CompletedPhase 1

Effects of Dimethyltryptamine in Healthy Subjects

NCT04353024 · DMT · University Hospital, Basel, Switzerland

Closed to entry

Status

Not accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings. DMT can be used as a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (\<20 min).Therefore, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience allowing to study the psychological and autonomic acute effects of DMT. This administration allows to induce and end an altered state safely and quickly. The goal of the present study is to experimentally test different intravenous DMT administration schedules to investigate the subjective and autonomic effects of DMT in healthy subjects.

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

Altered states of consciousness profile
Measured over 150 minutes
Subjective effect ratings over time
Measured over 150 minutes

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: * 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 * Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions * Willing not to operate heavy machinery within 6 h of DMT administration * Willing to use double-barrier 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 * Psychotic disorder or bipolar disorder in first-degree relatives * Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) * Hallucinogenic substance use (not including 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 effects of the study medication * Tobacco smoking (\>10 cigarettes/day) * Consumption of alcoholic beverages (\>20 drinks/week)

Where

1 study site

Facility	City	Region	Country
University Hospital Basel	Basel	Basel-Stadt BS	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.

NCT04353024 on ClinicalTrials.gov →

Last updated in the registry 2022-10-12. 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 →