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CompletedPhase 1

Clinical Study of DMT in Healthy Adults

NCT05573568 · Biomind Labs Inc.

Closed to entry
Status
Not accepting participants
Phase 1
Phase
27
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation

    Measured over up to 1 month after dosing

  • Blood Pressure

    Measured over up to 2 hours after each dose

  • Heart rate

    Measured over up to 2 hours after each dose

  • Respiratory rate

    Measured over up to 2 hours after each dose

  • Oxygen saturation

    Measured over up to 2 hours after each dose

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * prior experience with N,N-Dimethyltryptamine (DMT) * present proof of vaccination against COVID-19 (Coronavírus) 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

Where

1 study site

FacilityCityRegionCountry
Hospital Universitário Onofre LopesNatalRio Grande do NorteBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05573568 on ClinicalTrials.gov →

Last updated in the registry 2023-02-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits