NCT05384678

Acute Dose-dependent Effects of DMT in Healthy Subjects

Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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 continuous intravenous DMT dose rates 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). In Ayahuasca, DMT is consumed together with harmala alkaloids that inhibit MAO to increase the oral bioavailablitity of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience and is currently being investigated. 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 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 (54 mg)	A dose rate of 0.6 mg/min will be administered
DRUG	N,N-Dimethyltryptamine (108 mg)	A dose rate of 1.2 mg/min will be administered
DRUG	N,N-Dimethyltryptamine (162 mg)	A dose rate of 1.8 mg/min will be administered
DRUG	N,N-Dimethyltryptamine (216 mg)	A dose rate of 2.4 mg/min will be administered
DRUG	Placebo	A Placebo (saline infusion) will be administered.
DRUG	N,N-Dimethyltryptamine (108 mg) + dose titration	A dose rate of 1.2 mg/min will be administered with subsequent patient-guided dose titration

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-03-08
• Completion: 2024-03-13
• First posted: 2022-05-20
• Last updated: 2024-04-25

Locations

1 site across 1 country: Switzerland