Safety and Tolerability of DMT in Healthy Adults

NCT05901012 | Completed Phase 1 DMC

• 1 other identifier: DMTcog
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Safety Issues; Healthy Volunteers

Keywords

N,N-DMT; N,N-Dimethyltryptamine; DMT; placebo; psychedelic

Outcome Measures

Primary Outcomes (5)

• Systolic Blood Pressure

  Assessed 7 times on each session

  up to 2 hours

• Diastolic Blood Pressure

  Assessed 7 times on each session

  up to 2 hours

• Heart rate

  Assessed 7 times on each session

  up to 2 hours

• Respiratory rate

  Assessed 7 times on each session

  up to 2 hours

• Oxygen saturation

  Assessed 7 times on each session

  up to 2 hours

Secondary Outcomes (21)

• Plasma level of glucose

  up to 2 hours

• Plasma level of total cholesterol

  up to 2 hours

• Plasma level of C-reactive protein (CRP)

  up to 2 hours

• Plasma level of urea

  up to 2 hours

• Plasma level of creatinine

  up to 2 hours

Study Arms (2)

60mg of N,N-Dimethyltryptamine

EXPERIMENTAL

One inhaled dose of 60mg of vaporized DMT.

Drug: N,N-Dimethyltryptamine

Placebo-like

PLACEBO COMPARATOR

One inhaled dose of 1mg of vaporized DMT.

Drug: Placebo

Interventions

N,N-Dimethyltryptamine DRUG

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Also known as: DMT

60mg of N,N-Dimethyltryptamine

Placebo DRUG

DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Placebo-like

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• previous experience with DMT
• be right-handed
• healthy volunteers

You may not qualify if:

• 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
• clinical evidence or history of cerebrospinal pressure
• history or reports of epilepsy
• severe neurological disease,
• pregnancy

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, 59012300, Brazil

Location

Related Publications (1)

• Wiessner I, Falchi-Carvalho M, Laborde S, Barros H, Bolcont R, Ruschi Silva S, Pantrigo E, Medina M, Arichelle F, Almeida R, Aires R, Nunes Ferreira LF, Dantas Correa L, Da Costa Bezerra RB, Thie K, Silva-Costa N, de Araujo Costa Neto LA, Jales Lima de Queiroz MV, Galvao-Coelho N, Araujo D, Palhano-Fontes F. Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial. Eur Neuropsychopharmacol. 2025 Aug;97:16-27. doi: 10.1016/j.euroneuro.2025.06.002. Epub 2025 Jun 17.

  PMID: 40532423 DERIVED

Related Links

• Hospital Universitário Onofre Lopes - UFRN (Federal University of Rio Grande do Norte)

MeSH Terms

Interventions

N,N-Dimethyltryptamine

Intervention Hierarchy (Ancestors)

Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Draulio B. Araujo, Ph.D

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study employs a double-blind design. The participant and investigator will all be blind to the order of substance administration during the dosing sessions. Each participant will undergo two dosing sessions on the same day, one with N,N-Dimethyltryptamine (DMT) at a dosage of 60 mg, and another with a placebo containing 1 mg of DMT. The order of substance administration (DMT or placebo) will be randomized and unknown to all parties involved in the study until data collection is complete to ensure unbiased results
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours, the substance order will be randomized.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 13, 2023
• Study Start: April 26, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)