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

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

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.

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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  lead OTHER

Principal Investigators

• Severin Vogt, Dr. med. · University Hospital Basel, Division of Clinical Pharmacology and Toxicology

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2028-03-01

Completion

2028-03-01

Countries

• Switzerland

Study Locations