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CompletedPhase 1

Acute Dose-dependent Effects of DMT-bolus Applications in Healthy Subjects (DMT BDR-Study)

NCT05695495 · DMT BDR · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
36
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different intravenous DMT boluses over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.

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 (OAV)

    Measured over Repeatedly 1 hour after each bolus application

  • Subjective effect ratings over time

    Measured over Repeatedly 1 hour after each bolus application

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. Abstaining from xanthine-based liquids from the evenings prior to the study sessions and during the sessions 7. Willing not to operate heavy machinery within 6 h of DMT administration 8. Willing to use double-barrier birth control throughout study participation 9. Body mass index between 18-29 kg/m2. Exclusion Criteria: 1. Chronic or acute medical condition 2. Current or previous major psychiatric disorder (e.g. psychotic disorders, mania / hypomania, anxiety disorders). 3. Psychotic disorder or bipolar disorder in first-degree relatives 4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg) 5. Hallucinogenic 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 (\>20 drinks/week)

Where

1 study site

FacilityCityRegionCountry
Clinical Pharmacology & Toxicology, University Hospital BaselBaselSwitzerland

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.

NCT05695495 on ClinicalTrials.gov →

Last updated in the registry 2025-04-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits