Phase 4
Completed N=23
Control of Cognition (Naltrexone, Methylphenidate, and ADHD Study (NMAS))
Healthy · Attention Deficit Hyperactivity Disorder
Source: ClinicalTrials.gov NCT01993108 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcomePrimary: Reaction Time Variability on the Multi-Source Interference Task — .22; .23; .26; .20 seconds — p=.02
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaction Time Variability on the Multi-Source Interference Task |
.22; .23; .26; .20; .20; .21 | .02 sig |
| SECONDARY Reaction Time on the Multi-Source Interference Task |
.78; .83; .85; .71; .73; .77 | .019 sig |
| SECONDARY Accuracy on the Multi-Source Interference Task |
96; 93; 91; 93; 93; 92 | .049 sig |
| SECONDARY Characterize the Effects of Methylphenidate and Naltrexone on Neural Circuits in Prefrontal Cortex Associated With Top-down Control. |
.21; .51; .20; .43; .58; .47 | .926 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01993108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.