Safety and Tolerability of DMT in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901012
• Other study ID #: DMTcog
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: July 17, 2023

Study information

• Verified date: October 2023
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Safety Issues

Intervention

Drug:
• N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.
• Placebo
DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Onofre Lopes	Natal	RN

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Blood Pressure	Assessed 7 times on each session	up to 2 hours
Primary	Diastolic Blood Pressure	Assessed 7 times on each session	up to 2 hours
Primary	Heart rate	Assessed 7 times on each session	up to 2 hours
Primary	Respiratory rate	Assessed 7 times on each session	up to 2 hours
Primary	Oxygen saturation	Assessed 7 times on each session	up to 2 hours
Secondary	Plasma level of glucose	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of total cholesterol	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of C-reactive protein (CRP)	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of urea	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of creatinine	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of aspartate transaminase (AST)	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of alanine transaminase (ALT)	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of cortisol	Assessed 2 times on each session	up to 2 hours
Secondary	Plasma level of subjective effects of DMT	Assessed 2 times on each session	up to 2 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the influence of expectations	Assessment of the influence of expectations variables on subjective experience	up to 0.5 hours
Secondary	Evaluate the influence of personality trait	Assessment of the influence of personality trait on suggestibility	up to 0.5 hours
Secondary	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

External Links

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