Combination Nicotine Replacement for Alcoholic Smokers

Study Overview
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Brief Summary
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The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be divided into two groups. One group will receive an active nicotine patch and active nicotine gum. The other group will receive an active nicotine patch and placebo nicotine gum. Followup assessments will be conducted for 1-year from the beginning of treatment.

Official Title
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Combination Nicotine Replacement for Alcoholic Smokers

Conditions
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Smoking, Alcoholism

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation
* Drug: Nicoderm CQ nicotine patch
* Drug: Placebo gum
* Drug: Nicotine gum - Nicorette®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Males and females at least 18 years old. English speaking. Meets criteria for alcohol dependence or alcohol abuse. Must complete an alcohol detoxification program prior to entering the study. Currently smoking 15 or more cigarettes per day and have at least a 3 year history of smoking. Have a current desire to stop smoking and stop drinking. Willing to complete followup assessments up to 12 months after treatment. Willing to provide names of 2 people who can help locate the subject at followup and the name of one person who can verify information about alcohol and tobacco use. One person per household. Exclusion Criteria: Allergy to nicotine patch or nicotine gum. Weigh less than 100 pounds. Use other nicotine products, such as cigars, pipes or smokeless tobacco. Severe skin disorder. Active peptic ulcer. Active joint disease. Heart attack within 3 months prior to entering the study. Pregnant or breastfeeding female who are not on birth control. Currently taking medication to treat alcoholism or smoking, such as naltrexone, disulfiram or bupropion. Poor vision or hearing that would interfere with using a cell phone. Lack of transportation to the treatment site or live at least one hour from the treatment site. Homeless.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Nicotine patch plus placebo gum<br>Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks. | Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation<br>* Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.<br>Drug: Nicoderm CQ nicotine patch<br>* Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy.<br>Drug: Placebo gum<br>* Placebo gum was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. The placebo gum (manufactured by Fertin Pharma A/S, Vejle, Denmark) contained 2.6% cayenne pepper to simulate the taste of nicotine. Use of the gum was encouraged for 24 weeks.<br>|
| Active Comparator: Nicotine patch plus active gum<br>Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks. | Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation<br>* Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devoted to alcohol treatment. Components of this intervention included identifying alcohol antecedents, coping with alcohol urges, managing thoughts about alcohol, problem solving, drink refusal skills, planning for emergencies, communication and assertiveness training and enhancing social support networks for alcohol abstinence. The smoking cessation intervention was delivered in the same sessions as the alcohol treatment, with approximately 15-20 minutes of each session devoted to smoking cessation. Treatment employed behavioral elements that have been supported empirically according to the USDHHS smoking cessation practice guideline.<br>Drug: Nicoderm CQ nicotine patch<br>* Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy.<br>Drug: Nicotine gum - Nicorette®<br>* Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day. Use of the gum was encouraged for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Month Smoking Abstinence | Percentage of participants with prolonged carbon monoxide verified smoking abstinence | 6 months after smoking quit date | 
| 12 Month Smoking Abstinence | Percentage of participants with prolonged carbon monoxide verified smoking abstinence | 12 months after smoking quit date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Alcoholism