Combination Nicotine Replacement for Alcoholic Smokers
Smoking, Alcoholism
About this trial
This is an interventional treatment trial for Smoking focused on measuring Smoking, Alcoholism
Eligibility Criteria
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.
Sites / Locations
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Nicotine patch plus placebo gum
Nicotine patch plus active gum
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.
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.