Combination Nicotine Replacement for Alcoholic Smokers
2 other identifiers
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2002
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
July 14, 2003
CompletedFirst Posted
Study publicly available on registry
July 15, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedResults Posted
Study results publicly available
April 16, 2013
CompletedAugust 13, 2021
August 1, 2021
3.9 years
July 14, 2003
January 31, 2013
August 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
6 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
6 months after smoking quit date
12 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
12 months after smoking quit date
Study Arms (2)
Nicotine patch plus placebo gum
PLACEBO COMPARATORSubjects 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
ACTIVE COMPARATORSubjects 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.
Interventions
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.
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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare System
Newington, Connecticut, 06111, United States
Related Publications (2)
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.
PMID: 19549054BACKGROUNDHolt 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.
PMID: 22023022BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ned Cooney, PhD
- Organization
- Yale University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Ned Cooney, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2003
First Posted
July 15, 2003
Study Start
August 1, 2002
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
August 13, 2021
Results First Posted
April 16, 2013
Record last verified: 2021-08