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Trial record 51 of 441 for:    Methylphenidate

Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS)) (NMAS)

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: NCT01993108
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chandra Sekhar Sripada, University of Michigan

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE March 20, 2018
Results First Posted Date  ICMJE June 18, 2018
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE October 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Reaction Time Variability on the Multi-Source Interference Task [ Time Frame: 2 hours ]
Multi-Source Interference Task is a psychological task that measures the psychological construct of cognitive control, the ability to suppress automatic response tendencies. Reaction time variability is the standard deviation of the trial to trial reaction time measured in seconds.
Original Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • Identify abnormalities in prefrontal control neural circuits underlying attention control, motor control, and appetitive control [ Time Frame: Two years ]
  • Characterize effects of methylphenidate and naltrexone on neural circuits in prefrontal cortex associated with attention control, motor control, and appetitive control [ Time Frame: Two years ]
    We will characterize effects of methylphenidate and naltrexone by the change in BOLD (Blood Oxygen Level Dependent signal which is the signal that is measured by fMRI [functional magnetic resonance imaging]) activation in dorsal lateral prefrontal cortex, anterior insula anterior cingulate in the incongruent condition (cognitive regulation condition) of the MSIT (mulit-source interference task) relative to the congruent condition (no regulation condition).
Change History Complete list of historical versions of study NCT01993108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
  • Reaction Time on the Multi-Source Interference Task [ Time Frame: Two hours ]
    Reaction time of the Multi-Source Interference Task is measured in seconds.
  • Accuracy on the Multi-Source Interference Task [ Time Frame: Two hours ]
    Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.
  • Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control. [ Time Frame: Two hours ]
    The effects of methylphenidate, naltrexone, and placebo on the change in BOLD (Blood Oxygen Level Dependent) signal will be characterized in the incongruent condition (cognitive regulation condition) of the MSIT (multi-source interference task) relative to the congruent condition (no regulation condition). Specifically, the summed BOLD signal in three regions--dorsal lateral prefrontal cortex, anterior insula, anterior cingulate--are measured.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • Reaction Time on the Multi-Source Interference Task [ Time Frame: Two years ]
  • Accuracy on the Multi-Source Interference Task [ Time Frame: Two years ]
    Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.
  • Reaction time variability on the Multi-Source Interference Task [ Time Frame: Two years ]
    Reaction time variability is the standard deviation of the trial to trial reaction time distribution (the standard deviation is a unitless quantity) on the Multi-Source Interference Task.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
Official Title  ICMJE Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study
Brief Summary

The goal of this research is to understand the functioning of 'regulatory circuits' in the brain. We are also interested in how the medications methylphenidate and naltrexone affect these regulatory circuits. This research study will use a scanning technique known as functional magnetic resonance imaging (fMRI) which takes a special kind of picture of the brain that enables us to "see the brain at work". Adult participants will be given a one-time dose of either methylphenidate, naltrexone,or placebo before each fMRI scan session.

The main purpose for this research is to better understand the functioning of regulatory circuits in healthy individuals and individuals with psychiatric disorders. This research may one day help us develop better treatments for these disorders.

Detailed Description

The goal of this research is to understand the functioning of 'regulatory circuits' in the brain. These are brain circuits which allow a person to regulate their attention, regulate their behavioral responses, and regulate their decision-making. We are also interested in how the medications methylphenidate and naltrexone affect these regulatory circuits. Methylphenidate is a widely-used, FDA approved medication used to treat Attention Deficit Hyperactivity Disorder (ADHD) and is also known as Ritalin. Naltrexone is an FDA approved medication used to help treat alcohol and substance abuse.

This research study will use a scanning technique known as functional magnetic resonance imaging (fMRI)which takes a special kind of picture of the brain that enables us to "see the brain at work". Adult participants will be given a one-time dose of either methylphenidate, naltrexone,or placebo before each fMRI scan session. There are three total fMRI scan sessions. Therefore, each participant will receive each possible medication/placebo only once.

Using the fMRI technique, the main purpose of this research is to better understand the functioning of regulatory circuits in healthy individuals and individuals with psychiatric disorders. This research may one day help us develop better treatments for these disorders.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • Drug: Methylphenidate
    One dose 40mgs of methylphenidate one hour before fMRI scanning.
    Other Name: Ritalin
  • Drug: Naltrexone
    One dose 40mgs of naltrexone one hour before fMRI scanning.
    Other Name: ReVia
  • Drug: Placebo
    One dose of placebo one hour before fMRI scanning.
    Other Name: sugar pill
Study Arms  ICMJE
  • Experimental: Healthy Controls
    Healthy individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
    Interventions:
    • Drug: Methylphenidate
    • Drug: Naltrexone
    • Drug: Placebo
  • Experimental: Adult Attention-Deficit/Hyperactivity Disorder
    ADHD individuals will receive a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session.
    Interventions:
    • Drug: Methylphenidate
    • Drug: Naltrexone
    • Drug: Placebo
Publications * Not Provided

*   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: May 17, 2018)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
160
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for all study participants:

  • Right-Handedness

Exclusion Criteria for all study participants:

  • Any clinically significant history of cardiac problems
  • Any current Axis I psychiatric diagnosis as verified by the Structured Clinical Interview for DSM-IV (other than participants with ADHD or history of alcohol dependence)
  • A previous adequate trial with methylphenidate (Ritalin) or naltrexone (ReVia)
  • Currently taking any psychoactive medications
  • Any clinically significant medical condition
  • Any clinically significant neurological problem (seizures, tics, serious head injury)
  • Contraindications to MRI (metal objects in body or claustrophobia)
  • Currently pregnant or lactating
  • Alcohol or substance abuse (current or in the past 2 years)
  • Left-handedness or ambidextrous
  • Liver or kidney disease

Inclusion Criteria for the participants with ADHD:

  • Currently un-medicated adults with ADHD
  • Has met full DSM-IV-R criteria (at least six of nine symptoms)for inattentive or hyperactive/impulsive subtypes (or both) by age 7 as well within the past month
  • Has described a chronic course of ADHD symptomatology from childhood to adulthood
  • Has endorsed a moderate or severe level of impairment attributed to the ADHD symptoms
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993108
Other Study ID Numbers  ICMJE HUM00047129
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chandra Sekhar Sripada, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chandra Sekhar Sripada, MD, PhD University of Michigan
PRS Account University of Michigan
Verification Date May 2018

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