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Trial record 27 of 239 for:    (armodafinil)

Modafinil for the Treatment of Alcohol Use Disorders

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ClinicalTrials.gov Identifier: NCT03424681
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Claire Wilcox, The Mind Research Network

Brief Summary:
Alcohol use disorder (AUD) is a major cause of morbidity and mortality and more treatments are needed, especially pharmacotherapies. There are a variety of efficacious treatments for AUD, but effect sizes are small, and vary from study to study. Medications may be more effective if particular subgroups of AUD are targeted. Identifying the mechanisms of action of a particular medication will help identify the subtypes more likely to respond to therapy. Global impulse control is a rational treatment target, and improving it is a likely mechanisms by which some medications for AUD work, especially in subtypes of AUD with impaired impulse control at baseline. Modafinil is a medication that is FDA approved for the treatment of narcolepsy, and is relatively safe and tolerable. There is reason to believe it may improve impulse control, and underlying neural circuitry, and may work best to improve alcohol use outcomes in AUD with poor impulse control. The overall aim of this study is to investigate the effects of modafinil on task performance and the integrity of neural circuits mediating response inhibition in treatment-seeking AUD with poor response inhibition, to establish target engagement. Secondary aims are to measure whether target engagement mediates improvement in alcohol use outcomes, and to utilize machine learning to identify neural and behavioral markers which best predict treatment outcomes. Twenty-four individuals with AUD and impaired response inhibition will be enrolled in the study, randomized to modafinil or placebo, and treated for 6 weeks. Functional magnetic resonance imaging brain scans during a response inhibition task and during rest will be obtained at baseline and 2 weeks. Aversive stimuli will be included in the response inhibition task to assure that efficacy generalizes to several conditions. Diffusion imaging and arterial spin labeling sequences will also be obtained. Investigators predict that modafinil will significantly increase brain activity in the medial and lateral prefrontal cortex during response inhibition, thereby establishing target engagement, and that it will improve alcohol use outcomes. Findings will provide information about whether or not a larger R01 trial investigating the efficacy of modafinil for individuals with AUD and impaired response inhibition is warranted.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Modafinil Other: Placebo Phase 2

Detailed Description:
see above.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modafinil for the Treatment of Alcohol Use Disorders: Targeting Impaired Response Inhibition
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: Modafinil
Modafinil 300 mg by mouth each day
Drug: Modafinil
Modafinil 300 mg by mouth daily
Other Name: Provigil

Placebo Comparator: Placebo
Identical looking capsule/number of capsules by mouth each day without active medication
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Time to relapse [ Time Frame: over 10 weeks ]
    Time to relapse


Secondary Outcome Measures :
  1. drinks per drinking day [ Time Frame: Weeks 4-6 ]
    drinks per drinking day

  2. drinks per week [ Time Frame: Weeks 4-6 ]
    drinks per week

  3. percent days abstinent [ Time Frame: Weeks 4-6 ]
    percent days abstinent



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females age 18-65 meeting Diagnostic and Statistical Manual V criteria for moderate or severe AUD in the past year
  • Interested in cutting down or quitting
  • Able to provide voluntary informed consent
  • Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and 4 for women) in the past 60 days
  • Stop signal reaction time on a stop signal task>233

Exclusion Criteria:

  • Severe neurological conditions (severe traumatic brain injury/stroke/active seizure disorder)
  • Heart disease [mitral valve prolapse, left ventricular hypertrophy, cardiac arrhythmias, angina, myocardial infarction, unstable angina, cardiac syncope or pre-syncope, any electrocardiogram (ECG) finding that suggests the presence of one of these conditions]
  • Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100)
  • Heart rate greater than 70% of the maximum expected for age [0.70(220-age)]
  • Chronic renal or hepatic failure
  • Recent pancreatitis
  • Insulin-dependent diabetes
  • Other urgent medical problems
  • Elevated liver function tests (AST or ALT greater than 4 times normal; modafinil is metabolized primarily by the liver)
  • Schizophrenia, schizoaffective disorder, Bipolar I disorder, suicidal thoughts in the last month
  • Current moderate or severe other substance use disorder (SUD) (except nicotine or marijuana)
  • Active legal problems with the potential to result in incarceration
  • Pregnancy or lactation, or child bearing age and not on birth control
  • Current daily use of anti-craving medications, stimulants, benzodiazepines, opiates, anti-psychotics; current daily use of tricyclic antidepressants, bupropion, monoamine oxidase inhibitors, serotonin and norepinephrine reuptake inhibitors, or therapeutic doses (for bipolar disorder) of mood stabilizers
  • Taking a medication contraindicated for use with modafinil

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424681


Contacts
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Contact: Claire Wilcox, MD 505-633-8102 cwilcox@mrn.org

Locations
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United States, New Mexico
Mind Research Network Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Claire Wilcox, MD    505-633-8102      
Sponsors and Collaborators
The Mind Research Network
Investigators
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Principal Investigator: Claire Wilcox, MD Mind Research Network

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Responsible Party: Claire Wilcox, Associate Professor, The Mind Research Network
ClinicalTrials.gov Identifier: NCT03424681     History of Changes
Other Study ID Numbers: FP00002746
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Modafinil
Disease
Alcohol Drinking
Alcoholism
Pathologic Processes
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action