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Miami, Florida 33136


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00000437


Primary Contact:

Principal Investigator
Barbara Mason, PhD
University of Miam


Backup Contact:

N/A


Location Contact:

Miami, Florida 33136
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 19, 2017

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