Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

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

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.

Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

MDMA vs Placebo

experimental

Within-subject crossover comparing single oral MDMA 125 mg with matching mannitol placebo; conditions separated by washout.

Interventions

  • MDMA125 mg
    via Oral• single dose• 1 doses total
  • Placebo
    via Oral• single dose

    Mannitol capsules matching MDMA

Participants

Ages
18 – 50
Sexes
male

Inclusion Criteria

  • 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

  • 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)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment30 participants
  • Timeline
    Start: 2019-10-18
    End: 2020-12-24
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

Clinical Pharmacology & Toxicology, University Hospital Basel — Basel, Switzerland

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