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Effects of MDMA and Methylphenidate on Social Cognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01616407
Recruitment Status : Completed
First Posted : June 11, 2012
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE June 7, 2012
First Posted Date  ICMJE June 11, 2012
Last Update Posted Date December 11, 2018
Study Start Date  ICMJE August 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
Effects on social cognition (emotion recognition and empathy) [ Time Frame: 7 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2012)
  • Blood pressure (mmHg) and heart rate (beats per min) [ Time Frame: 7 hours ]
  • Subjective effects [ Time Frame: 7 hours ]
    subjective effects are repetitively assessed by standardized questionnaires
  • Neuroendocrine plasma levels [ Time Frame: 7 hours ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, pro-vasopressin, vasopressin, estrogene,and progesterone
  • Drug plasma concentration [ Time Frame: 7 hours ]
    The plasma concentration of MDMA and MPH is repetitively assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 17, 2013)
Genetic polymorphisms [ Time Frame: assessed after study completion ]
Effects of genetic polymorphisms on the response to MDMA
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of MDMA and Methylphenidate on Social Cognition
Official Title  ICMJE Effects of MDMA (Ecstasy) and Methylphenidate (Ritalin) on Social Cognition
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Social Cognition
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: 3,4-Methylenedioxymethamphetamine
  • Drug: Methylphenidate
  • Drug: Placebo
Publications * Schmid Y, Hysek CM, Simmler LD, Crockett MJ, Quednow BB, Liechti ME. Differential effects of MDMA and methylphenidate on social cognition. J Psychopharmacol. 2014 Sep;28(9):847-56. doi: 10.1177/0269881114542454. Epub 2014 Jul 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01616407
Other Study ID Numbers  ICMJE EK 382/11
2012DR1018 ( Other Identifier: Swissmedic )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Matthias Liechti, University Hospital, Basel, Switzerland, PD Dr. med., MAS
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP