Combination Nicotine Replacement for Alcoholic Smokers

August 11, 2021 updated by: Yale University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Newington, Connecticut, United States, 06111
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Nicotine patch plus 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.
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.
Active Comparator: Nicotine patch plus active 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. 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.
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Month Smoking Abstinence
Time Frame: 6 months after smoking quit date
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
6 months after smoking quit date
12 Month Smoking Abstinence
Time Frame: 12 months after smoking quit date
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
12 months after smoking quit date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Ned Cooney, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

July 14, 2003

First Submitted That Met QC Criteria

July 14, 2003

First Posted (Estimate)

July 15, 2003

Study Record Updates

Last Update Posted (Actual)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAACOO11197-05
  • R01AA011197 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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