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Table 1 Inclusion and Exclusion Criteria

From: Pharmacokinetics, safety, and tolerability of a depot formulation of naltrexone in alcoholics: an open-label trial

Inclusion Criteria

   • 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