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CompletedPhase 1

Acute Effects of 3,4-methylenedioxymethamphetamine (MDMA) With and Without a Booster Dose

NCT05809271 · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
25
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

3,4-methylenedioxymethamphetamine (MDMA) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. The current study investigates differences in duration of acute effects and side effects after administration of a single dose of MDMA compared to a repeated administration.

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

  • Subjective effect duration for "any drug effect"

    Measured over Every 15 minutes for 9 hours 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

18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria: 1. Good understanding of the German language. 2. Understanding the procedures and the risks that are associated with the study. 3. Participants must be willing to adhere to the protocol and sign the consent form. 4. Participants must be willing to refrain from taking illicit psychoactive substances during the study. 5. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drinks after midnight of the evening before the study session, as well as during the study day. 6. Participants must be willing not to drive a traffic vehicle or to operate machines within 48h after substance administration. 7. Willing to use effective birth control throughout study participation. 8. Body mass index between 18-29 kg/m2. Exclusion Criteria: 1. Relevant chronic or acute medical condition. 2. Current or previous major psychiatric disorder. 3. Psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain. 4. Hypertension (SBP\>140/90 mmHg) or hypotension (SBP\<85 mmHg). 5. Previous MDMA use more than 20 times or any time within the previous month. 6. Pregnant or nursing women. 7. Participation in another clinical trial (currently or within the last 30 days). 8. Use of medications that may interfere with the effects of the study medications. 9. Tobacco smoking (\>10 cigarettes/day). 10. Consumption of alcoholic drinks (\>15 drinks/week).

Where

1 study site

FacilityCityRegionCountry
University HospitalBaselSwitzerland

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.

NCT05809271 on ClinicalTrials.gov →

Last updated in the registry 2025-03-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits