Clinical Study of DMT in Healthy Adults

Biomind Labs

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: N,N-Dimethyltryptamine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05573568

BMND01

Details and patient eligibility

About

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

Full description

Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 5 patient groups

Group A - single ascending dose

Experimental group

Description:

Administration of up to 2 inhaled doses of DMT within a single day (5 mg, followed by 20 mg) with a 2-hour dose interval (5 subjects).

Treatment:

Drug: N,N-Dimethyltryptamine

Group B - single ascending dose

Experimental group

Description:

Administration of up to 2 inhaled doses of DMT within a single day (7.5 mg, followed by 30 mg) with a 2-hour dose interval (5 subjects).

Treatment:

Drug: N,N-Dimethyltryptamine

Group C - single ascending dose

Experimental group

Description:

Administration of up to 2 inhaled doses of DMT within a single day (10 mg, followed by 40 mg) with a 2-hour dose interval (5 subjects).

Treatment:

Drug: N,N-Dimethyltryptamine

Group D - single ascending dose

Experimental group

Description:

Administration of up to 2 inhaled doses of DMT within a single day (12.5 mg, followed by 50 mg) with a 2-hour dose interval (5 subjects).

Treatment:

Drug: N,N-Dimethyltryptamine

Group E - single ascending dose

Experimental group

Description:

Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 2-hour dose interval (5 subjects).

Treatment:

Drug: N,N-Dimethyltryptamine