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Completed

NCT Number: NCT01616407

Effects of MDMA and Methylphenidate on Social Cognition

The purpose of this study is to assess and compare the effects of a single dose of 3,4-methylenedioxymethamphetamine (MDMA)and methylphenidate (MPH) on emotional and social cognition in healthy subjects. The investigators hypothesize that MDMA enhances affective perception for positive and impairs perception for negative emotional stimuli compared to placebo or MPH.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.)

Treatment and study plan

3,4-methylenedioxymethamphetamine

Drug

75 mg per os, single dose

Other names: - MDMA, - ecstasy

Methylphenidate

Drug

40 mg per os, single dose

Other names: - Ritalin, - Concerta

Placebo

Drug

capsules identical to MDMA or methylphenidate but containing no active drug

Primary outcomes

  1. Effects on social cognition (emotion recognition and empathy)

    Time frame: 7 hours

Secondary outcomes

  1. Blood pressure (mmHg) and heart rate (beats per min)

    Time frame: 7 hours

  2. Subjective effects

    Time frame: 7 hours

    subjective effects are repetitively assessed by standardized questionnaires

  3. Neuroendocrine plasma levels

    Time frame: 7 hours

    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone

  4. Drug plasma concentration

    Time frame: 7 hours

    The plasma concentration of MDMA and MPH is repetitively assessed.

Other outcomes

  1. Genetic polymorphisms

    Time frame: assessed after study completion

    Effects of genetic polymorphisms on the response to MDMA

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jun 11, 2012
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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