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Healthy VolunteersPhase 1NCT05573568

Clinical Study of DMT in Healthy Adults

A Phase 1 study testing N,N-Dimethyltryptamine in people with Healthy Volunteers, run by Biomind Labs Inc. 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 in healthy individuals. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
N,N-Dimethyltryptamine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteBrazil
Study dates
1 Jun 2022to 14 Nov 2022
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • prior experience with N,N-Dimethyltryptamine (DMT)
  • present proof of vaccination against COVID-19 (Coronavírus)

Who cannot join

  • heart failure
  • liver failure
  • kidney failure
  • resistant hypertension
  • arrhythmia
  • valvular heart disease
Show all 21Show fewer
  • chronic obstructive pulmonary disease
  • asthma
  • severe obesity
  • epilepsy
  • pregnancy
  • thyroid disorders
  • family diagnosis or suspicion of genetic monoamine oxidase deficiency
  • previous adverse response to psychedelic substances
  • present or past symptoms or family members with a psychotic disorder
  • dissociative identity disorder
  • bipolar disorder
  • prodromal symptoms of schizophrenia
  • abuse of alcohol or other psychoactive substances, except tobacco
  • acute or sub-acute risk of suicide
  • flu-like symptoms

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 Phase I Study in Healthy Adults

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

Read the detailed description

Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.

Being tested
N,N-Dimethyltryptamine
Keywords
N,N-DMT, DMT, N,N-Dimethyltryptamine, Healthy Volunteers

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, BMND01

    DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Study groups in NCT05573568
Study groupRoleWhat they receive
Group A - single ascending doseExperimentalAdministration of up to 2 inhaled doses of DMT within a single day (5 mg, followed by 20 mg) with a 2-hour dose interval (5 subjects).
Receives: Drug: N,N-Dimethyltryptamine
Group B - single ascending doseExperimentalAdministration of up to 2 inhaled doses of DMT within a single day (7.5 mg, followed by 30 mg) with a 2-hour dose interval (5 subjects).
Receives: Drug: N,N-Dimethyltryptamine
Group C - single ascending doseExperimentalAdministration of up to 2 inhaled doses of DMT within a single day (10 mg, followed by 40 mg) with a 2-hour dose interval (5 subjects).
Receives: Drug: N,N-Dimethyltryptamine
Group D - single ascending doseExperimentalAdministration of up to 2 inhaled doses of DMT within a single day (12.5 mg, followed by 50 mg) with a 2-hour dose interval (5 subjects).
Receives: Drug: N,N-Dimethyltryptamine
Group E - single ascending doseExperimentalAdministration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 2-hour dose interval (5 subjects).
Receives: Drug: N,N-Dimethyltryptamine

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation

    Evaluate clinical and psychiatry acute risks after DMT treatments assessed by qualitative medical evaluation after dosing.

    Measured: up to 1 month after dosing

  2. Blood Pressure

    Assessed 20 times on each dose via systolic and diastolic blood pressure

    Measured: up to 2 hours after each dose

  3. Heart rate

    Assessed 20 times on each dose

    Measured: up to 2 hours after each dose

  4. Respiratory rate

    Assessed 20 times on each dose

    Measured: up to 2 hours after each dose

  5. Oxygen saturation

    Assessed 20 times on each dose

    Measured: up to 2 hours after each dose

Secondary outcomes (16)

  1. Plasma level of glucose

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  2. Plasma level of total cholesterol

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

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

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  4. Plasma level of urea

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  5. Plasma level of creatinine

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  6. Plasma level of aspartate transaminase (AST)

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  7. Plasma level of alanine transaminase (ALT)

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  8. Plasma level of cortisol

    Assessed 2 times on each dose

    Measured: up to 2 hours after each dose

  9. Evaluate the subjective effects of DMT

    Assessment of the acute subjective effects of DMT by Hallucinogen Rating Scale (HRS) after each dosing. Higher scores indicate more intense psychedelic subjective effects.

    Measured: up to 2 hours after each dose

  10. Evaluate acute effects on cerebral activity using electroencephalography before, during and after the dosing

    Assessment of the electrical cerebral activity in different bandwidth as alpha, beta, theta waves by EEG before, during and after each dosing.

    Measured: up to 2 hours after each dose

  11. Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography

    Evaluate changes in serum DMT concentration over time measured in 2, 5, 10, 15 and 120 minutes after each dosing.

    Measured: up to 2 hours after each dose

  12. Evaluate the impact of after DMT on satisfaction with life using scale

    Assessment of satisfaction with life in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the Satisfaction with Life Scale (SWL). Scores ranging from 5 to 35. Higher scores indicate greater satisfaction with life.

    Measured: up to 1 month after dosing

  13. Evaluate the impact of DMT on trait and state of anxiety using scale

    Assessment of trait and state anxiety in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the State-Trait Anxiety Inventory (STAI). Scores ranging from 0 to 63. Higher scores indicate more severe anxiety.

    Measured: up to 1 month after dosing

  14. Evaluate the impact of DMT on quality of life using scale

    Assessment of quality of life in different time points as baseline, 14 and 28 days after dosing using the questionnaires World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF). Scores ranging from 0 to 100.

    Higher scores indicate better quality of life.

    Measured: up to 1 month after dosing

  15. Evaluate the impact of DMT on spirituality, religiousness and personal beliefs

    Assessment of spirituality, religiousness and personal beliefs in different time points as baseline, 14 and 28 days after dosing using the World Health Organization Quality of Life Assessment Instrument for Spirituality, Religiousness and Personal Beliefs (WHOQOL-SRPB). The scale is divided in 8 domains, scores ranging from 4 to 20 in each domain.

    Higher levels indicate higher level of spirituality, religiousness and personal beliefs.

    Measured: up to 1 month after dosing

  16. Evaluate the impact of DMT on affect using scale

    Assessment of affect in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the questionnaire Positive and Negative Affect Schedule (PANAS). To score the positive affect items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of positive affect. To score the negative affect items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of negative affect

    Measured: up to 1 month after dosing

Timeline

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

  1. First posted10 Oct 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Nov 2022
  4. Study completion14 Nov 2022

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573568
Sponsor's protocol ID
BMND01
Status last verified
Feb 2023
First submitted
6 Oct 2022
Last updated
15 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Swieczkowski D, Kwasny A, Cubala WJ. Safety and tolerability of NN-dimethyltryptamine (DMT) in healthy volunteers and Major Depressive Disorder (MDD) patients: A systematic review of early-phase clinical trials. Prog Neuropsychopharmacol Biol Psychiatry. 2025 Jul 13;140:111419. doi: 10.1016/j.pnpbp.2025.111419. Epub 2025 Jun 7.

    PubMed 40484114

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing N,N-Dimethyltryptamine in people with Healthy Volunteers, run by Biomind Labs Inc. 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 2 inclusion and 21 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 15 Feb 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. 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?

Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation (time frame: up to 1 month after dosing). 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 NCT05573568, 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 15 Feb 2023.

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