drugset / Trial / NCT07444788

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

NCT07444788

Phase 1 Recruiting 40 enrolled University Hospital, Basel, Switzerland
RandomizedParallel-groupQuadruple-blindOther

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.

Timeline

Start
2026-03-31
Primary completion
2028-03-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mebufotenin Small molecule 6 mg Intravenous
Subject Mebufotenin Small molecule 12 mg Intravenous
Subject Mebufotenin Small molecule 18 mg Intravenous
Subject Mebufotenin Small molecule 24 mg Intravenous

Indications

No indication recorded.