NCT05573568

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

October 6, 2022

Last Update Submit

February 13, 2023

Conditions

Healthy Volunteers

Keywords

N,N-DMTDMTN,N-DimethyltryptamineHealthy Volunteers

Outcome Measures

Primary Outcomes (5)

  • Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation

    Evaluate clinical and psychiatry acute risks after DMT treatments assessed by qualitative medical evaluation after dosing.

    up to 1 month after dosing

  • Blood Pressure

    Assessed 20 times on each dose via systolic and diastolic blood pressure

    up to 2 hours after each dose

  • Heart rate

    Assessed 20 times on each dose

    up to 2 hours after each dose

  • Respiratory rate

    Assessed 20 times on each dose

    up to 2 hours after each dose

  • Oxygen saturation

    Assessed 20 times on each dose

    up to 2 hours after each dose

Secondary Outcomes (16)

  • Plasma level of glucose

    up to 2 hours after each dose

  • Plasma level of total cholesterol

    up to 2 hours after each dose

  • Plasma level of C-reactive protein (CRP)

    up to 2 hours after each dose

  • Plasma level of urea

    up to 2 hours after each dose

  • Plasma level of creatinine

    up to 2 hours after each dose

  • +11 more secondary outcomes

Study Arms (5)

Group A - single ascending dose

EXPERIMENTAL

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).

Drug: N,N-Dimethyltryptamine

Group B - single ascending dose

EXPERIMENTAL

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).

Drug: N,N-Dimethyltryptamine

Group C - single ascending dose

EXPERIMENTAL

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).

Drug: N,N-Dimethyltryptamine

Group D - single ascending dose

EXPERIMENTAL

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).

Drug: N,N-Dimethyltryptamine

Group E - single ascending dose

EXPERIMENTAL

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).

Drug: N,N-Dimethyltryptamine

Interventions

N,N-DimethyltryptamineDRUG

DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen

Also known as: DMT, BMND01
Group A - single ascending doseGroup B - single ascending doseGroup C - single ascending doseGroup D - single ascending doseGroup E - single ascending dose

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • prior experience with N,N-Dimethyltryptamine (DMT)
  • present proof of vaccination against COVID-19 (Coronavírus)

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitário Onofre Lopes

Natal, Rio Grande do Norte, 59012300, Brazil

Location

Related Links

MeSH Terms

Interventions

N,N-Dimethyltryptamine

Intervention Hierarchy (Ancestors)

TryptaminesBiogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2022

First Posted

October 10, 2022

Study Start

June 1, 2022

Primary Completion

November 1, 2022

Study Completion

November 14, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)