CompletedPhase 1

Clinical Study of DMT in Healthy Adults

Brazil27 participantsStarted 2022-06-01

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: up to 1 month after dosing

Blood Pressure

Timeframe: up to 2 hours after each dose

Heart rate

Timeframe: up to 2 hours after each dose

Respiratory rate

Timeframe: up to 2 hours after each dose

Oxygen saturation

Timeframe: up to 2 hours after each dose

Trial details

NCT IDNCT05573568

SponsorBiomind Labs Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-01

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