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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

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.

Condition or disease Intervention/treatment Phase
Healthy Substance-related Disorder Mood Disorder Drug: Methylphenidate Drug: Modafinil Drug: MDMA Drug: Placebo Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study
Study Start Date : October 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Subjective effects [ Time Frame: 7h ]
    repeated assessment of subjective effects with validated, standardized questionnaires

  2. Neuroendocrine effects [ Time Frame: 7h ]
    neuroendocrine parameters assessed: prolactin, cortisol, epinephrine, norepinephrine, oxytocin, copeptin

  3. 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


  4. Physiological effects of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    repeated assessment of blood pressure (mmHg) , heart rate (bpm), body temperature, and pupillary function

  5. Genetic Polymorphisms [ Time Frame: 1 day (assessed once after study completion) ]
    Effects of genetic polymorphisms on the response to methylphenidate, modafinil, and MDMA

  6. Pharmacokinetics of methylphenidate, modafinil, and MDMA [ Time Frame: 7h ]
    Time course of plasma concentration, half-life, pharmacokinetic-pharmacodynamic relationship



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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)

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): NCT01951508


Locations
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Switzerland
University Hospital Basel
Basel, Basel-Stadt, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland

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: NCT01951508    
Other Study ID Numbers: EK 36/13
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by University Hospital, Basel, Switzerland:
Methylphenidate
Modafinil
MDMA
fMRI
emotion-processing
social cognition
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Mood Disorders
Pathologic Processes
Mental Disorders
Chemically-Induced Disorders
Methylphenidate
Modafinil
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
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Hallucinogens
Psychotropic Drugs
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents