The purpose of this study is to determine the effectiveness of naltrexone (Revia) or matched
placebo combined with nicotine patch (Nicotrol) or placebo patch using a 2x2 design in
reducing drinking and smoking in patients with both nicotine and alcohol dependence.
Eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of
either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will
receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews
will be conducted 3 and 6 months after treatment to determine smoking and drinking status
and persistence of any dependence symptoms.
- Meets criteria for alcohol dependence and nicotine dependence.
- Expresses a desire to cut down or stop drinking and smoking.
- Currently meets criteria for dependence on substances other than alcohol and
- Any history of opiate dependence or evidence of current opiate use.
- Significant medical disorders that will increase potential risk or interfere with
- Liver function tests more than 3 times normal or elevated bilirubin.
- Females who are pregnant, nursing, or not using a reliable method of birth control.
- Meets criteria for a major psychiatric disorder and is in need of or currently
undergoing drug therapy.
- Inability to understand and/or comply with the provisions of the protocol and consent
- Treatment with an investigational drug during the previous month.
- Chronic treatment with any narcotic-containing medications during the previous month.
- Sensitivity to drug as evidenced by adverse drug experiences especially with
narcotic- containing analgesics or opioid antagonists.
- Current treatment with disulfiram (Antabuse) or nicotine replacement therapy.
- More than 6 weeks of abstinence.