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NCT Number: NCT01993108

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rachel Upjohn Building, East Medical Campus

Ann Arbor, Michigan, 48109-2700, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

One dose 40mgs of methylphenidate one hour before fMRI scanning.

Other names: Ritalin

Naltrexone

Drug

One dose 40mgs of naltrexone one hour before fMRI scanning.

Other names: ReVia

Placebo

Drug

One dose of placebo one hour before fMRI scanning.

Other names: sugar pill

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study

Acronym: NMAS

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Nov 25, 2013
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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