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Clinical Study of DMT in Healthy Adults

Sponsor
Biomind Labs Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05573568
Collaborator
Universidade Federal do Rio Grande do Norte (Other)
30
Enrollment
1
Location
2
Arms
5.5
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 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 :
Jun 1, 2022
Actual Primary Completion Date :
Nov 1, 2022
Actual Study Completion Date :
Nov 14, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Low dose

Subjects will receive 0.1 mg/kg of N, N-Dimethyltryptamine administered via inhalation

Drug: N,N-Dimethyltryptamine
A single dose of N, N-Dimethyltryptamine will be administered using a vaporizer device
Other Names:
  • DMT
  • BMND01

    		•
    Experimental: High dose

    Subjects will receive 0.7 mg/kg of N, N-Dimethyltryptamine administered via inhalation

    Drug: N,N-Dimethyltryptamine
    A single dose of N, N-Dimethyltryptamine will be administered using a vaporizer device
    Other Names:
  • DMT
  • BMND01

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation [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 [up to 2 hours after each dose]

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

    3. Heart rate [up to 2 hours after each dose]

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

    4. Respiratory rate [up to 2 hours after each dose]

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

    5. Oxygen saturation [up to 2 hours after each dose]

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

    Secondary Outcome Measures

    1. Plasma level of Brain-Derived Neurotrophic Factor (BDNF) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    2. Plasma level of Interleukin 6 (IL-6) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    3. Plasma level of Interleukin 10 (IL-10) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    4. Plasma level of tumor necrosis factor alpha (TNF-a) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    5. Plasma level of glucose [up to 2 hours after each dose]

      Assessed 2 times on each dose

    6. Plasma level of total cholesterol [up to 2 hours after each dose]

      Assessed 2 times on each dose

    7. Plasma level of C-reactive protein (CRP) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    8. Plasma level of urea [up to 2 hours after each dose]

      Assessed 2 times on each dose

    9. Plasma level of creatinine [up to 2 hours after each dose]

      Assessed 2 times on each dose

    10. Plasma level of aspartate transaminase (AST) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    11. Plasma level of alanine transaminase (ALT) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    12. Plasma level of cortisol [up to 2 hours after each dose]

      Assessed 2 times on each dose

    13. Plasma level of Growth hormone (GH) [up to 2 hours after each dose]

      Assessed 2 times on each dose

    14. Evaluate the subjective effects of DM [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.

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

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

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

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

    19. Evaluate the impact of DMT on quality of life using scale [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.

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

    21. Evaluate the impact of DMT on affect using scale [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • prior experience with N,N-Dimethyltryptamine (DMT)

    • present proof of vaccination against COVID-19

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitário Onofre Lopes Natal Rio Grande Do Norte Brazil 59012300

    Sponsors and Collaborators

    • Biomind Labs Inc.
    • Universidade Federal do Rio Grande do Norte

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Biomind Labs Inc.
    ClinicalTrials.gov Identifier:
    NCT05573568
    Other Study ID Numbers:
    • BMND01
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Nov 22, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    N,N-Dimethyltryptamine

    Study Results

    No Results Posted as of Nov 22, 2022