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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA011197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavior Therapy for alcohol and smoking cessation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ned Cooney, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | Newington | Connecticut | 06111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19549054 | Background | 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. | |
| 22023022 | Background | 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. |
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96 men and women were randomized to treatment at the Newington and West Haven campuses of the Veterans Affairs (VA) Connecticut Healthcare System.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Patch Plus Active Gum | |
| FG001 | Nicotine Patch Plus Placebo Gum |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Patch Plus Active Gum | |
| BG001 | Nicotine Patch Plus Placebo Gum | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6 Month Smoking Abstinence | Percentage of participants with prolonged carbon monoxide verified smoking abstinence | Posted | Number | percentage of participants abstinent | 6 months after smoking quit date |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nicotine Patch Plus Active Gum |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bleeding gums | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ned Cooney, PhD | Yale University School of Medicine | 860-594-6339 | ned.cooney@yale.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D000431 | Ethanol |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D000438 | Alcohols |
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|
| Nicoderm CQ nicotine patch | Drug | 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 | Drug | 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. |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 12 Month Smoking Abstinence | Percentage of participants with prolonged carbon monoxide verified smoking abstinence | Posted | Number | percentage of participants abstinent | 12 months after smoking quit date |
|
|
|
|
| 0 |
| 45 |
| 1 |
| 45 |
| EG001 | Nicotine Patch Plus Placebo Gum | 0 | 51 | 7 | 51 |
| jaw ache | General disorders | Non-systematic Assessment |
|
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| D001523 | Mental Disorders |
| D009930 |
| Organic Chemicals |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D061485 | Tobacco Use Cessation Devices |
| D013812 | Therapeutics |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |