Inclusion Criteria |
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   • Males or non-pregnant, non-nursing females, age 18 to 65, with a DSM-IV diagnosis of alcohol dependence who express a desire to stop drinking. |
   • Heavy drinking (5 drinks/day for males or 4 drinks/day for females) within 14 days prior to randomization |
   • Able to achieve at least three continuous days of sobriety, without detoxification medications, immediately before beginning the oral naltrexone run-in dosing |
   • Willing and able to give informed consent |
   • Willing to practice effective birth control for duration of trial (female patients only) |
   • Available to participate in the study for 7 weeks |
   • Willing to provide names and permission to contact someone (e.g., spouse, parent, friend) who would likely know their whereabouts for follow-up tracking |
   • Naltrexone tolerance as demonstrated during run-in dosing period. |
Exclusion Criteria |
   • Currently taking disulfiram (Antabuse), naltrexone (Revia or generic) or neuroleptic medication |
   • In need of medical detoxification from alcohol |
   • DSM-IV diagnosis of dependence on any drug of abuse other than nicotine or alcohol or drug screen showing benzodiazepines, marijuana, cocaine, methamphetamine, barbituates or heroin |
   • Clinical evidence of cardiac ischemia (by EKG or medical history) or history of myocardial infarction within the previous 2 years |
   • History of pancreatitis |
   • Planned surgery within 7 weeks of screening |
   • Any chronic or episodic painful conditions that would reasonably require opiate medications for pain control |
   • ALT or AST elevations more than 3 times the upper limit of normal |
   • Subjects with any psychiatric (e.g., depression with suicidal ideation) or medical condition that would preclude safe participation in the protocol. |
   • History of allergic or adverse response to naltrexone |
   • Participation in a trial of an investigational medication within 30 days prior to study enrollment |
   •Subjects mandated by court for alcohol or drug abuse treatment or having pending legal proceedings that could result in incarceration within 7 weeks of screening |