Trial Outcomes & Findings for Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers (NCT NCT02148445)
NCT ID: NCT02148445
Last Updated: 2017-10-06
Results Overview
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO \<=10
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
398 participants
Primary outcome timeframe
Month 12
Results posted on
2017-10-06
Participant Flow
667 Screened for Eligibility 153 Did not meet inclusion criteria 116 Refused to participate 398 Randomized
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
198
|
200
|
|
Overall Study
COMPLETED
|
197
|
197
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
Baseline Characteristics
Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers
Baseline characteristics by cohort
| Measure |
Standard Smoking Cessation
n=198 Participants
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.
|
Extended Nicotine Replacement Therapy
n=200 Participants
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.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 8.66 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 9.88 • n=7 Participants
|
55.9 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
190 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
113 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
236 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
35 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
200 participants
n=7 Participants
|
398 participants
n=5 Participants
|
|
Number of Quit Attempts in the Past 12 Months
|
2.2 number of quit attempts
STANDARD_DEVIATION 5.09 • n=5 Participants
|
1.9 number of quit attempts
STANDARD_DEVIATION 4.29 • n=7 Participants
|
2.1 number of quit attempts
STANDARD_DEVIATION 4.70 • n=5 Participants
|
|
Cigarettes Smoked per Day
|
22.1 cigarettes per day
STANDARD_DEVIATION 11.87 • n=5 Participants
|
24.0 cigarettes per day
STANDARD_DEVIATION 12.58 • n=7 Participants
|
23.0 cigarettes per day
STANDARD_DEVIATION 12.26 • n=5 Participants
|
|
Carbon Monoxide Exposure
|
22.2 parts per million
STANDARD_DEVIATION 13.12 • n=5 Participants
|
22.7 parts per million
STANDARD_DEVIATION 14.48 • n=7 Participants
|
22.5 parts per million
STANDARD_DEVIATION 13.81 • n=5 Participants
|
|
Carcinogen Exposure (Creatinine Adjusted NNAL)
|
451.3 pg/mg
STANDARD_DEVIATION 422.74 • n=5 Participants
|
507.4 pg/mg
STANDARD_DEVIATION 764.95 • n=7 Participants
|
475.0 pg/mg
STANDARD_DEVIATION 604.41 • n=5 Participants
|
|
Number of respiratory-related hospital admissions and ED visits in the past 12 months
0 Visits
|
122 Participants
n=5 Participants
|
134 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Number of respiratory-related hospital admissions and ED visits in the past 12 months
1 Visit
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Number of respiratory-related hospital admissions and ED visits in the past 12 months
2 or more Visits
|
46 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Number of cardiac-related hospital admissions and ED visits in the past 12 months
0 Visits
|
178 Participants
n=5 Participants
|
171 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Number of cardiac-related hospital admissions and ED visits in the past 12 months
1 Visit
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Number of cardiac-related hospital admissions and ED visits in the past 12 months
2 or more Visits
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Respiratory Symptoms
|
21.1 units on a scale
STANDARD_DEVIATION 8.82 • n=5 Participants
|
22.9 units on a scale
STANDARD_DEVIATION 8.32 • n=7 Participants
|
22.0 units on a scale
STANDARD_DEVIATION 9.00 • n=5 Participants
|
|
Respiratory Function
|
57.3 % of predicted
STANDARD_DEVIATION 18.61 • n=5 Participants
|
56.7 % of predicted
STANDARD_DEVIATION 21.03 • n=7 Participants
|
57.0 % of predicted
STANDARD_DEVIATION 19.84 • n=5 Participants
|
|
Cotinine
|
2395.8 ng/mg of creatinine
STANDARD_DEVIATION 2184.80 • n=5 Participants
|
2447.2 ng/mg of creatinine
STANDARD_DEVIATION 2433.58 • n=7 Participants
|
2421.6 ng/mg of creatinine
STANDARD_DEVIATION 2310.39 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.
7-day point prevalent abstinence at 12 months, confirmed by exhaled CO \<=10
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Smoking Abstinence (Point Prevalent)
|
23 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Month 6 through Month 12Population: n=4 deceased participants were excluded from analysis. Missing values were counted as smokers.
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."
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Sustained Abstinence
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis.
