Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants (NCT07444788) | Clinical Trial Compass
RecruitingPhase 1
Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants
Switzerland40 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range25 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age between 25 and 65 years old
✓. Sufficient understanding of the German language
✓. Understanding of procedures and risks associated with the study
✓. Willing to adhere to the protocol and signing of the consent form
✓. Willing to refrain from the consumption of illicit psychoactive substances during the study
✓. Willing not to operate heavy machinery for 48 hours after the study session.
✓. Willing to use effective birth control throughout study participation
✓. Body mass index between 18-29 kg/m2
Exclusion criteria
✕. Chronic or acute medical condition
✕. Current or previous major psychiatric disorder
✕
What they're measuring
1
Change in subjective effects over time (assessed with subjective effect scales (SES))
Timeframe: Up to 245 minutes at the substance administration session (Session 2): 1 hour and 5 minutes before and 5, 10, 15, 20, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 min after substance administration.