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CompletedEarly Phase 1

Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction

NCT03527316 · MFE · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
30
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Serotonin and oxytocin play a role in fear conditioning and fear extinction learning, psychological processes that are critically involved in psychiatric disorders such as posttraumatic stress disorder (PTSD). Specifically, administration of oxytocin has been shown to facilitate fear extinction in humans. Similarly, substances that release serotonin and oxytocin such as MDMA have been shown to enhance the extinction of fear memory in animals. However, there are no data on the effects of MDMA on fear extinction in humans. Therefore, the primary aim of this study is to investigate the role of acute serotonin release in the effects of fear extinction. MDMA will be used as pharmacological tool to induce serotonin release in this study.

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

  • Fear extinction measured by Skin conductance response

    Measured over 12 months

  • Fear extinction measured by Fear-potentiated startle

    Measured over 12 months

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 50 Years
Ages
MALE
Sex
Accepted
Healthy volunteers
Inclusion Criteria: * Male * Age between 18 and 50 years. * Understanding of the German language. * Understanding the procedures and the risks associated with the study. * Participants must be willing to adhere to the protocol and sign the consent form. * Participants must be willing to refrain from taking illicit psychoactive substances during the study. * Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day. * Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration. * Body mass index 18-29 kg/m2. Exclusion Criteria: * Chronic or acute medical condition * Hypertension (\>140/90 mmHg) or hypotension (SBP\<85 mmHg) * Current or previous major psychiatric disorder * Psychotic disorder in first-degree relatives * Illicit substance use (with the exception of cannabis) of more than 5 times or any time within the previous month. * Participation in another clinical trial (currently or within the last 30 days) * Use of medications that may interfere with the effects of the study medications (any psychiatric medications) * Tobacco smoking (\>10 cigarettes/day) * Consumption of alcoholic standard drinks (\>10/week or \>120 g ethanol/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.

NCT03527316 on ClinicalTrials.gov →

Last updated in the registry 2022-01-19. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits