Clinical trial NCT05573568: Clinical Study of DMT in Healthy Adults
Official title: Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: N,N-DMT
DMT
N,N-Dimethyltryptamine
Healthy Volunteers
Lead sponsor: Biomind Labs Inc.
Sponsor class: INDUSTRY
Collaborators: name: Universidade Federal do Rio Grande do Norte
First posted: 2022-10-10
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation
timeFrame: up to 1 month after dosing
measure: Blood Pressure
timeFrame: up to 2 hours after each dose
measure: Heart rate
timeFrame: up to 2 hours after each dose
measure: Respiratory rate
timeFrame: up to 2 hours after each dose
measure: Oxygen saturation
timeFrame: up to 2 hours after each dose
Secondary outcomes:
measure: Plasma level of glucose
timeFrame: up to 2 hours after each dose
measure: Plasma level of total cholesterol
timeFrame: up to 2 hours after each dose
measure: Plasma level of C-reactive protein (CRP)
timeFrame: up to 2 hours after each dose
measure: Plasma level of urea
timeFrame: up to 2 hours after each dose
measure: Plasma level of creatinine
timeFrame: up to 2 hours after each dose
measure: Plasma level of aspartate transaminase (AST)
timeFrame: up to 2 hours after each dose
measure: Plasma level of alanine transaminase (ALT)
timeFrame: up to 2 hours after each dose
measure: Plasma level of cortisol
timeFrame: up to 2 hours after each dose
measure: Evaluate the subjective effects of DMT
timeFrame: up to 2 hours after each dose
measure: Evaluate acute effects on cerebral activity using electroencephalography before, during and after the dosing
timeFrame: up to 2 hours after each dose
measure: Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography
timeFrame: up to 2 hours after each dose
measure: Evaluate the impact of after DMT on satisfaction with life using scale
timeFrame: up to 1 month after dosing
measure: Evaluate the impact of DMT on trait and state of anxiety using scale
timeFrame: up to 1 month after dosing
measure: Evaluate the impact of DMT on quality of life using scale
timeFrame: up to 1 month after dosing
measure: Evaluate the impact of DMT on spirituality, religiousness and personal beliefs
timeFrame: up to 1 month after dosing
measure: Evaluate the impact of DMT on affect using scale
timeFrame: up to 1 month after dosing
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Hospital Universitário Onofre Lopes
state: Rio Grande Do Norte
Study officials:
References: