Combination Nicotine Replacement for Alcoholic Smokers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Smoking Alcoholism	Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Combination Nicotine Replacement for Alcoholic Smokers

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

6 Month Smoking Abstinence [ Time Frame: 6 months after smoking quit date ] [ Designated as safety issue: No ]
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
12 Month Smoking Abstinence [ Time Frame: 12 months after smoking quit date ] [ Designated as safety issue: No ]
Percentage of participants with prolonged carbon monoxide verified smoking abstinence

Enrollment:	96
Study Start Date:	August 2002
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.

Arms

Assigned Interventions

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064844

Locations

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

Sponsors and Collaborators

Yale University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Ned Cooney, PhD

Yale University

More Information

Publications:

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. Epub 2009 Jun 22.

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.

Responsible Party:	Ned Cooney, Associate Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00064844 History of Changes
Other Study ID Numbers:	NIAAACOO11197-05, R01AA011197
Study First Received:	July 14, 2003
Results First Received:	January 31, 2013
Last Updated:	March 8, 2013
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Smoking
Alcoholism

Additional relevant MeSH terms:

Alcoholism
Smoking
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013