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Acute Subjective Effects, Physiological Effects, and Pharmacokinetics of Intravenous 5-MeO-DMT Infusions in a Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Participants

Participation in this study lasts approximately two weeks and includes three on-site study visits: a screening visit (approximately 2 hours), a study drug administration visit (approximately 4 hours), and a follow-up visit approximately one week later (approximately 2 hours). If participants decide to take part in the study and meet the inclusion and exclusion criteria, they will be randomly assigned to one of two groups: an experimental group or a control group. Participants will not be informed of your group assignment. Participants in the experimental group will receive the investigational substance 5-MeO-DMT at a dose of 0.2, 0.4, 0.6, or 0.8 mg/min for a total infusion duration of 30 min. Participants in the control group will receive a placebo that is indistinguishable in appearance from the investigational substance. Following substance administration, participants will be repeatedly asked to describe their subjective experiences. Blood pressure and heart rate will be monitored regularly, and blood samples will be collected via an intravenous catheter.

Status
recruiting
Phase
Phase 1
Institution
University Hospital, Basel, Switzerland
Principal investigator
Severin Vogt, Dr. med.
Start date
2026-03-31
End date
2028-03-01
Registry ID
NCT07444788

View trial record

Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.