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Quit Attempts
Month 3
|
4.6 number of quit attempts
Standard Deviation 6.54
|
3.7 number of quit attempts
Standard Deviation 5.48
|
|
Quit Attempts
Month 6
|
4.5 number of quit attempts
Standard Deviation 6.86
|
4.8 number of quit attempts
Standard Deviation 8.97
|
|
Quit Attempts
Month 12
|
5.7 number of quit attempts
Standard Deviation 8.59
|
6.2 number of quit attempts
Standard Deviation 11.31
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis
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?"
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Average Cigarettes Per Day
Month 3
|
7.9 cigarettes per day
Standard Deviation 8.64
|
10.5 cigarettes per day
Standard Deviation 8.64
|
|
Average Cigarettes Per Day
Month 6
|
8.1 cigarettes per day
Standard Deviation 8.52
|
9.1 cigarettes per day
Standard Deviation 9.45
|
|
Average Cigarettes Per Day
Month 12
|
8.5 cigarettes per day
Standard Deviation 7.84
|
8.1 cigarettes per day
Standard Deviation 8.33
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Carbon Monoxide Exposure
Month 3
|
15.0 parts per million (ppm)
Standard Deviation 12.62
|
17.4 parts per million (ppm)
Standard Deviation 13.69
|
|
Carbon Monoxide Exposure
Month 6
|
14.6 parts per million (ppm)
Standard Deviation 11.85
|
15.4 parts per million (ppm)
Standard Deviation 12.58
|
|
Carbon Monoxide Exposure
Month 12
|
15.5 parts per million (ppm)
Standard Deviation 11.14
|
13.8 parts per million (ppm)
Standard Deviation 11.14
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis.
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Carcinogen Exposure
Month 6
|
178.2 pg/mg creatinine
Standard Deviation 221.26
|
186.0 pg/mg creatinine
Standard Deviation 236.21
|
|
Carcinogen Exposure
Month 12
|
190.4 pg/mg creatinine
Standard Deviation 233.22
|
183.5 pg/mg creatinine
Standard Deviation 223.94
|
|
Carcinogen Exposure
Month 3
|
279.0 pg/mg creatinine
Standard Deviation 353.42
|
320.1 pg/mg creatinine
Standard Deviation 350.59
|
SECONDARY outcome
Timeframe: Month 12Population: n=4 deceased participants excluded from analysis. Participants with missing data excluded.
Change in respiratory function, as measured by spirometry (FEV1), at 12 months post-randomization.
Outcome measures
| Measure |
Standard Smoking Cessation
n=175 Participants
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.
|
Extended Nicotine Replacement Therapy
n=175 Participants
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.
|
|---|---|---|
|
Respiratory Function
|
55.4 % of predicted
Standard Deviation 19.25
|
56.8 % of predicted
Standard Deviation 19.78
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Respiratory Symptoms
Month 3
|
17.8 units on a scale
Standard Deviation 9.25
|
19.3 units on a scale
Standard Deviation 8.68
|
|
Respiratory Symptoms
Month 6
|
17.9 units on a scale
Standard Deviation 9.48
|
18.1 units on a scale
Standard Deviation 8.51
|
|
Respiratory Symptoms
Month 12
|
17.5 units on a scale
Standard Deviation 9.33
|
18.2 units on a scale
Standard Deviation 9.37
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis
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
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Respiratory-related Hospital Visits
Month 3 · 0 Visits
|
176 Participants
|
169 Participants
|
|
Respiratory-related Hospital Visits
Month 3 · 1 Visit
|
11 Participants
|
15 Participants
|
|
Respiratory-related Hospital Visits
Month 3 · 2 or more Visits
|
2 Participants
|
7 Participants
|
|
Respiratory-related Hospital Visits
Month 6 · 0 Visits
|
152 Participants
|
154 Participants
|
|
Respiratory-related Hospital Visits
Month 6 · 1 Visit
|
22 Participants
|
24 Participants
|
|
Respiratory-related Hospital Visits
Month 6 · 2 or more Visits
|
7 Participants
|
7 Participants
|
|
Respiratory-related Hospital Visits
Month 12 · 0 Visits
|
157 Participants
|
153 Participants
|
|
Respiratory-related Hospital Visits
Month 12 · 1 Visit
|
18 Participants
|
20 Participants
|
|
Respiratory-related Hospital Visits
Month 12 · 2 or more Visits
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Cardiac-related Hospital Visits
Month 3 · 1 Visit
|
7 Participants
|
6 Participants
|
|
Cardiac-related Hospital Visits
Month 3 · 2 or more Visits
|
1 Participants
|
0 Participants
|
|
Cardiac-related Hospital Visits
Month 3 · 0 Visits
|
181 Participants
|
185 Participants
|
|
Cardiac-related Hospital Visits
Month 6 · 0 Visits
|
171 Participants
|
180 Participants
|
|
Cardiac-related Hospital Visits
Month 6 · 1 Visit
|
10 Participants
|
4 Participants
|
|
Cardiac-related Hospital Visits
Month 6 · 2 or more Visits
|
0 Participants
|
1 Participants
|
|
Cardiac-related Hospital Visits
Month 12 · 0 Visits
|
175 Participants
|
167 Participants
|
|
Cardiac-related Hospital Visits
Month 12 · 1 Visit
|
8 Participants
|
12 Participants
|
|
Cardiac-related Hospital Visits
Month 12 · 2 or more Visits
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis. Missing responses were coded as smokers.
