The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Tolerability of DMT in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05901012
Recruitment Status : Completed
First Posted : June 13, 2023
Last Update Posted : October 11, 2023
Sponsor:
Information provided by (Responsible Party):
Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.

Condition or disease Intervention/treatment Phase
Safety Issues Healthy Volunteers Drug: N,N-Dimethyltryptamine Drug: Placebo Phase 1

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model 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.
Masking: Double (Participant, Investigator)
Masking Description: 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
Primary Purpose: Treatment
Official Title: Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults
Actual Study Start Date : April 26, 2023
Actual Primary Completion Date : July 17, 2023
Actual Study Completion Date : July 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: up to 2 hours ]
    Assessed 7 times on each session

  2. Diastolic Blood Pressure [ Time Frame: up to 2 hours ]
    Assessed 7 times on each session

  3. Heart rate [ Time Frame: up to 2 hours ]
    Assessed 7 times on each session

  4. Respiratory rate [ Time Frame: up to 2 hours ]
    Assessed 7 times on each session

  5. Oxygen saturation [ Time Frame: up to 2 hours ]
    Assessed 7 times on each session


Secondary Outcome Measures :
  1. Plasma level of glucose [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  2. Plasma level of total cholesterol [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  3. Plasma level of C-reactive protein (CRP) [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  4. Plasma level of urea [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  5. Plasma level of creatinine [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  6. Plasma level of aspartate transaminase (AST) [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  7. Plasma level of alanine transaminase (ALT) [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  8. Plasma level of cortisol [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  9. Plasma level of subjective effects of DMT [ Time Frame: up to 2 hours ]
    Assessed 2 times on each session

  10. Evaluate the subjective effects of DMT [ Time Frame: up to 2 hours ]
    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.

  11. Evaluate the subjective effects of DMT [ Time Frame: up to 2 hours ]
    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.

  12. Evaluate the subjective effects of DMT [ Time Frame: up to 2 hours ]
    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.

  13. Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing [ Time Frame: up to 1 hours ]
    Assessment of the electrical cerebral activity in different bandwidth as alpha waves by EEG before, during and after each session.

  14. Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing [ Time Frame: up to 1 hours ]
    Assessment of the electrical cerebral activity in different bandwidth as beta waves by EEG before, during and after each session.

  15. Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing [ Time Frame: up to 1 hours ]
    Assessment of the electrical cerebral activity in different bandwidth as theta waves by EEG before, during and after each session.

  16. Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers [ Time Frame: up to 0.5 hours ]
    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.

  17. Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers [ Time Frame: up to 0.5 hours ]
    Assessment of the acute effects of DMT in ERP (event-related potential) generated from auditory stimulation in an oddball protocol.

  18. Evaluate the subacute effects of DMT on suggestibility [ Time Frame: up to 1 hours ]
    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.

  19. Evaluate the influence of expectations [ Time Frame: up to 0.5 hours ]
    Assessment of the influence of expectations variables on subjective experience

  20. Evaluate the influence of personality trait [ Time Frame: up to 0.5 hours ]
    Assessment of the influence of personality trait on suggestibility

  21. Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography [ Time Frame: up to 50 minutes ]
    Evaluate changes in serum DMT concentration over time measured in baseline, 2 and 50 minutes after each session.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05901012


Locations
Layout table for location information
Brazil
Hospital Universitário Onofre Lopes
Natal, RN, Brazil, 59012300
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
Layout table for investigator information
Principal Investigator: Draulio B. Araujo, Ph.D Universidade Federal do Rio Grande do Norte
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Draulio Barros de Araujo, PhD, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT05901012    
Other Study ID Numbers: DMTcog
First Posted: June 13, 2023    Key Record Dates
Last Update Posted: October 11, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Draulio Barros de Araujo, Universidade Federal do Rio Grande do Norte:
N,N-DMT
N,N-Dimethyltryptamine
DMT
placebo
psychedelic
Additional relevant MeSH terms:
Layout table for MeSH terms
N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
 Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists