Status:
COMPLETED
Modafinil for the Treatment of Alcohol Use Disorders
Lead Sponsor:
The Mind Research Network
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 s...
Detailed Description
see above.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03424681
Start Date
December 11 2017
End Date
August 31 2018
Last Update
May 26 2020
Active Locations (1)
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1
Mind Research Network
Albuquerque, New Mexico, United States, 87106