At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Meets criteria for alcohol dependence or alcohol abuse
- ✓Must have completed an alcohol detoxification program prior to study entry
- ✓Currently smoking ≥15 cigarettes per day with ≥3 year smoking history
- ✕Allergy to nicotine patch or nicotine gum
- ✕Weight <100 pounds
- ✕Use of other nicotine products (cigars, pipes, smokeless tobacco)
- ✕Severe skin disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Combination Nicotine Replacement for Alcoholic Smokers
In Brief
A Phase 4 clinical trial evaluating Cognitive Behavior Therapy for alcohol and smoking cessation, Nicoderm CQ nicotine patch, and 2 other interventions for Smoking and Alcoholism. Completed, enrolled 96 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.