Effect of Methylenedioxymethamphetamine (MDMA)... — Clinical Trial Details

Double-blind, randomised, within-subject crossover in healthy male volunteers (n=30) comparing a single oral dose of MDMA 125 mg with matching placebo to assess effects on fear extinction.

Primary purpose is basic science: using MDMA as a pharmacological tool to induce acute serotonin release and examine its role in fear conditioning and extinction; outcomes include behavioural extinction measures and related psychophysiology.

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)

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Effects of 3,4-Methylenedioxymethamphetamine on Conditioned Fear Extinction and Retention in a Crossover Study in Healthy Subjects

Integration

Study Arms & Interventions

MDMA vs Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators