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RECRUITING
NCT07444788
PHASE1

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

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-31

Completion Date

2028-03-01

Last Updated

2026-03-03

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

University Hospital Basel

Basel, Canton of Basel-City, Switzerland