Safety and Tolerability of DMT in Healthy Adults
- Conditions
- Healthy VolunteersSafety Issues
- Interventions
- Drug: Placebo
- Registration Number
- NCT05901012
- Lead Sponsor
- Universidade Federal do Rio Grande do Norte
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- previous experience with DMT
- be right-handed
- healthy volunteers
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo-like Placebo One inhaled dose of 1mg of vaporized DMT. 60mg of N,N-Dimethyltryptamine N,N-Dimethyltryptamine One inhaled dose of 60mg of vaporized DMT.
- Primary Outcome Measures
Name Time Method Systolic Blood Pressure up to 2 hours Assessed 7 times on each session
Heart rate up to 2 hours Assessed 7 times on each session
Respiratory rate up to 2 hours Assessed 7 times on each session
Diastolic Blood Pressure up to 2 hours Assessed 7 times on each session
Oxygen saturation up to 2 hours Assessed 7 times on each session
- Secondary Outcome Measures
Name Time Method Plasma level of total cholesterol up to 2 hours Assessed 2 times on each session
Plasma level of glucose up to 2 hours Assessed 2 times on each session
Evaluate the subjective effects of DMT up to 2 hours Assessment of the acute subjective effects of DMT, compared to placebo, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects.
Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing up to 1 hours Assessment of the electrical cerebral activity in different bandwidth as beta waves by EEG before, during and after each session.
Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers up to 0.5 hours Assessment of the subacute effects of DMT on EEG, including ERP (event-related potential ) generated from visual and auditory stimulation by applying a visual and auditory perception and imagination task.
Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers up to 0.5 hours Assessment of the acute effects of DMT in ERP (event-related potential) generated from auditory stimulation in an oddball protocol.
Plasma level of cortisol up to 2 hours Assessed 2 times on each session
Plasma level of C-reactive protein (CRP) up to 2 hours Assessed 2 times on each session
Plasma level of urea up to 2 hours Assessed 2 times on each session
Plasma level of creatinine up to 2 hours Assessed 2 times on each session
Plasma level of aspartate transaminase (AST) up to 2 hours Assessed 2 times on each session
Plasma level of subjective effects of DMT up to 2 hours Assessed 2 times on each session
Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing up to 1 hours Assessment of the electrical cerebral activity in different bandwidth as theta waves by EEG before, during and after each session.
Evaluate the influence of expectations up to 0.5 hours Assessment of the influence of expectations variables on subjective experience
Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography up to 50 minutes Evaluate changes in serum DMT concentration over time measured in baseline, 2 and 50 minutes after each session.
Plasma level of alanine transaminase (ALT) up to 2 hours Assessed 2 times on each session
Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing up to 1 hours Assessment of the electrical cerebral activity in different bandwidth as alpha waves by EEG before, during and after each session.
Evaluate the subacute effects of DMT on suggestibility up to 1 hours Assessment of the subacute effects of DMT on suggestibility by applying a suggestibility task named Creative Imagination Scale (CIS). Scores range from 0 to 40. Higher scores indicate more intense suggestibility.
Evaluate the influence of personality trait up to 0.5 hours Assessment of the influence of personality trait on suggestibility
Trial Locations
- Locations (1)
Hospital Universitário Onofre Lopes
🇧🇷Natal, RN, Brazil