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Effects of MDMA and Methylphenidate on Social Cognition

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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

Study Description
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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
Social Cognition Drug: 3,4-Methylenedioxymethamphetamine Drug: Methylphenidate Drug: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Club Drugs

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Effects on social cognition (emotion recognition and empathy) [ Time Frame: 7 hours ]

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Genetic polymorphisms [ Time Frame: assessed after study completion ]
    Effects of genetic polymorphisms on the response to MDMA


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616407


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E Liechti, MD University Hospital, Basel, Switzerland
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01616407    
Other Study ID Numbers: EK 382/11
2012DR1018 ( Other Identifier: Swissmedic )
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Keywords provided by University Hospital, Basel, Switzerland:
Effects of psychostimulants on emotion recognition and empathy
Additional relevant MeSH terms:
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Methylphenidate
N-Methyl-3,4-methylenedioxyamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Dopamine Agents
Neurotransmitter Agents
Hallucinogens
Psychotropic Drugs
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents