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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | One dose 40mgs of methylphenidate one hour before fMRI scanning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reaction Time on the Multi-Source Interference Task | Reaction time of the Multi-Source Interference Task is measured in seconds. | Two hours |
| Accuracy on the Multi-Source Interference Task | Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task. |
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Inclusion Criteria for all study participants:
Exclusion Criteria for all study participants:
Inclusion Criteria for the participants with ADHD:
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| Name | Affiliation | Role |
|---|---|---|
| Chandra Sekhar Sripada, MD, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rachel Upjohn Building, East Medical Campus | Ann Arbor | Michigan | 48109-2700 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning. Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning. Placebo: One dose of placebo one hour before fMRI scanning. |
| FG001 | 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. Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning. Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning. Placebo: One dose of placebo one hour before fMRI scanning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning. Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning. Placebo: One dose of placebo one hour before fMRI scanning. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | 2 hours |
|
Subjects were observed for 2.5 to 3 hours during the course of each of the three scanning sessions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Methlyphenidate | 40mg methylphenidate | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chandra Sripada | University of Michigan | 734 232 0281 | sripada@umich.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D009271 | Naltrexone |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Naltrexone | Drug | One dose 40mgs of naltrexone one hour before fMRI scanning. |
|
|
| Placebo | Drug | One dose of placebo one hour before fMRI scanning. |
|
|
| Two hours |
| Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control. | 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. | Two hours |
| BG001 | 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. Methylphenidate: One dose 40mgs of methylphenidate one hour before fMRI scanning. Naltrexone: One dose 40mgs of naltrexone one hour before fMRI scanning. Placebo: One dose of placebo one hour before fMRI scanning. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Placebo in Healthy Controls |
Placebo Pill in Healthy Controls |
| OG003 | Methlyphenidate in ADHD | 40mg methylphenidate in ADHD |
| OG004 | Naltrexone in ADHD | 40mg naltrexone in ADHD |
| OG005 | Placebo in ADHD | Placebo Pill in ADHD |
|
|
|
| Secondary | Reaction Time on the Multi-Source Interference Task | Reaction time of the Multi-Source Interference Task is measured in seconds. | Posted | Mean | Standard Deviation | seconds | Two hours |
|
|
|
|
| Secondary | Accuracy on the Multi-Source Interference Task | Accuracy is the calculated percentage of correct responses over total trials in the Multi-Source Interference Task. | Posted | Mean | Standard Deviation | percent of total trials | Two hours |
|
|
|
|
| Secondary | Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control. | 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. | Posted | Mean | Standard Deviation | Mean percentage of BOLD signal change | Two hours |
|
|
|
|
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Naltrexone | 40mg Naltrexone | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Placebo | Placebo | 0 | 23 | 0 | 23 | 0 | 23 |
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| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002241 | Carbohydrates |
| Mean Difference (Final Values) |
| .02 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | .081 | Median Difference (Final Values) | .06 | 2-Sided | Superiority |
| t-test, 2 sided | .247 | Median Difference (Final Values) | .04 | 2-Sided | Superiority |
| Mean Difference (Final Values) |
| .02 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | .814 | Mean Difference (Final Values) | 0 | 2-Sided | Superiority |
| t-test, 2 sided | .593 | Mean Difference (Net) | .01 | 2-Sided | Superiority |
| Mean Difference (Final Values) |
| .31 |
| 2-Sided |
| Superiority |
| t-test, 2 sided | .852 | Mean Difference (Final Values) | .04 | 2-Sided | Superiority |
| t-test, 2 sided | .552 | Median Difference (Final Values) | .11 | 2-Sided | Superiority |