Clinical TrialInterpersonal Functioning & Social ConnectednessMDMAPlaceboPlaceboCompleted

Effects of MDMA and Methylphenidate on Social Cognition

Crossover within-subject study (n=30) in healthy volunteers comparing single oral MDMA (75 mg), methylphenidate (40 mg), and placebo to assess effects on emotional and social cognition.

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Target Enrollment
30 participants
Study Type
Phase I interventional
Design
Non-randomized, quadruple Blind

Detailed Description

Randomised allocation not specified; crossover within-subject design with three single-dose conditions (MDMA 75 mg, methylphenidate 40 mg, placebo) administered on separate sessions to healthy adult volunteers.

Primary aim is basic science: to compare effects on affective perception and social cognition; outcomes include behavioural tests of emotional and social processing and safety/tolerability monitoring.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

MDMA/MPH/placebo

experimental

Crossover within-subject design with three treatment conditions (MDMA, methylphenidate, placebo) tested in each subject.

Interventions

  • MDMA75 mg
    via Oral• single dose• 1 doses total

    Single 75 mg oral dose.

  • Placebo40 mg
    via Oral• single dose• 1 doses total

    Methylphenidate 40 mg (active comparator) — recorded as non-listed compound; name/dose in notes.

  • Placebo
    via Oral• single dose• 1 doses total

    Placebo capsules matching MDMA or methylphenidate.

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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 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. Subjects must agree not to smoke tobacco for 1 h before and 4 hours after MDMA administration.
  • Participants must be willing not to drive a traffic vehicle in the evening of the study day.
  • 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: 18-25 kg/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). Personal or first-grade history of seizures. Cardiac or neurological disorder.
  • Current or previous psychotic or affective disorder
  • Psychotic or affective disorder in first-degree relatives
  • Prior illicit drug use (except 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.)

Study Details

Study Team

Sponsors & Collaborators

Locations

University Hospital Basel — Basel, Switzerland