Clinical Study of DMT in Healthy Adults
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ClinicalTrials.gov Identifier: NCT05573568 |
Recruitment Status :
Completed
First Posted : October 10, 2022
Last Update Posted : February 15, 2023
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Condition or disease | Intervention/treatment | Phase |
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Healthy Volunteers | Drug: N,N-Dimethyltryptamine | Phase 1 |
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 |
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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).
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Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
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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).
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Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
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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).
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Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
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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).
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Drug: N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Names:
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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:
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- 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.
- Blood Pressure [ Time Frame: up to 2 hours after each dose ]Assessed 20 times on each dose via systolic and diastolic blood pressure
- Heart rate [ Time Frame: up to 2 hours after each dose ]Assessed 20 times on each dose
- Respiratory rate [ Time Frame: up to 2 hours after each dose ]Assessed 20 times on each dose
- Oxygen saturation [ Time Frame: up to 2 hours after each dose ]Assessed 20 times on each dose
- Plasma level of glucose [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of total cholesterol [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of C-reactive protein (CRP) [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of urea [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of creatinine [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of aspartate transaminase (AST) [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of alanine transaminase (ALT) [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- Plasma level of cortisol [ Time Frame: up to 2 hours after each dose ]Assessed 2 times on each dose
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
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 (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
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
Brazil | |
Hospital Universitário Onofre Lopes | |
Natal, Rio Grande Do Norte, Brazil, 59012300 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
N,N-DMT DMT N,N-Dimethyltryptamine Healthy Volunteers |
N,N-Dimethyltryptamine Hallucinogens Physiological Effects of Drugs Psychotropic Drugs Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Receptor Agonists |