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

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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

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.


Condition or disease Intervention/treatment Phase
Healthy Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Drug: Naltrexone Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study
Study Start Date : October 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2017


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reaction Time on the Multi-Source Interference Task [ Time Frame: Two hours ]
    Reaction time of the Multi-Source Interference Task is measured in seconds.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01993108


Locations
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United States, Michigan
Rachel Upjohn Building, East Medical Campus
Ann Arbor, Michigan, United States, 48109-2700
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Chandra Sekhar Sripada, MD, PhD University of Michigan

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Responsible Party: Chandra Sekhar Sripada, Assistant Professor of Psychiatry at the University of Michigan, University of Michigan
ClinicalTrials.gov Identifier: NCT01993108     History of Changes
Other Study ID Numbers: HUM00047129
First Posted: November 25, 2013    Key Record Dates
Results First Posted: June 18, 2018
Last Update Posted: June 18, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chandra Sekhar Sripada, University of Michigan:
Methylphenidate
Naltrexone
Placebo
Neuroimaging
Prefrontal Control Circuits
Attention Control
Motor Control
Appetitive Control
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Naltrexone
Methylphenidate
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents