Clinical trial NCT05901012: Safety and Tolerability of DMT in Healthy Adults
Official title: Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Issues
Healthy Volunteers
Keywords: N,N-DMT
N,N-Dimethyltryptamine
DMT
placebo
psychedelic
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours, the substance order will be randomized.
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.

Detailed description: This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours; the substance order will be randomized.

Eligibility criteria: Inclusion Criteria:

* previous experience with DMT
* be right-handed
* healthy volunteers

Exclusion Criteria:

* heart failure
* liver failure
* kidney failure
* uncontrolled high blood pressure
* history of heart rhythm disorders
* history of valvular heart disease
* history of chronic obstructive pulmonary disease (COPD)
* active or in treatment for bronchial asthma
* severe obesity
* coagulation disorders
* clinical evidence or history of increased intracranial
* clinical evidence or history of cerebrospinal pressure
* history or reports of epilepsy
* severe neurological disease,
* pregnancy
* reported or clinically recognized thyroid disorders
* diagnosis or family suspicion of genetic monoamine deficiency oxidase
* previous adverse response to psychedelic substances
* symptoms or family members with a present or past psychotic disorder
* dissociative identity disorder
* bipolar affective disorder
* prodromal symptoms of schizophrenia
* problematic use or abuse of alcohol or other psychoactive substances (except tobacco)
* acute or subacute risk of suicide
* acute flu symptoms
* symptoms of airway infection
* contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: up to 2 hours
measure: Diastolic Blood Pressure
timeFrame: up to 2 hours
measure: Heart rate
timeFrame: up to 2 hours
measure: Respiratory rate
timeFrame: up to 2 hours
measure: Oxygen saturation
timeFrame: up to 2 hours
Secondary outcomes:
measure: Plasma level of glucose
timeFrame: up to 2 hours
measure: Plasma level of total cholesterol
timeFrame: up to 2 hours
measure: Plasma level of C-reactive protein (CRP)
timeFrame: up to 2 hours
measure: Plasma level of urea
timeFrame: up to 2 hours
measure: Plasma level of creatinine
timeFrame: up to 2 hours
measure: Plasma level of aspartate transaminase (AST)
timeFrame: up to 2 hours
measure: Plasma level of alanine transaminase (ALT)
timeFrame: up to 2 hours
measure: Plasma level of cortisol
timeFrame: up to 2 hours
measure: Plasma level of subjective effects of DMT
timeFrame: up to 2 hours
measure: Evaluate the subjective effects of DMT
timeFrame: up to 2 hours
measure: Evaluate the subjective effects of DMT
timeFrame: up to 2 hours
measure: Evaluate the subjective effects of DMT
timeFrame: up to 2 hours
measure: Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing
timeFrame: up to 1 hours
measure: Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing
timeFrame: up to 1 hours
measure: Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing
timeFrame: up to 1 hours
measure: Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers
timeFrame: up to 0.5 hours
measure: Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers
timeFrame: up to 0.5 hours
measure: Evaluate the subacute effects of DMT on suggestibility
timeFrame: up to 1 hours
measure: Evaluate the influence of expectations
timeFrame: up to 0.5 hours
measure: Evaluate the influence of personality trait
timeFrame: up to 0.5 hours
measure: Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography
timeFrame: up to 50 minutes
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Hospital Universitário Onofre Lopes
state: RN
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Draulio B. Araujo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: