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

NCT01993108 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00047129
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Attention Deficit Hyperactivity Disorder

Keywords

Methylphenidate; Naltrexone; Placebo; Neuroimaging; Prefrontal Control Circuits; Attention Control; Motor Control; Appetitive Control

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Secondary Outcomes (3)

• Reaction Time on the Multi-Source Interference Task

  Two hours

• Accuracy on the Multi-Source Interference Task

  Two hours

• Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.

  Two hours

Study Arms (2)

Healthy Controls

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Naltrexone; Drug: Placebo

Adult Attention-Deficit/Hyperactivity Disorder

EXPERIMENTAL

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.

Drug: Methylphenidate; Drug: Naltrexone; Drug: Placebo

Interventions

Methylphenidate DRUG

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

Also known as: Ritalin

Adult Attention-Deficit/Hyperactivity Disorder; Healthy Controls

Naltrexone DRUG

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

Also known as: ReVia

Adult Attention-Deficit/Hyperactivity Disorder; Healthy Controls

Placebo DRUG

One dose of placebo one hour before fMRI scanning.

Also known as: sugar pill

Adult Attention-Deficit/Hyperactivity Disorder; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-Handedness

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Rachel Upjohn Building, East Medical Campus

Ann Arbor, Michigan, 48109-2700, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Naltrexone; Sugars

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Chandra Sripada
• Organization: University of Michigan

sripada@umich.edu

734 232 0281

Study Officials

• Chandra Sekhar Sripada, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry at the University of Michigan

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2017
• Last Updated: June 18, 2018
• Results First Posted: June 18, 2018

Record last verified: 2018-05

Locations

US (1)