HealthyPhase 4NMASNCT01993108
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
A Phase 4 study testing Methylphenidate and Naltrexone in people with Healthy and Attention Deficit Hyperactivity Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate and Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rachel Upjohn Building, East Medical Campus
Ann Arbor, Michigan, 48109-2700
About this study
Official title: Control of Cognition: Naltrexone, Methylphenidate, and ADHD 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.
Read the 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
- Being tested
- Methylphenidate, Naltrexone, Placebo
- Keywords
- Methylphenidate, Naltrexone, Placebo, Neuroimaging, Prefrontal Control Circuits, Attention Control, Motor Control, Appetitive Control
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
One dose 40mgs of methylphenidate one hour before fMRI scanning.
NaltrexoneDrug
Also called ReVia
One dose 40mgs of naltrexone one hour before fMRI scanning.
PlaceboDrug
Also called sugar pill
One dose of placebo one hour before fMRI scanning.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Methylphenidate; Drug: Naltrexone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Secondary outcomes (3)
Reaction Time on the Multi-Source Interference Task
Reaction time of the Multi-Source Interference Task is measured in seconds.
Measured: 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.
Measured: 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.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandra Sekhar Sripada, University of Michigan
- Investigators
- Chandra Sekhar Sripada, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993108
- Sponsor's protocol ID
- HUM00047129
- Acronym
- NMAS
- Status last verified
- May 2018
- First submitted
- 13 Nov 2013
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Cognition: Naltrexone, Methylphenidate, and ADHD Study
- ClinicalTrials.gov ID
- NCT01993108
- Acronym / sponsor ID
- NMAS / HUM00047129
- Conditions
- Healthy, Attention Deficit Hyperactivity Disorder
- Keywords
- Methylphenidate, Naltrexone, Placebo, Neuroimaging, Prefrontal Control Circuits, Attention Control, Motor Control, Appetitive Control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 18 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Drug: Methylphenidate, Drug: Naltrexone, Drug: PlaceboHealthy 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 | Drug: Methylphenidate, Drug: Naltrexone, Drug: PlaceboADHD 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: RitalinOne dose 40mgs of methylphenidate one hour before fMRI scanning. | Drug | Adult Attention-Deficit/Hyperactivity Disorder, Healthy Controls |
| NaltrexoneAlso: ReViaOne dose 40mgs of naltrexone one hour before fMRI scanning. | Drug | Adult Attention-Deficit/Hyperactivity Disorder, Healthy Controls |
| PlaceboAlso: sugar pillOne dose of placebo one hour before fMRI scanning. | Drug | Adult Attention-Deficit/Hyperactivity Disorder, Healthy Controls |
Primary outcome
Reaction Time Variability on the Multi-Source Interference Task
Time frame: 2 hours
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.
3 secondary outcomes
Reaction Time on the Multi-Source Interference Task
Time frame: Two hours
Accuracy on the Multi-Source Interference Task
Time frame: Two hours
Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control.
Time frame: Two hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandra Sekhar Sripada, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate and Naltrexone in people with Healthy and Attention Deficit Hyperactivity Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time Variability on the Multi-Source Interference Task (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.