Safety and Tolerability of DMT in Healthy Adults

Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Safety Issues
• Intervention / Treatment: Drug: N,N-Dimethyltryptamine; Drug: Placebo

Detailed Description

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • RN
    • Natal, RN, Brazil, 59012300
      • Hospital Universitário Onofre Lopes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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
• reported or clinically recognized thyroid disorders
• diagnosis or family suspicion of genetic monoamine deficiency oxidase
• previous adverse response to psychedelic substances
• symptoms or family members with a present or past psychotic disorder
• dissociative identity disorder
• bipolar affective disorder
• prodromal symptoms of schizophrenia
• problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
• acute or subacute risk of suicide
• acute flu symptoms
• symptoms of airway infection
• contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 60mg of N,N-Dimethyltryptamine; One inhaled dose of 60mg of vaporized DMT.	Drug: N,N-Dimethyltryptamine; DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.; Other Names: DMT
Placebo Comparator: Placebo-like; One inhaled dose of 1mg of vaporized DMT.	Drug: Placebo; DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma level of glucose	Assessed 2 times on each session	up to 2 hours
Plasma level of total cholesterol	Assessed 2 times on each session	up to 2 hours
Plasma level of C-reactive protein (CRP)	Assessed 2 times on each session	up to 2 hours
Plasma level of urea	Assessed 2 times on each session	up to 2 hours
Plasma level of creatinine	Assessed 2 times on each session	up to 2 hours
Plasma level of aspartate transaminase (AST)	Assessed 2 times on each session	up to 2 hours
Plasma level of alanine transaminase (ALT)	Assessed 2 times on each session	up to 2 hours
Plasma level of cortisol	Assessed 2 times on each session	up to 2 hours
Plasma level of subjective effects of DMT	Assessed 2 times on each session	up to 2 hours
Evaluate the subjective effects of DMT	Assessment of the acute subjective effects of DMT, compared to placebo, by 5D-ASC (5 Dimensions- Altered States of consciousness). Scores range from 0 to 94, where higher scores indicate more intense psychedelic subjective effects.	up to 2 hours
Evaluate the subjective effects of DMT	Assessment of the acute subjective effects of DMT, compared to placebo, by HRS (Hallucinogen Rating Scale). Scores range from 0 to 400, where higher scores indicate more intense psychedelic subjective effects.	up to 2 hours
Evaluate the subjective effects of DMT	Assessment of the acute subjective effects of DMT, compared to placebo, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects.	up to 2 hours
Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing	Assessment of the electrical cerebral activity in different bandwidth as alpha waves by EEG before, during and after each session.	up to 1 hours
Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing	Assessment of the electrical cerebral activity in different bandwidth as beta waves by EEG before, during and after each session.	up to 1 hours
Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing	Assessment of the electrical cerebral activity in different bandwidth as theta waves by EEG before, during and after each session.	up to 1 hours
Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers	Assessment of the subacute effects of DMT on EEG, including ERP (event-related potential ) generated from visual and auditory stimulation by applying a visual and auditory perception and imagination task.	up to 0.5 hours
Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers	Assessment of the acute effects of DMT in ERP (event-related potential) generated from auditory stimulation in an oddball protocol.	up to 0.5 hours
Evaluate the subacute effects of DMT on suggestibility	Assessment of the subacute effects of DMT on suggestibility by applying a suggestibility task named Creative Imagination Scale (CIS). Scores range from 0 to 40. Higher scores indicate more intense suggestibility.	up to 1 hours
Evaluate the influence of expectations	Assessment of the influence of expectations variables on subjective experience	up to 0.5 hours
Evaluate the influence of personality trait	Assessment of the influence of personality trait on suggestibility	up to 0.5 hours
Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography	Evaluate changes in serum DMT concentration over time measured in baseline, 2 and 50 minutes after each session.	up to 50 minutes

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: Draulio B. Araujo, Ph.D, Universidade Federal do Rio Grande do Norte

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: placebo; DMT; psychedelic; N,N-DMT; N,N-Dimethyltryptamine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Serotonin Antagonists; Hallucinogens; N,N-Dimethyltryptamine
• Other Study ID Numbers: DMTcog

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No