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Safety IssuesPhase 1NCT05901012

Safety and Tolerability of DMT in Healthy Adults

A Phase 1 study testing N,N-Dimethyltryptamine in people with Safety Issues and Healthy Volunteers, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Safety Issues, Healthy Volunteers
What is being tested?
N,N-Dimethyltryptamine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteBrazil
Study dates
26 Apr 2023to 17 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • heart failure
  • liver failure
  • kidney failure
  • uncontrolled high blood pressure
  • history of heart rhythm disorders
  • history of valvular heart disease
Show all 27Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitário Onofre Lopes

    Natal, Rio Grande do Norte, 59012300

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
N,N-Dimethyltryptamine, Placebo
Keywords
N,N-DMT, N,N-Dimethyltryptamine, DMT, placebo, psychedelic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N,N-DimethyltryptamineDrug

    Also called DMT

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

  • PlaceboDrug

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

Study groups in NCT05901012
Study groupRoleWhat they receive
60mg of N,N-DimethyltryptamineExperimentalOne inhaled dose of 60mg of vaporized DMT.
Receives: Drug: N,N-Dimethyltryptamine
Placebo-likePlacebo comparatorOne inhaled dose of 1mg of vaporized DMT.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic Blood Pressure

    Assessed 7 times on each session

    Measured: up to 2 hours

  2. Diastolic Blood Pressure

    Assessed 7 times on each session

    Measured: up to 2 hours

  3. Heart rate

    Assessed 7 times on each session

    Measured: up to 2 hours

  4. Respiratory rate

    Assessed 7 times on each session

    Measured: up to 2 hours

  5. Oxygen saturation

    Assessed 7 times on each session

    Measured: up to 2 hours

Secondary outcomes (21)

  1. Plasma level of glucose

    Assessed 2 times on each session

    Measured: up to 2 hours

  2. Plasma level of total cholesterol

    Assessed 2 times on each session

    Measured: up to 2 hours

  3. Plasma level of C-reactive protein (CRP)

    Assessed 2 times on each session

    Measured: up to 2 hours

  4. Plasma level of urea

    Assessed 2 times on each session

    Measured: up to 2 hours

  5. Plasma level of creatinine

    Assessed 2 times on each session

    Measured: up to 2 hours

  6. Plasma level of aspartate transaminase (AST)

    Assessed 2 times on each session

    Measured: up to 2 hours

  7. Plasma level of alanine transaminase (ALT)

    Assessed 2 times on each session

    Measured: up to 2 hours

  8. Plasma level of cortisol

    Assessed 2 times on each session

    Measured: up to 2 hours

  9. Plasma level of subjective effects of DMT

    Assessed 2 times on each session

    Measured: up to 2 hours

  10. 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.

    Measured: up to 2 hours

  11. 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.

    Measured: up to 2 hours

  12. 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.

    Measured: up to 2 hours

  13. 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.

    Measured: up to 1 hours

  14. 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.

    Measured: up to 1 hours

  15. 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.

    Measured: up to 1 hours

  16. 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.

    Measured: up to 0.5 hours

  17. 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.

    Measured: up to 0.5 hours

  18. 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.

    Measured: up to 1 hours

  19. Evaluate the influence of expectations

    Assessment of the influence of expectations variables on subjective experience

    Measured: up to 0.5 hours

  20. Evaluate the influence of personality trait

    Assessment of the influence of personality trait on suggestibility

    Measured: up to 0.5 hours

  21. 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.

    Measured: up to 50 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start26 Apr 2023
  3. Primary completion17 Jul 2023
  4. Study completion17 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Participant, Investigator
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901012
Sponsor's protocol ID
DMTcog
Status last verified
Oct 2023
First submitted
22 May 2023
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40532423

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N,N-Dimethyltryptamine in people with Safety Issues and Healthy Volunteers, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: up to 2 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901012, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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