Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2022-06-01
2022-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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).
N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
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).
N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
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).
N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
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).
N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
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).
N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Interventions
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N,N-Dimethyltryptamine
DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* present proof of vaccination against COVID-19 (Coronavírus)
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Universidade Federal do Rio Grande do Norte
OTHER
Biomind Labs Inc.
INDUSTRY
Responsible Party
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Locations
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Hospital Universitário Onofre Lopes
Natal, Rio Grande do Norte, Brazil
Countries
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Related Links
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Related Info
Other Identifiers
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BMND01
Identifier Type: -
Identifier Source: org_study_id
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