Clinical TrialHealthy VolunteersDMTPlaceboCompleted

Safety and Tolerability of DMT in Healthy Adults

Phase I, double-blind, randomised, placebo-controlled crossover in healthy volunteers (n=25) comparing inhaled DMT 60 mg with a 1 mg placebo-like inhalation across two sessions on the same day.

Target Enrollment
25 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Detailed Description

Randomised, double-blind, placebo-controlled crossover assessing acute and subacute effects of inhaled N,N‑Dimethyltryptamine in healthy adults; each participant receives two inhalation sessions (DMT 60 mg and placebo-like 1 mg) the same day.

Primary focus is safety and tolerability with monitoring of vital signs, respiratory status, adverse events, and clinical assessments at acute and follow-up timepoints.

Study Protocol

Preparation

sessions

Dosing

2 sessions
120 min each

Integration

sessions

Study Arms & Interventions

DMT 60 mg

experimental

Single inhaled dose of vaporized DMT 60 mg.

Interventions

  • DMT60 mg
    via Inhalation• single dose• 1 doses total

    Vaporized DMT, single-session.

Placebo (1 mg)

inactive

Single inhaled dose of very low-dose DMT (placebo-like, 1 mg).

Interventions

  • Placebo1 mg
    via Inhalation• single dose• 1 doses total

    Placebo-like inhalation containing 1 mg DMT.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • previous experience with DMT
  • be right-handed
  • healthy volunteers

Exclusion Criteria

  • Exclusion Criteria:
  • heart failure
  • liver failure
  • kidney failure
  • uncontrolled high blood pressure
  • history of heart rhythm disorders
  • history of valvular heart disease
  • history of chronic obstructive pulmonary disease (COPD)
  • active or in treatment for bronchial asthma
  • severe obesity
  • coagulation disorders
  • clinical evidence or history of increased intracranial pressure
  • clinical evidence or history of cerebrospinal pressure
  • history or reports of epilepsy
  • severe neurological disease
  • pregnancy
  • reported or clinically recognized thyroid disorders
  • diagnosis or family suspicion of genetic monoamine deficiency oxidase
  • previous adverse response to psychedelic substances
  • symptoms or family members with a present or past psychotic disorder
  • dissociative identity disorder
  • bipolar affective disorder
  • prodromal symptoms of schizophrenia
  • problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
  • acute or subacute risk of suicide
  • acute flu symptoms
  • symptoms of airway infection
  • contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment25 participants
  • Timeline
    Start: 2023-04-26
    End: 2023-07-17
  • Compounds
    DMTPlacebo
  • Topic
    Healthy Volunteers

Locations

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

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