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

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. 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.

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

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

Healthy

Attention Deficit Hyperactivity Disorder

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:MethylphenidateOne dose 40mgs of methylphenidate one hour before fMRI scanning.

Drug:NaltrexoneOne dose 40mgs of naltrexone one hour before fMRI scanning.

Drug:PlaceboOne dose of placebo one hour before fMRI scanning.

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.

Healthy ControlsHealthy 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.

Adult Attention-Deficit/Hyperactivity DisorderADHD 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.

Study Status

Completed

Start Date: October 2013

Completed Date: February 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Reaction Time Variability on the Multi-Source Interference Task

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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