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Clinical Study 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: NCT05573568
Recruitment Status : Completed
First Posted : October 10, 2022
Last Update Posted : February 15, 2023
Sponsor:
Collaborator:
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Biomind Labs Inc.

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults
Actual Study Start Date : June 1, 2022
Actual Primary Completion Date : November 1, 2022
Actual Study Completion Date : November 14, 2022

Arm Intervention/treatment
Experimental: Group A - single ascending dose
Administration 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).
Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
  • DMT
  • BMND01

Experimental: Group B - single ascending dose
Administration 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).
Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
  • DMT
  • BMND01

Experimental: Group C - single ascending dose
Administration 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).
Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
  • DMT
  • BMND01

Experimental: Group D - single ascending dose
Administration 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).
Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
  • DMT
  • BMND01

Experimental: Group E - single ascending dose
Administration 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).
Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
  • DMT
  • BMND01




Primary Outcome Measures :
  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 Outcome Measures :
  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



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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT05573568


Locations
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Brazil
Hospital Universitário Onofre Lopes
Natal, Rio Grande Do Norte, Brazil, 59012300
Sponsors and Collaborators
Biomind Labs Inc.
Universidade Federal do Rio Grande do Norte
Additional Information:
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Responsible Party: Biomind Labs Inc.
ClinicalTrials.gov Identifier: NCT05573568    
Other Study ID Numbers: BMND01
First Posted: October 10, 2022    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biomind Labs Inc.:
N,N-DMT
DMT
N,N-Dimethyltryptamine
Healthy Volunteers
Additional relevant MeSH terms:
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N,N-Dimethyltryptamine
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists