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Healthy | Control of Cognition

Healthy research study

What is the primary objective of 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 stimulant 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. Thus, using the fMRI technique, our main purpose for this research is to better understand the functioning of regulatory circuits in conditions such as ADHD and alcohol dependence. This research may one day help us develop better treatments for these disorders.

Who is eligible to participate?

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 Inclusion Criteria for the participants with a history of alcohol dependence: - Currently un-medicated adults with a history of alcohol dependence - Has met full DSM-IV-R criteria - Endorses a moderate or severe level of impairment attributed to the alcohol dependence symptoms - Has a history of alcohol dependence but not currently symptomatic (past 2 years) Inclusion Criteria for participants with both ADHD and history of alcohol dependence: - Currently un-medicated adults with ADHD and a history of alcohol dependence - 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 met full DSM-IV-R criteria (history of alcohol dependence) - 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 - Endorses a moderate or severe level of impairment attributed to the alcohol dependence symptoms - Has a history of alcohol dependence but not currently symptomatic (past 2 years)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Attention Deficit Hyperactivity Disorder

Alcohol Dependence

Attention Deficit Hyperactivity Disorder and Alcohol Dependence

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MethylphenidateAll study participants will receive one dose of any three of the following drug compounds 1 hour before fMRI scan and task performance: 40mgs of methylphenidate, 40mgs of naltrexone, or a placebo. There are a total of three scans per participant, therefore all participants will receive one dose of all three drug compounds for any given scan during their participation in the study.

Drug:NaltrexoneAll study participants will receive one dose of any three of the following drug compounds 1 hour before fMRI scan and task performance: 40mgs of methylphenidate, 40mgs of naltrexone, or a placebo. There are a total of three scans per participant, therefore all participants will receive one dose of all three drug compounds for any given scan during their participation in the study

Drug:PlaceboAll study participants will receive one dose of any three of the following drug compounds 1 hour before fMRI scan and task performance: 40mgs of methylphenidate, 40mgs of naltrexone, or a placebo. There are a total of three scans per participant, therefore all participants will receive one dose of all three drug compounds for any given scan during their participation in the study

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MethylphenidateThe total recruitment aim of 160 adult participants for this study will be divided into 4 subject group-types: [1]40 Healthy adults [2]40 adults with Attention Deficit Hyperactivity Disorder (ADHD) [3]40 adults with a history of Alcohol Dependence [4]40 adults with combined ADHD and history of Alcohol Dependence. Every participant in all four groups will be administered a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session and task performance. No participants will be administered any of the three drug compounds more than once during the study. The order for which medication type is given at which scanning session for every participant is determined by randomization code.

NaltrexoneThe total recruitment aim of 160 adult participants for this study will be divided into 4 subject group-types: [1]40 Healthy adults [2]40 adults with Attention Deficit Hyperactivity Disorder (ADHD) [3]40 adults with a history of Alcohol Dependence [4]40 adults with combined ADHD and history of Alcohol Dependence. Every participant in all four groups will be administered a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session and task performance. No participants will be administered any of the three drug compounds more than once during the study. The order for which medication type is given at which scanning session for every participant is determined by randomization code.

Sugar PillThe total recruitment aim of 160 adult participants for this study will be divided into 4 subject group-types: [1]40 Healthy adults [2]40 adults with Attention Deficit Hyperactivity Disorder (ADHD) [3]40 adults with a history of Alcohol Dependence [4]40 adults with combined ADHD and history of Alcohol Dependence. Every participant in all four groups will be administered a one-time, randomized dose of 40mgs of Methylphenidate, 40mgs of Naltrexone, and a placebo one hour before the fMRI scanning session and task performance. No participants will be administered any of the three drug compounds more than once during the study. The order for which medication type is given at which scanning session for every participant is determined by randomization code.

Study Status

Active, not recruiting

Start Date: October 2013

Completed Date: May 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Identify abnormalities in prefrontal control neural circuits underlying attention control, motor control, and appetitive control

Secondary Outcome: Reaction time on the Multi-Source Interference Task

Study sponsors, principal investigator, and references

Principal Investigator: Chandra Sekhar Sripada, MD, PhD

Lead Sponsor: University of Michigan

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01993108

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