Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 4 N=23 Randomized Double-blind Basic Science

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

Healthy · Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01993108 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Reaction Time Variability on the Multi-Source Interference Task — .22; .23; .26; .20 seconds — p=.02

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Methylphenidate (Drug); Naltrexone (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

Back to search