Combination Nicotine Replacement for Alcoholic Smokers

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavior Therapy for alcohol and smoking cessation

Nicoderm CQ nicotine patch

Placebo gum

Nicotine gum - Nicorette®

About this trial

This is an interventional treatment trial for Smoking focused on measuring Smoking, Alcoholism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Nicotine patch plus placebo gum

Nicotine patch plus active gum

Arm 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.

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.

Outcomes

Primary Outcome Measures

6 Month Smoking Abstinence

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

12 Month Smoking Abstinence

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Secondary Outcome Measures

Full Information

NCT ID

NCT00064844

First Posted

July 14, 2003

Last Updated

August 11, 2021

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00064844

Brief Title

Combination Nicotine Replacement for Alcoholic Smokers

Official Title

Combination Nicotine Replacement for Alcoholic Smokers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 2002 (undefined)

Primary Completion Date

July 2006 (Actual)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking, Alcoholism

Keywords

Smoking, Alcoholism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nicotine patch plus placebo gum

Arm Type

Placebo Comparator

Arm 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.

Arm Title

Nicotine patch plus active gum

Arm Type

Active Comparator

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavior Therapy for alcohol and smoking cessation

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nicoderm CQ nicotine patch

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Placebo gum

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Nicotine gum - Nicorette®

Intervention Description

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 Measure Information:

Title

6 Month Smoking Abstinence

Description

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Time Frame

6 months after smoking quit date

Title

12 Month Smoking Abstinence

Description

Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Time Frame

12 months after smoking quit date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ned Cooney, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Connecticut Healthcare System

City

Newington

State/Province

Connecticut

ZIP/Postal Code

06111

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

19549054

Citation

Cooney NL, Cooney JL, Perry BL, Carbone M, Cohen EH, Steinberg HR, Pilkey DT, Sevarino K, Oncken CA, Litt MD. Smoking cessation during alcohol treatment: a randomized trial of combination nicotine patch plus nicotine gum. Addiction. 2009 Sep;104(9):1588-96. doi: 10.1111/j.1360-0443.2009.02624.x. Epub 2009 Jun 22.

Results Reference

background

PubMed Identifier

22023022

Citation

Holt LJ, Litt MD, Cooney NL. Prospective analysis of early lapse to drinking and smoking among individuals in concurrent alcohol and tobacco treatment. Psychol Addict Behav. 2012 Sep;26(3):561-72. doi: 10.1037/a0026039. Epub 2011 Oct 24.

Results Reference

background

Smoking, Alcoholism

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial