NCT05901012

Safety and Tolerability of DMT in Healthy Adults

Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Universidade Federal do Rio Grande do Norte · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety Issues
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	N,N-Dimethyltryptamine	DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.
DRUG	Placebo	DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.

Timeline

• Start date: 2023-04-26
• Primary completion: 2023-07-17
• Completion: 2023-07-17
• First posted: 2023-06-13
• Last updated: 2023-10-11

Locations

1 site across 1 country: Brazil