doses in a fixed ascending order on the same day with a 2-hour interval.

Dosing is administered via a vaporizer device; cohort dose pairs range from 5→20 mg to 15→60 mg. Outcomes include safety and tolerability measures and assessment of acute and subacute subjective effects.

No structured psychological support is provided as part of the dosing sessions.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Group A

experimental

Up to 2 inhaled doses (5 mg then 20 mg) in fixed order, 2 h apart; cohort size 5.

Interventions

  • DMT20 mg
    via Inhalation• two sessions• 2 doses total

    Initial 5 mg then 20 mg, 2 h apart; cohort of 5.

Group B

experimental

Up to 2 inhaled doses (7.5 mg then 30 mg) in fixed order, 2 h apart; cohort size 5.

Interventions

  • DMT30 mg
    via Inhalation• two sessions• 2 doses total

    Initial 7.5 mg then 30 mg, 2 h apart; cohort of 5.

Group C

experimental

Up to 2 inhaled doses (10 mg then 40 mg) in fixed order, 2 h apart; cohort size 5.

Interventions

  • DMT40 mg
    via Inhalation• two sessions• 2 doses total

    Initial 10 mg then 40 mg, 2 h apart; cohort of 5.

Group D

experimental

Up to 2 inhaled doses (12.5 mg then 50 mg) in fixed order, 2 h apart; cohort size 5.

Interventions

  • DMT50 mg
    via Inhalation• two sessions• 2 doses total

    Initial 12.5 mg then 50 mg, 2 h apart; cohort of 5.

Group E

experimental

Up to 2 inhaled doses (15 mg then 60 mg) in fixed order, 2 h apart; cohort size 5.

Interventions

  • DMT60 mg
    via Inhalation• two sessions• 2 doses total

    Initial 15 mg then 60 mg, 2 h apart; cohort of 5.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • prior experience with N,N-Dimethyltryptamine (DMT)
  • present proof of vaccination against COVID-19 (Coronavírus)

Exclusion Criteria

  • Exclusion Criteria:
  • heart failure
  • liver failure
  • kidney failure
  • resistant hypertension
  • arrhythmia
  • valvular heart disease
  • chronic obstructive pulmonary disease
  • asthma
  • severe obesity
  • epilepsy
  • pregnancy
  • thyroid disorders
  • family diagnosis or suspicion of genetic monoamine oxidase deficiency
  • previous adverse response to psychedelic substances
  • present or past symptoms or family members with a psychotic disorder
  • dissociative identity disorder
  • bipolar disorder
  • prodromal symptoms of schizophrenia
  • abuse of alcohol or other psychoactive substances, except tobacco
  • acute or sub-acute risk of suicide
  • flu-like symptoms

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment27 participants
  • Timeline
    Start: 2022-06-01
    End: 2022-12-01
  • Compounds
    DMTDMTDMTDMTDMT
  • Topic
    Healthy Volunteers

Locations

Hospital Universitário Onofre Lopes — Natal, Rio Grande do Norte, Brazil

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