Clinical Study of DMT in Healthy Adults

Healthy Volunteers Clinical Trial

Official title:

Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05573568
• Other study ID #: BMND01
• Status: Completed
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: November 14, 2022

Study information

• Verified date: February 2023
• Source: Biomind Labs Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 14, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Locations

Country	Name	City	State
Brazil	Hospital Universitário Onofre Lopes	Natal	Rio Grande Do Norte

Sponsors (2)

Lead Sponsor	Collaborator
Biomind Labs Inc.	Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 month after dosing
Primary	Blood Pressure	Assessed 20 times on each dose via systolic and diastolic blood pressure	up to 2 hours after each dose
Primary	Heart rate	Assessed 20 times on each dose	up to 2 hours after each dose
Primary	Respiratory rate	Assessed 20 times on each dose	up to 2 hours after each dose
Primary	Oxygen saturation	Assessed 20 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of glucose	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of total cholesterol	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of C-reactive protein (CRP)	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of urea	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of creatinine	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of aspartate transaminase (AST)	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of alanine transaminase (ALT)	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	Plasma level of cortisol	Assessed 2 times on each dose	up to 2 hours after each dose
Secondary	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.	up to 2 hours after each dose
Secondary	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.	up to 2 hours after each dose
Secondary	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.	up to 2 hours after each dose
Secondary	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.	up to 1 month after dosing
Secondary	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.	up to 1 month after dosing
Secondary	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.	up to 1 month after dosing
Secondary	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.	up to 1 month after dosing
Secondary	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	up to 1 month after dosing

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