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

NCT ID: NCT01993108

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-02-28

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.

Conditions

Healthy; Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

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

Naltrexone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

One dose of placebo one hour before fMRI scanning.

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.

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

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

Naltrexone

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

One dose of placebo one hour before fMRI scanning.

Interventions

Methylphenidate

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

Intervention Type: DRUG

Naltrexone

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

Intervention Type: DRUG

Placebo

One dose of placebo one hour before fMRI scanning.

Intervention Type: DRUG

Other Intervention Names

Ritalin; ReVia; sugar pill

Eligibility Criteria

Inclusion Criteria

• Right-Handedness

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Chandra Sekhar Sripada

Assistant Professor of Psychiatry at the University of Michigan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chandra Sekhar Sripada, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Rachel Upjohn Building, East Medical Campus

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00047129

Identifier Type: -

Identifier Source: org_study_id