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
7-day Abstinence
Month 12, self-report
|
25 Participants
|
28 Participants
|
|
7-day Abstinence
Month 3, self-report
|
27 Participants
|
16 Participants
|
|
7-day Abstinence
Month 3, biochemically verified
|
25 Participants
|
14 Participants
|
|
7-day Abstinence
Month 6, self-report
|
28 Participants
|
20 Participants
|
|
7-day Abstinence
Month 6, biochemically verified
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Cotinine
Month 3
|
2652.5 ng/mg creatinine
Standard Deviation 2675.18
|
3378.1 ng/mg creatinine
Standard Deviation 3182.00
|
|
Cotinine
Month 6
|
2390.7 ng/mg creatinine
Standard Deviation 2842.07
|
3342.3 ng/mg creatinine
Standard Deviation 3282.48
|
|
Cotinine
Month 12
|
2159.0 ng/mg creatinine
Standard Deviation 2989.46
|
2363.7 ng/mg creatinine
Standard Deviation 2988.16
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis, non-smokers at each time point excluded
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Average Cigarettes Per Day (Continued Smokers Only)
Month 3
|
8.7 cigarettes per day
Standard Deviation 8.84
|
11.4 cigarettes per day
Standard Deviation 8.53
|
|
Average Cigarettes Per Day (Continued Smokers Only)
Month 6
|
9.1 cigarettes per day
Standard Deviation 8.62
|
9.9 cigarettes per day
Standard Deviation 9.52
|
|
Average Cigarettes Per Day (Continued Smokers Only)
Month 12
|
9.7 cigarettes per day
Standard Deviation 7.64
|
9.3 cigarettes per day
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants excluded from analysis, non-smokers at each time point excluded
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Carbon Monoxide Exposure (Continued Smokers Only)
Month 3
|
16.4 parts per million (ppm)
Standard Deviation 12.56
|
18.8 parts per million (ppm)
Standard Deviation 13.23
|
|
Carbon Monoxide Exposure (Continued Smokers Only)
Month 6
|
16.0 parts per million (ppm)
Standard Deviation 11.68
|
17.0 parts per million (ppm)
Standard Deviation 12.49
|
|
Carbon Monoxide Exposure (Continued Smokers Only)
Month 12
|
17.4 parts per million (ppm)
Standard Deviation 10.57
|
15.8 parts per million (ppm)
Standard Deviation 10.73
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Carcinogen Exposure (Continued Smokers Only)
Month 3
|
314.6 pg/mg creatinine
Standard Deviation 373.23
|
337.6 pg/mg creatinine
Standard Deviation 363.80
|
|
Carcinogen Exposure (Continued Smokers Only)
Month 6
|
219.8 pg/mg creatinine
Standard Deviation 236.30
|
217.1 pg/mg creatinine
Standard Deviation 251.82
|
|
Carcinogen Exposure (Continued Smokers Only)
Month 12
|
257.0 pg/mg creatinine
Standard Deviation 234.83
|
247.5 pg/mg creatinine
Standard Deviation 230.64
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 12Population: n=4 deceased participants were excluded from analysis, non-smokers at each time point excluded
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.
