Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Nalmefene in Nicotine and Alcohol Dependence

Conditions
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Smoking, Alcoholism

Intervention / Treatment
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* Drug: Naltrexone Tablet and Nicotine Patch
* Drug: Naltrexone Tablet and Placebo Patch
* Drug: Placebo Tablet and Nicotine Patch
* Drug: Placebo Tablet and Placebo Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets criteria for alcohol dependence and nicotine dependence. Expresses a desire to cut down or stop drinking and smoking. Exclusion Criteria: Currently meets criteria for dependence on substances other than alcohol and nicotine. Any history of opiate dependence or evidence of current opiate use. Significant medical disorders that will increase potential risk or interfere with study participation. 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 form. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naltrexone Tablet and Nicotine Patch<br> | Drug: Naltrexone Tablet and Nicotine Patch<br> <br> * Other names: Revia and Nicotrol;|
| Active Comparator: Naltrexone Tablet and Placebo Patch<br> | Drug: Naltrexone Tablet and Placebo Patch<br> <br> * Other names: Revia;|
| Active Comparator: Placebo Tablet and Nicotine Patch<br> | Drug: Placebo Tablet and Nicotine Patch<br> <br> * Other names: Nicotrol;|
| Placebo Comparator: Placebo Tablet and Placebo Patch<br> | Drug: Placebo Tablet and Placebo Patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |