Combination Nicotine Replacement for Alcoholic Smokers
Condition: Smoking; Alcoholism
MeSH terms: Alcoholism
Intervention: Cognitive Behavior Therapy for alcohol and smoking cessation; Nicoderm CQ nicotine patch; Placebo gum; Nicotine gum - Nicorette®
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking; Alcoholism

Summary:

      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.
    

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.