Clinical Study of DMT in Healthy Adults

NCT ID: NCT05573568

Last Updated: 2023-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2022-11-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A - single ascending dose

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).

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Group B - single ascending dose

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).

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Group C - single ascending dose

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).

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Group D - single ascending dose

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).

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Group E - single ascending dose

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).

Group Type EXPERIMENTAL

N,N-Dimethyltryptamine

Intervention Type DRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Interventions

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N,N-Dimethyltryptamine

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Intervention Type DRUG

Other Intervention Names

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DMT BMND01

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role collaborator

Biomind Labs Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, Brazil

Site Status

Countries

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Brazil

Related Links

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Other Identifiers

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BMND01

Identifier Type: -

Identifier Source: org_study_id

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