NCT05829603

Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects

Single-blind, Randomized, Two-arm, Dose-response Study of DMT and Harmine in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Reconnect Labs · Industry
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety \& tolerability.

Detailed description

Participants will undergo a series of six study days with varying doses of DMT and Harmine. The intervention is embedded in controlled environment and continuous psychological support. Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 24 hours on each study visit to estimate dose-exposure relationship and drug-drug-interaction. Additionally, the occurrence of adverse events will be closely monitored throughout the whole study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Dimethyltryptamin (DMT) & Harmine	Six varying doses of a fixed-combination formulation of Dimethyltryptamin (DMT) and harmine

Timeline

• Start date: 2023-05-05
• Primary completion: 2023-09-17
• Completion: 2023-10-17
• First posted: 2023-04-25
• Last updated: 2023-11-02

Locations

1 site across 1 country: Switzerland