Clinical TrialHealthy VolunteersMDMAPlaceboCompleted

Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study

Randomised, quadruple-blind, placebo-controlled crossover fMRI study (n=24) administering single doses of methylphenidate 60 mg, modafinil 600 mg, MDMA 125 mg, and placebo to healthy volunteers to assess emotion-processing and cognitive performance.

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

Detailed Description

This placebo-controlled, randomized crossover study enrolled 24 healthy adult volunteers to compare single oral doses of methylphenidate (60 mg), modafinil (600 mg), MDMA (125 mg) and placebo during fMRI to assess drug-specific effects on emotion-processing and social cognition.

Outcomes include task-based fMRI measures of emotion processing, subjective emotional effects and sociability, neurohormonal and cardiovascular responses, and plasma drug concentrations; participants completed separate single-dose sessions with washout between conditions.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Crossover

experimental

Within-subject, randomized, placebo-controlled crossover with four single-dose conditions (methylphenidate, modafinil, MDMA, placebo).

Interventions

  • Compound60 mg
    via Oral• single dose

    Methylphenidate (single 60 mg)

  • Compound600 mg
    via Oral• single dose

    Modafinil (single 600 mg)

  • MDMA125 mg
    via Oral• single dose

    MDMA (single 125 mg)

  • Placebo
    via Oral• single dose

    Placebo capsules matching active drugs

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age between 18 and 45 years
  • Sufficient understanding of the German language
  • Subjects understand 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 including cannabis during the study
  • Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) 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 within 24h following MDMA administration
  • Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.
  • Body mass index: 18-27kg/m2

Exclusion Criteria

  • Exclusion Criteria:
  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90 mmHg) or Hypotension (SBP <85 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder. This also includes contraindications for MRI scanning (any type of implants such as heart pacer, insulin-pump, cochlea-implants, heart valve)
  • Current or previous psychotic or major affective disorder
  • Psychotic or major affective disorder in first-degree relatives
  • Prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 5 times or any time within the previous 2 months
  • Pregnant or nursing women
  • Participation in another clinical trial (currently or within the last 30 days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc.)
  • Tobacco smoking (regularly >10 cigarettes/day)

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment24 participants
  • Timeline
    Start: 2013-01-10
    End: 2014-01-12
  • Compounds
    MDMAPlacebo
  • Topic
    Healthy Volunteers

Locations

University Hospital Basel — Basel, Canton of Basel-City, Switzerland

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