NCT07444788

Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• 5-methoxy-dimethyltryptamine (5-MeO-DMT)

Interventions

Type	Name	Description
DRUG	0.2 mg/min 5-MeO-DMT	0.2 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
DRUG	0.4 mg/min 5-MeO-DMT	0.4 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
DRUG	0.6 mg/min 5-MeO-DMT	0.6 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
DRUG	0.8 mg/min 5-MeO-DMT	0.8 mg/min 5-MeO-DMT will be administered intravenously for a total infusion duration of 30 min.
DRUG	Placebo	Placebo (saline) is administered for a total infusion duration of 30 min.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: Switzerland