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

Primary Purpose

Healthy, Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
Naltrexone
Placebo
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Methylphenidate, Naltrexone, Placebo, Neuroimaging, Prefrontal Control Circuits, Attention Control, Motor Control, Appetitive Control

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rachel Upjohn Building, East Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Controls

Adult Attention-Deficit/Hyperactivity Disorder

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reaction Time Variability on the Multi-Source Interference Task
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

Reaction Time on the Multi-Source Interference Task
Reaction time of the Multi-Source Interference Task is measured in seconds.
Accuracy on the Multi-Source Interference Task
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.
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.

Full Information

First Posted
November 13, 2013
Last Updated
May 17, 2018
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01993108
Brief Title
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
Acronym
NMAS
Official Title
Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Attention Deficit Hyperactivity Disorder
Keywords
Methylphenidate, Naltrexone, Placebo, Neuroimaging, Prefrontal Control Circuits, Attention Control, Motor Control, Appetitive Control

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
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.
Arm Title
Adult Attention-Deficit/Hyperactivity Disorder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
One dose 40mgs of methylphenidate one hour before fMRI scanning.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
ReVia
Intervention Description
One dose 40mgs of naltrexone one hour before fMRI scanning.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
One dose of placebo one hour before fMRI scanning.
Primary Outcome Measure Information:
Title
Reaction Time Variability on the Multi-Source Interference Task
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Reaction Time on the Multi-Source Interference Task
Description
Reaction time of the Multi-Source Interference Task is measured in seconds.
Time Frame
Two hours
Title
Accuracy on the Multi-Source Interference Task
Description
Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task.
Time Frame
Two hours
Title
Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.
Description
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.
Time Frame
Two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandra Sekhar Sripada, MD, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rachel Upjohn Building, East Medical Campus
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2700
Country
United States

12. IPD Sharing Statement

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

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