Outcome measures
| Measure |
Standard Smoking Cessation
n=197 Participants
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.
|
Extended Nicotine Replacement Therapy
n=197 Participants
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.
|
|---|---|---|
|
Cotinine (Continued Smokers Only)
Month 3
|
2771.2 ng/mg creatinine
Standard Deviation 2774.24
|
3305.8 ng/mg creatinine
Standard Deviation 2859.90
|
|
Cotinine (Continued Smokers Only)
Month 6
|
2850.7 ng/mg creatinine
Standard Deviation 2645.50
|
3502.2 ng/mg creatinine
Standard Deviation 2978.67
|
|
Cotinine (Continued Smokers Only)
Month 12
|
2733.9 ng/mg creatinine
Standard Deviation 2532.32
|
2782.7 ng/mg creatinine
Standard Deviation 2583.60
|
Adverse Events
Standard Smoking Cessation
Serious events: 9 serious events
Other events: 97 other events
Deaths: 1 deaths
Extended Nicotine Replacement Therapy
Serious events: 8 serious events
Other events: 163 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Standard Smoking Cessation
n=198 participants at risk
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.
|
Extended Nicotine Replacement Therapy
n=200 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.51%
1/198 • Number of events 1
|
1.5%
3/200 • Number of events 3
|
|
Cardiac disorders
Hospitalization for CHF
|
1.0%
2/198 • Number of events 2
|
1.0%
2/200 • Number of events 2
|
|
Cardiac disorders
Mesenteric Ischemia
|
0.00%
0/198
|
0.50%
1/200 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/198
|
0.50%
1/200 • Number of events 1
|
|
Cardiac disorders
TIA
|
0.51%
1/198 • Number of events 1
|
0.50%
1/200 • Number of events 1
|
|
Cardiac disorders
Revascularization
|
1.5%
3/198 • Number of events 3
|
0.00%
0/200
|
|
Cardiac disorders
Stroke
|
0.51%
1/198 • Number of events 1
|
0.00%
0/200
|
|
Cardiac disorders
Unstable angina
|
0.51%
1/198 • Number of events 1
|
0.00%
0/200
|
Other adverse events
| Measure |
Standard Smoking Cessation
n=198 participants at risk
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.
|
Extended Nicotine Replacement Therapy
n=200 participants at risk
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.
|
|---|---|---|
|
Product Issues
Local skin reactions
|
22.2%
44/198 • Number of events 89
|
40.5%
81/200 • Number of events 184
|
|
Product Issues
Upper GI symptoms
|
16.2%
32/198 • Number of events 42
|
31.0%
62/200 • Number of events 89
|
|
Product Issues
Sleep Disturbance
|
11.6%
23/198 • Number of events 25
|
20.5%
41/200 • Number of events 51
|
|
Product Issues
Oral discomfort
|
6.6%
13/198 • Number of events 14
|
13.0%
26/200 • Number of events 31
|
|
Product Issues
Headache
|
3.5%
7/198 • Number of events 10
|
9.0%
18/200 • Number of events 21
|
|
Product Issues
Change in affect or state of arousal
|
6.1%
12/198 • Number of events 13
|
10.0%
20/200 • Number of events 31
|
|
Product Issues
Cardiovascular symptoms
|
3.5%
7/198 • Number of events 9
|
6.5%
13/200 • Number of events 17
|
|
Product Issues
Hiccups
|
3.5%
7/198 • Number of events 8
|
5.5%
11/200 • Number of events 15
|
|
Product Issues
Muscle Aches
|
0.51%
1/198 • Number of events 1
|
3.0%
6/200 • Number of events 8
|
|
Product Issues
Bad Taste in Mouth
|
2.0%
4/198 • Number of events 5
|
5.5%
11/200 • Number of events 13
|
|
Product Issues
Dizziness
|
1.5%
3/198 • Number of events 3
|
5.5%
11/200 • Number of events 11
|
|
Product Issues
Increased Sweating
|
0.00%
0/198
|
3.5%
7/200 • Number of events 8
|
|
Product Issues
Diarrhea
|
2.0%
4/198 • Number of events 5
|
3.0%
6/200 • Number of events 8
|
Additional Information
Edward F. Ellerbeck, MD, MPH, Chair
Department of Preventive Medicine & Public Health
Phone: 913-588-2829
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place