Clinical Study of DMT in Healthy Adults
- Registration Number
- NCT05573568
- Lead Sponsor
- Biomind Labs Inc.
- Brief Summary
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- prior experience with N,N-Dimethyltryptamine (DMT)
- present proof of vaccination against COVID-19 (Coronavírus)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group A - single ascending dose N,N-Dimethyltryptamine 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). Group B - single ascending dose 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). Group E - single ascending dose 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). Group D - single ascending dose 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). Group C - single ascending dose 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).
- Primary Outcome Measures
Name Time Method 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.
Heart rate up to 2 hours after each dose Assessed 20 times on each dose
Respiratory rate up to 2 hours after each dose Assessed 20 times on each dose
Oxygen saturation up to 2 hours after each dose Assessed 20 times on each dose
Blood Pressure up to 2 hours after each dose Assessed 20 times on each dose via systolic and diastolic blood pressure
- Secondary Outcome Measures
Name Time Method 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.
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.Plasma level of aspartate transaminase (AST) up to 2 hours after each dose Assessed 2 times on each dose
Plasma level of alanine transaminase (ALT) up to 2 hours after each dose Assessed 2 times on each dose
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.
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
Plasma level of C-reactive protein (CRP) up to 2 hours after each dose Assessed 2 times on each dose
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.
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.Plasma level of glucose up to 2 hours after each dose Assessed 2 times on each dose
Plasma level of urea up to 2 hours after each dose Assessed 2 times on each dose
Plasma level of total cholesterol up to 2 hours after each dose Assessed 2 times on each dose
Plasma level of creatinine up to 2 hours after each dose Assessed 2 times on each dose
Evaluate the subjective effects of DMT 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.
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.
Plasma level of cortisol up to 2 hours after each dose Assessed 2 times on each dose
Trial Locations
- Locations (1)
Hospital Universitário Onofre Lopes
🇧🇷Natal, Rio Grande Do Norte, Brazil