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Completed

NCT Number: NCT05573568

Clinical Study of DMT in Healthy Adults

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, 59012300, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • heart failure
  • liver failure
  • kidney failure
  • resistant hypertension
  • arrhythmia
  • valvular heart disease
  • 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

Treatment and study plan

N,N-Dimethyltryptamine

Drug

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

Other names: DMT, BMND01

Primary outcomes

  1. 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

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

  2. Blood Pressure

    Time frame: up to 2 hours after each dose

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

  3. Heart rate

    Time frame: up to 2 hours after each dose

    Assessed 20 times on each dose

  4. Respiratory rate

    Time frame: up to 2 hours after each dose

    Assessed 20 times on each dose

  5. Oxygen saturation

    Time frame: up to 2 hours after each dose

    Assessed 20 times on each dose

Secondary outcomes

  1. Plasma level of glucose

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  2. Plasma level of total cholesterol

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

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

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  4. Plasma level of urea

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  5. Plasma level of creatinine

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  6. Plasma level of aspartate transaminase (AST)

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  7. Plasma level of alanine transaminase (ALT)

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  8. Plasma level of cortisol

    Time frame: up to 2 hours after each dose

    Assessed 2 times on each dose

  9. Evaluate the subjective effects of DMT

    Time frame: up to 2 hours after each dose

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

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

    Time frame: up to 2 hours after each dose

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

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

    Time frame: up to 2 hours after each dose

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

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

    Time frame: up to 1 month after dosing

    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.

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

    Time frame: up to 1 month after dosing

    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.

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

    Time frame: up to 1 month after dosing

    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.

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

    Time frame: up to 1 month after dosing

    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.

  16. Evaluate the impact of DMT on affect using scale

    Time frame: up to 1 month after dosing

    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

Sponsors and collaborators

Lead sponsor

Biomind Labs Inc.

Industry

Collaborators

  • Universidade Federal do Rio Grande do Norte

Registry information

Official study title

Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2022
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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