SmokingPhase 4NCT00064844
Combination Nicotine Replacement for Alcoholic Smokers
A Phase 4 study testing Cognitive Behavior Therapy for alcohol and smoking cessation, Nicoderm CQ nicotine patch and Nicotine gum - Nicorette® in people with Smoking and Alcoholism, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Alcoholism
- What is being tested?
- Cognitive Behavior Therapy for alcohol and smoking cessation, Nicoderm CQ nicotine patch and Nicotine gum - Nicorette®
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Jul 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
Newington, Connecticut, 06111
About this study
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.
- Conditions
- Smoking, Alcoholism
- Being tested
- Cognitive Behavior Therapy for alcohol and smoking cessation, Nicoderm CQ nicotine patch, Placebo gum, Nicotine gum - Nicorette®
- Keywords
- Smoking, Alcoholism
- Medical subject headings
- Smoking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for alcohol and smoking cessationBehavioural
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.
Nicoderm CQ nicotine patchDrug
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 gumDrug
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 - Nicorette®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine patch plus placebo gum | Placebo comparator | 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. Receives: Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation; Drug: Nicoderm CQ nicotine patch; Drug: Placebo gum |
| Nicotine patch plus active gum | Active comparator | 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. Receives: Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation; Drug: Nicoderm CQ nicotine patch; Drug: Nicotine gum - Nicorette® |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Measured: 6 months after smoking quit date
12 Month Smoking Abstinence
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Measured: 12 months after smoking quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2003 (estimated)
- Study startAug 2002
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Ned Cooney, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064844
- Sponsor's protocol ID
- NIAAACOO11197-05
- Other IDs
- R01AA011197
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2003
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1111/j.1360-0443.2009.02624.x. Epub 2009 Jun 22.
PubMed 19549054Holt 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.
PubMed 22023022
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Nicotine Replacement for Alcoholic Smokers
- ClinicalTrials.gov ID
- NCT00064844
- Acronym / sponsor ID
- NIAAACOO11197-05
- Conditions
- Smoking, Alcoholism
- Keywords
- Smoking, Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 15 Jul 2003 (estimated)
- Results
- Posted 16 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotine patch plus placebo gum | Placebo comparator | Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation, Drug: Nicoderm CQ nicotine patch, Drug: Placebo gumSubjects 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 comparator | Behavioral: Cognitive Behavior Therapy for alcohol and smoking cessation, Drug: Nicoderm CQ nicotine patch, Drug: Nicotine gum - Nicorette®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy for alcohol and smoking cessationIndividual 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. | Behavioural | Nicotine patch plus active gum, Nicotine patch plus placebo gum |
| Nicoderm CQ nicotine patchSubjects 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 patch plus active gum, Nicotine patch plus placebo gum |
| Placebo gumPlacebo 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. | Drug | Nicotine patch plus placebo gum |
| 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. | Drug | Nicotine patch plus active gum |
Primary outcome
6 Month Smoking Abstinence
Time frame: 6 months after smoking quit date
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
12 Month Smoking Abstinence
Time frame: 12 months after smoking quit date
Percentage of participants with prolonged carbon monoxide verified smoking abstinence
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19549054Cooney 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.
- Background: PubMed 22023022Holt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ned Cooney, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cognitive Behavior Therapy for alcohol and smoking cessation, Nicoderm CQ nicotine patch and Nicotine gum - Nicorette® in people with Smoking and Alcoholism, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Month Smoking Abstinence (time frame: 6 months after smoking quit date). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00064844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.