A Phase 1 interventional study of N,N-Dimethyltryptamine in Healthy Volunteers, sponsored by Biomind Labs Inc.. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Biomind Labs Inc. · Phase 1, Interventional, and Treatment
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.
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.
Biomind Labs Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
Also known as: DMT, BMND01
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.
Time frame: up to 1 month after dosing
Blood Pressure
Assessed 20 times on each dose via systolic and diastolic blood pressure
Time frame: up to 2 hours after each dose
Heart rate
Assessed 20 times on each dose
Time frame: up to 2 hours after each dose
Respiratory rate
Assessed 20 times on each dose
Time frame: up to 2 hours after each dose
Oxygen saturation
Assessed 20 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of glucose
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of total cholesterol
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of C-reactive protein (CRP)
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of urea
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of creatinine
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of aspartate transaminase (AST)
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of alanine transaminase (ALT)
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
Plasma level of cortisol
Assessed 2 times on each dose
Time frame: up to 2 hours after each dose
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.
Time frame: up to 2 hours after each dose
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.
Time frame: up to 2 hours after each dose
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.
Time frame: up to 2 hours after each dose
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.
Time frame: up to 1 month after dosing
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.
Time frame: up to 1 month after dosing
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.
Time frame: up to 1 month after dosing
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.
Time frame: up to 1 month after dosing
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
Time frame: up to 1 month after dosing
Plan to share: No
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