Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)

The Scripps Research Institute60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alcoholism Smoking

Interventions

Naltrexone Tablet and Nicotine PatchDRUG

Naltrexone Tablet and Placebo PatchDRUG

Placebo Tablet and Nicotine PatchDRUG

Placebo Tablet and Placebo Patch

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Psychiatry, University of Miami School of Medicine

Miami, Florida, United States

Data from ClinicalTrials.gov

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