NCT00064844

Combination Nicotine Replacement for Alcoholic Smokers

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking
• Alcoholism

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy for alcohol and smoking cessation	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.
DRUG	Nicoderm CQ nicotine patch	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.
DRUG	Placebo gum	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.
DRUG	Nicotine gum - Nicorette®	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.

Timeline

• Start date: 2002-08-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2003-07-15
• Last updated: 2021-08-13
• Results posted: 2013-04-16

Locations

1 site across 1 country: United States