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Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study

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ClinicalTrials.gov Identifier: NCT01951508
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE September 23, 2013
First Posted Date  ICMJE September 26, 2013
Last Update Posted Date January 21, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Effect on amygdala and striatum BOLD signal responses to emotional stimuli [ Time Frame: 1.5h ]
    Functional magnetic resonance (MR) images measuring BOLD (blood oxygen level dependency)activity while subjects will be presented with a series of images of human faces, each showing a fearful or a neutral expression, in an event-related design.
  • Effects on cognitive performance and associated BOLD signal changes in frontal areas [ Time Frame: 1.5h ]
    Functional magnetic resonance (MR) images measuring BOLD (blood oxygen level dependency)activity while subjects perform a response inhibition/attention task.
Original Primary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
  • Effect on amygdala and striatum BOLD signal responses to emotional stimuli [ Time Frame: 1.5h ]
  • Effects on cognitive performance and associated BOLD signal changes in frontal areas [ Time Frame: 1.5h ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2013)
  • Subjective effects [ Time Frame: 7h ]
    repeated assessment of subjective effects with validated, standardized questionnaires
  • Neuroendocrine effects [ Time Frame: 7h ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, copeptin
  • Empathy and social behavior [ Time Frame: 7h ]
    assessment of cognitive and emotional empathy (empathy is going to be assessed by the Multifaceted Empathy Test (MET)), facial emotion recognition (assessed by the Facial Emotion Recognition Task (FERT)), and prosocial behavior (assessed with the Social Value Orientation Test (SVO)). , as well as of prosocial behaviour
  • Physiological effects of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    repeated assessment of blood pressure (mmHg) , heart rate (bpm), body temperature, and pupillary function
  • Genetic Polymorphisms [ Time Frame: 1 day (assessed once after study completion) ]
    Effects of genetic polymorphisms on the response to methylphenidate, modafinil, and MDMA
  • Pharmacokinetics of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship
Original Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
  • Subjective effects [ Time Frame: 7h ]
    repeated assessment of subjective effects with validated questionnaires
  • Neuroendocrine effects [ Time Frame: 7h ]
  • Empathy and social behavior [ Time Frame: 7h ]
    assessment of cognitive and emotional empathy, as well as of prosocial behaviour
  • Physiological effects of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    Effect on blood pressure, heart rate, body temperature, and pupillary function
  • Genetic Polymorphisms [ Time Frame: 1 day (assessed once after study completion) ]
    Effects of genetic polymorphisms on the response to methylphenidate, modafinil, and MDMA
  • Pharmacokinetics of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
Official Title  ICMJE Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
Brief Summary The purpose of this study is to investigate effects of methylphenidate, modafinil, and 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") on emotion-processing and cognitive performance using functional magnetic resonance imaging (fMRI) techniques. The primary hypothesis is that these psychostimulants differentially affect processing of emotional stimuli and potentially leading to alterations in social cognition and behavior.
Detailed Description Methylphenidate and modafinil are increasingly used as performance enhancers or "smart drugs" by students. 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy") is widely used as recreational drug to enhance emotions. We plan to investigate effects of these psychostimulants on emotion-processing and cognitive performance using functional magnetic resonance imaging (fMRI) techniques. Single doses of methylphenidate (60mg), modafinil (600mg), MDMA (125mg), or placebo will be administered before an fMRI scan in a placebo-controlled, randomized cross-over study design in 24 healthy subjects. Subjective emotional effects, sociability, neurohormonal, cardiovascular responses, and plasma drug concentrations will also be assessed and analyzed for potential brain-induced changes in brain activity in networks processing emotions. The primary hypothesis is that these psychostimulants differentially affect processing of emotional stimuli and potentially leading to alterations in social cognition and behavior. The work should clarify the neuropharmacological basis of the potentially differential effects of these drugs. This information will improve our understanding of the neurofunctional effects of methylphenidate, modafinil, and MDMA, and inform the ongoing debate surrounding brain doping with cognitive and mood enhancers.
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
  • Healthy
  • Substance-related Disorder
  • Mood Disorder
Intervention  ICMJE
  • Drug: Methylphenidate
    60mg per os, single dose
    Other Names:
    • Ritalin
    • Concerta
    • Medikinet
    • Focalin
  • Drug: Modafinil
    600mg per os, single dose
    Other Name: Modasomil
  • Drug: MDMA
    125mg per os, single dose
    Other Names:
    • 3,4-Methylenedioxymethamphethamine
    • Ecstasy
  • Drug: Placebo
    per os
    Other Name: capsules containing manitol looking identical to methylphenidate, modafinil, and MDMA
Study Arms  ICMJE Methylphenidate, Modafinil, MDMA, Placebo
Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but four treatment conditions in the same subject.
Interventions:
  • Drug: Methylphenidate
  • Drug: Modafinil
  • Drug: MDMA
  • Drug: Placebo
Publications *

*   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: September 25, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age between 18 and 45 years
  • 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 including cannabis 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, as well as during the study day
  • Participants must be willing not to drive a traffic vehicle within 24h following MDMA administration
  • 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: 18-27kg/m2

Exclusion Criteria:

  • Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (>140/90mmgHg) or Hypotension (SBP<85mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder. This also includes contraindications for MRI scanning (any type of implants such as heart pacer, insulin-pump, cochlea-implants, heart valve)
  • Current or previous psychotic or major affective disorder
  • Psychotic or major affective disorder in first-degree relatives
  • Prior illicit drug use (except tetrahydrocannabinol (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 30days)
  • Use of medications that are contraindicated or otherwise interfere with the effects of the study medications (monoamine oxidase inhibitors, antidepressants, sedatives etc. )
  • Tobacco smoking (regularly > 10cigarettes / day)
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 NCT01951508
Other Study ID Numbers  ICMJE EK 36/13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date January 2016

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