| Primary | Smoking Abstinence (Point Prevalent) | 7-day point prevalent abstinence at 12 months, confirmed by exhaled CO <=10 | n=4 deceased participants were excluded from analysis. Missing values were counted as smokers. | Posted | | Count of Participants | | Participants | | Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.88 | | | | | | | | | | | | | | Superiority | Based on prior studies using precessation NRT, we estimate a 2-fold increase in cessation outcomes in the GMT group compared to the SC group. Given our recruitment of patients at all levels of readiness to quit, we estimate a 12 month cessation rate of 10%. With 199 participants, in each arm, we will have an 80% power to detect a 2-fold difference or greater with a Type I error rate of 5%. | |
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| Secondary | Sustained Abstinence | 6 month sustained abstinence as measured by self-report at 6 and 12 months and confirmed by CO at 6 and 12 months. Participants who were confirmed as non-smokers by carbon monoxide (CO) at both Month 6 and Month 12 were considered to have "6-month sustained abstinence." | n=4 deceased participants were excluded from analysis. Missing values were counted as smokers. | Posted | | Count of Participants | | Participants | | Month 6 through Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Quit Attempts | Number of self-reported quit attempts over one year. At Month 3 and Month 6, participants reported the number of quit attempts in the last 3 months. At Month 12, participants reported the number of quit attempts in the last 6 months. | n=4 deceased participants were excluded from analysis. | Posted | | Mean | Standard Deviation | number of quit attempts | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Average Cigarettes Per Day | Average number of cigarettes per day over one year. Participants were asked at Month 3, Month 6, and Month 12 "During the past 7 days, on those days that you smoked, what was the average number of cigarettes or little cigars smoked per day?" | n=4 deceased participants excluded from analysis | Posted | | Mean | Standard Deviation | cigarettes per day | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Carbon Monoxide Exposure | Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. | n=4 deceased participants excluded from analysis | Posted | | Mean | Standard Deviation | parts per million (ppm) | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Carcinogen Exposure | Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. | n=4 deceased participants were excluded from analysis. | Posted | | Geometric Mean | Standard Deviation | pg/mg creatinine | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Respiratory Function | Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization. | n=4 deceased participants excluded from analysis. Participants with missing data excluded. | Posted | | Mean | Standard Deviation | % of predicted | | Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Respiratory Symptoms | Respiratory symptoms as measured by the COPD Assessment Test (CAT) respiratory questionnaire. Participants completed this 8-item assessment at Month 3, Month 6, and Month 12. Scores range from 0 to 40, with higher levels indicating higher impact of COPD on well-being and daily life. | n=4 deceased participants excluded from analysis | Posted | | Mean | Standard Deviation | units on a scale | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Respiratory-related Hospital Visits | Number of respiratory-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for respiratory-related problems at Month 3, Month 6, and Month 12 | n=4 deceased participants excluded from analysis | Posted | | Count of Participants | | Participants | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Cardiac-related Hospital Visits | Number of cardiac-related hospital admissions and emergency room visits. Participants were asked how many times they had visited the ED or were admitted to the hospital for cardiac-related problems at Month 3, Month 6, and Month 12. | n=4 deceased participants excluded from analysis | Posted | | Count of Participants | | Participants | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | 7-day Abstinence | Self-reported and biochemically verified 7-day abstinence. Participants were asked at Month 3, Month 6, and Month 12, "Have you smoked any cigarettes or little cigars, even a puff, in the past 7 days?" They also completed an exhaled carbon monoxide lab test at Month 3, 6 and 12. Biochemical verification= exhaled CO <=10 ppm. Month 12 biochemically verified abstinence is the primary outcome, and is not reported in this table. | n=4 deceased participants were excluded from analysis. Missing responses were coded as smokers. | Posted | | Count of Participants | | Participants | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Cotinine | Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. | n=4 deceased participants were excluded from analysis | Posted | | Geometric Mean | Standard Deviation | ng/mg creatinine | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Average Cigarettes Per Day (Continued Smokers Only) | Average number of cigarettes per day over one year, among continued smokers. All participants were asked "During the past 7 days, on those days that you smoked, what was the average number of cigarettes smoked per day?" at Month 3, Month 6, and Month 12. This analysis looks at the number of cigarettes per day among participants who were still smoking. | n=4 deceased participants excluded from analysis, non-smokers at each time point excluded | Posted | | Mean | Standard Deviation | cigarettes per day | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Carbon Monoxide Exposure (Continued Smokers Only) | Carbon monoxide (CO) exposure over 12 months. At Month 3, Month 6, and Month 12, participants completed an expired carbon monoxide laboratory test, which measured CO in parts per million. This analysis looks at CO among those continuing to smoke. | n=4 deceased participants excluded from analysis, non-smokers at each time point excluded | Posted | | Mean | Standard Deviation | parts per million (ppm) | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Carcinogen Exposure (Continued Smokers Only) | Creatinine-adjusted NNAL (4-(methylnitrosamino)-1-(3)pyridyl-1-butanol)) exposure over 12 months. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and NNAL. This analysis looks at NNAL among continuing smokers only. | n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded | Posted | | Geometric Mean | Standard Deviation | pg/mg creatinine | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. |
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| Secondary | Cotinine (Continued Smokers Only) | Cotinine over 12 months, adjusted for creatinine. At Month 3, Month 6, and Month 12, participants provided a urine sample that was used to assess their level of urinary creatinine and cotinine. This analysis looks at NNAL among continuing smokers only. | n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded | Posted | | Geometric Mean | Standard Deviation | ng/mg creatinine | | Month 3, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Standard Smoking Cessation | Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Standard Smoking Cessation: Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt. Nicotine replacement therapy | | OG001 | Extended Nicotine Replacement Therapy | Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. Extended Nicotine Replacement Therapy: Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting. Nicotine replacement therapy |
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