Safety and Tolerability of DMT in Healthy Adults (NCT05901012) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of DMT in Healthy Adults
Brazil25 participantsStarted 2023-04-26
Plain-language summary
This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Systolic Blood Pressure
Timeframe: up to 2 hours
2
Diastolic Blood Pressure
Timeframe: up to 2 hours
3
Heart rate
Timeframe: up to 2 hours
4
Respiratory rate
Timeframe: up to 2 hours
5
Oxygen saturation
Timeframe: up to 2 hours
Trial details
NCT IDNCT05901012
SponsorUniversidade Federal do Rio Grande do Norte