RecruitingPhase 1

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

NCT07444788 · MEOS · University Hospital, Basel, Switzerland

Recruiting

Status

Accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in subjective effects over time (assessed with subjective effect scales (SES))
Measured over 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.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years

Ages

All

Sex

Accepted

Healthy volunteers

Inclusion Criteria: 1. Age between 25 and 65 years old 2. Sufficient understanding of the German language 3. Understanding of procedures and risks associated with the study 4. Willing to adhere to the protocol and signing of the consent form 5. Willing to refrain from the consumption of illicit psychoactive substances during the study 6. Willing not to operate heavy machinery for 48 hours after the study session. 7. Willing to use effective birth control throughout study participation 8. Body mass index between 18-29 kg/m2 Exclusion Criteria: 1. Chronic or acute medical condition 2. Current or previous major psychiatric disorder 3. Psychotic disorder or bipolar disorder in first-degree relatives 4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) 5. Hallucinogenic and/or dissociative substance use (not including cannabis) more than 20 times or any time within the previous two months 6. Pregnancy or current breastfeeding 7. Participation in another clinical trial (currently or within the last 30 days) 8. Use of medication that may interfere with the effects of the study medication 9. Tobacco smoking (\>10 cigarettes/day) 10. Consumption of alcoholic beverages (\>15 drinks or \>180g alcohol per week)

Where

1 study site

Facility	City	Region	Country
University Hospital Basel	Basel	Canton of Basel-City	Switzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07444788 on ClinicalTrials.gov →

Last updated in the registry 2026-03-03. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

All 48 trials from University Hospital, Basel, Switzerland →