Combination Nicotine Replacement for Alcoholic Smokers

Phase 4

Completed

Conditions: Smoking
Alcoholism

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

Registration Number: NCT00064844

Lead Sponsor: Yale University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 96

Inclusion Criteria

Not provided

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine patch plus placebo gum	Cognitive Behavior Therapy for alcohol and smoking cessation	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 patch plus placebo gum	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. 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 patch plus placebo gum	Placebo 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.
Nicotine patch plus active gum	Cognitive Behavior Therapy for alcohol and smoking cessation	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.
Nicotine patch plus active gum	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. 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.
Nicotine patch plus active gum	Nicotine gum - Nicorette®	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.

Primary Outcome Measures

Name	Time	Method
12 Month Smoking Abstinence	12 months after smoking quit date	Percentage of participants with prolonged carbon monoxide verified smoking abstinence
6 Month Smoking Abstinence	6 months after smoking quit date	Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Secondary Outcome Measures