NCT05695495

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT BDR-Study).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

Detailed description

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min). However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT bolus doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	N,N-Dimethyltryptamine (5mg)	Intravenous bolus application over 45 seconds
DRUG	N,N-Dimethyltryptamine (10mg)	Intravenous bolus application over 45 seconds
DRUG	N,N-Dimethyltryptamine (15mg)	Intravenous bolus application over 45 seconds
DRUG	N,N-Dimethyltryptamine (20mg)	Intravenous bolus application over 45 seconds
DRUG	N,N-Dimethyltryptamine (25mg)	Intravenous bolus application over 45 seconds
DRUG	Placebo (saline)	Intravenous bolus application over 45 seconds

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-02-02
• Completion: 2025-03-04
• First posted: 2023-01-25
• Last updated: 2025-04-11

Locations

1 site across 1 country: Switzerland