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Effects of MDMA and Methylphenidate on Social Cognition

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT01616407
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
8
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: MDMA, methylphenidate, placebo

Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but three treatment conditions in the same subject.

Drug: 3,4-Methylenedioxymethamphetamine
75 mg per os, single dose
Other Names:
  • - MDMA
  • - ecstasy

    • Drug: Methylphenidate
    40 mg per os, single dose
    Other Names:
  • - Ritalin
  • - Concerta

    • Drug: Placebo
    capsules identical to MDMA or methylphenidate but containing no active drug

    Outcome Measures

    Primary Outcome Measures

    1. Effects on social cognition (emotion recognition and empathy) [7 hours]

    Secondary Outcome Measures

    1. Blood pressure (mmHg) and heart rate (beats per min) [7 hours]

    2. Subjective effects [7 hours]

      subjective effects are repetitively assessed by standardized questionnaires

    3. Neuroendocrine plasma levels [7 hours]

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

    4. Drug plasma concentration [7 hours]

      The plasma concentration of MDMA and MPH is repetitively assessed.

    Other Outcome Measures

    1. Genetic polymorphisms [assessed after study completion]

      Effects of genetic polymorphisms on the response to MDMA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel Basel Switzerland 4031

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland

    Investigators

    • Principal Investigator: Matthias E Liechti, MD, University Hospital, Basel, Switzerland

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT01616407
    Other Study ID Numbers:
    • EK 382/11
    • 2012DR1018
    First Posted:
    Jun 11, 2012
    Last Update Posted:
    Dec 11, 2018
    Last Verified:
    Dec 1, 2018
    Keywords provided by University Hospital, Basel, Switzerland
    Effects of psychostimulants on emotion recognition and empathy
    Additional relevant MeSH terms:
    Methylphenidate
    N-Methyl-3,4-methylenedioxyamphetamine

    Study Results

    No Results Posted as of Dec 11, 2018