Actively Recruiting

Phase 1
Age: 25Years - 65Years
All Genders
Healthy Volunteers
NCT07444788

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

Led by University Hospital, Basel, Switzerland · Updated on 2026-03-03

40

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 25Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 sign the consent form
  • Willing to refrain from the use 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 the study participation
  • Body mass index between 18 and 29 kg/m2
Not Eligible

You will not qualify if you...

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Hypertension (SBP >140/90 mmHg) or hypotension (SBP <85 mmHg)
  • Hallucinogenic and/or dissociative substance use (except cannabis) more than 20 times or any time within the previous two months
  • Pregnancy or current breastfeeding
  • Participation in another clinical trial currently or within the last 30 days
  • Use of medication that may interfere with the study medication effects
  • Tobacco smoking more than 10 cigarettes per day
  • Consumption of more than 15 alcoholic drinks or 180g alcohol per week

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Canton of Basel-City, Switzerland, 4056

Actively Recruiting

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Research Team

L

Livio Erne, MSc Drug Sciences

CONTACT

S

Severin B Vogt, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

5

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