Early problem drinkers are prevalent in the United States. Recent controlled trials have
shown that brief interventions in the primary care setting can reduce drinking and
alcohol-related problems in patients who lack evidence of alcohol dependence.
Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few
pharmacotherapy studies have been undertaken with early problem drinkers. This study is an
8-week trial of naltrexone versus placebo, combined with coping skills treatment that either
focuses on targeted use of medication or serves as background to daily use of the
medication. A total of 160 early problem drinkers recruited through screening in primary
care medical settings will be randomly assigned to one of four treatment groups. Followup
evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.
- Limited to early problem drinkers (i.e., those with no more than mild alcohol
- Have an average weekly alcohol consumption of greater than or equal to 24 standard
drinks for men and 18 standard drinks for women.
- Able to read English at the eighth grade or higher level and show no evidence of
significant cognitive impairment.
- Willing to provide a collateral informant for interviews regarding the patient's
drinking during the study.
- A woman of child-bearing potential must be non-lactating, practicing a reliable
method of birth control, and have a negative pregnancy test prior to initiation of
- Willing to provide a signed informed consent to participate in the study.
- Have a current clinically significant physical disease or abnormality.
- Have a serious psychiatric illness.
- Have a current diagnosis of drug dependence (other than nicotine dependence) or a
lifetime diagnosis of opioid dependence.
- A current diagnosis of alcohol dependence that is moderate or greater in severity or
a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol
- Used opioids or other psychoactive medications regularly in the month prior to study
- History of hypersensitivity to naltrexone (Revia).