Combination Nicotine Replacement for Alcoholic Smokers

Yale University

Status and phase: Completed; Phase 4

Conditions: Alcoholism; Smoking

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00064844

R01AA011197 (U.S. NIH Grant/Contract)

NIAAACOO11197-05

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Nicotine patch plus placebo gum

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation

Drug: Placebo gum

Drug: Nicoderm CQ nicotine patch

Nicotine patch plus active gum

Active Comparator group

Description:

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.

Treatment:

Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation

Drug: Nicotine gum - Nicorette®

Drug: Nicoderm CQ nicotine patch