Clinical Study of DMT in Healthy Adults

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: N,N-Dimethyltryptamine

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59012300
      • Hospital Universitário Onofre Lopes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: N,N-Dimethyltryptamine; DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen; Other Names: DMT; BMND01
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).	Drug: N,N-Dimethyltryptamine; DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen; Other Names: DMT; BMND01
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).	Drug: N,N-Dimethyltryptamine; DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen; Other Names: DMT; BMND01
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).	Drug: N,N-Dimethyltryptamine; DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen; Other Names: DMT; BMND01
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: DMT; BMND01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood Pressure	Assessed 20 times on each dose via systolic and diastolic blood pressure	up to 2 hours after each dose
Heart rate	Assessed 20 times on each dose	up to 2 hours after each dose
Respiratory rate	Assessed 20 times on each dose	up to 2 hours after each dose
Oxygen saturation	Assessed 20 times on each dose	up to 2 hours after each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma level of glucose	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of total cholesterol	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of C-reactive protein (CRP)	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of urea	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of creatinine	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of aspartate transaminase (AST)	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of alanine transaminase (ALT)	Assessed 2 times on each dose	up to 2 hours after each dose
Plasma level of cortisol	Assessed 2 times on each dose	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.	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.	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.	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.	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.	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.	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	up to 1 month after dosing
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

Collaborators and Investigators

• Sponsor: Biomind Labs Inc.
• Collaborators: Universidade Federal do Rio Grande do Norte

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Volunteers; DMT; N,N-DMT; N,N-Dimethyltryptamine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Agents; Serotonin Receptor Agonists; Serotonin Antagonists; Hallucinogens; N,N-Dimethyltryptamine
• Other Study ID Numbers: BMND01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No