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

Study acronym: MEOS
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion moved earlier from Mar 1, 2028 to Mar 1, 2027 Show 4 more changesShow less
    • Start date changed from estimate of Mar 31, 2026 to Aug 13, 2026
    • Interventions: 0.2 mg/min 5-MeO-DMT (Drug), 0.4 mg/min 5-MeO-DMT (Drug), 0.6 mg/min 5-MeO-DMT (Drug), 0.8 mg/min 5-MeO-DMT (Drug), Placebo (Drug) to 0.2 mg/min 5-MeO-DMT (Drug), 0.4 mg/min 5-MeO-DMT (Drug), 0.6 mg/min 5-MeO-DMT (Drug), 0.8 mg/min 5-MeO-DMT (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 20 of 23 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07444788
Lead Sponsor University Hospital, Basel, Switzerland
Conditions
(from sponsor)		 5-methoxy-dimethyltryptamine (5-MeO-DMT)
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov