Supplementary Online Content Baker TB, Piper ME, Stein JH, et al. Effects of nicotine patch vs varenicline vs combination nicotine replacement therapy on smoking cessation at 26 weeks: a randomized clinical trial. JAMA. doi:10.1001/jama.2015.19284 etable 1. Cohort Differences by Sociodemographic and Smoking-Related Variables etable 2. Covariate-Adjusted Logistic Regression Results for Initial Abstinence, Biochemically-Confirmed Abstinence Rates (CO Cutoff=5 ppm), and Prolonged Abstinence by Treatment Condition Contrasts etable 3. Biochemically-Confirmed Abstinence Rates (CO Cutoff=9 ppm) by Treatment Condition etable 4. Cox Regression Survival Analysis of Latency to Relapse in the First Six Months Postquit etable 5. A Priori Covariates and Week 26 Biochemically-Confirmed Point Abstinence (CO Cutoff=5 ppm) by Treatment Group etable 6. Medication Adherence in Past Week at Study Visits This supplementary material has been provided by the authors to give readers additional information about their work.
etable 1. Cohort Differences by Sociodemographic and Smoking-Related Variables Comparison of Cohorts Categorical Variables, No. (%) Cohort 1 (N=169) Cohort 2 (N=917) P-Value Site, No. (%) from Madison 48 (28.4%) 320 (34.9%).1012 Gender, No. (%) Female 89 (52.7%) 477 (52.0%).8774 Race, No. (%) White 130 (76.9%) 598 (65.2%).0029 Income, No. (%) <$20,0000 24 (15.5%) 321 (36.6%) <.0001 FTND 1 Item 1, No. (%) Smoking Within 30 Min of Waking Home Smoking, No. (%) Yes Prior Use of Cessation Medications b No. (%) Yes Menthol Smoking, No. (%) Yes 133 (80.6%) 703 (76.7%).2659 60 (35.5%) 379 (41.6%).1381 159 (94.1%) 608 (66.3%) <.0001 75 (44.6%) 472 (51.7%).0928 Continuous Variables, Mean (SD) Age (years) 52.6 (9.2) 47.3 (11.9) <.0001 Cigarettes per Day 17.4 (6.8) 17.0 (8.6).5092 FTND a Total Score 4.8 (2.0) 4.8 (2.1).9489 Exhaled Carbon Monoxide (ppm) 15.1 (6.5) 15.1 (8.7).9010 Years Smoked 33.1 (10.4) 27.8 (12.1) <.0001 Likelihood of Quitting Success c 5.7 (1.5) 5.5 (1.7).1409 Note. Cohort differences for categorical variables were tested via chi-square tests; cohort differences for continuous variables were tested with analysis of variance. a FTND=Fagerstrom Test of Nicotine Dependence (Heatherton et al, 1991); the FTND ranges from 0 to 10 with higher scores indicating a greater severity of nicotine dependence. b Prior Use of Cessation Medications=prior use of varenicline or nicotine patch, gum, or lozenge. c Likelihood of Quitting Success item was rated on 1 to 7 scale (1=not at all; 7=extremely).
etable 2. Covariate-Adjusted Logistic Regression Results for Initial Abstinence, Biochemically-Confirmed Abstinence Rates (CO Cutoff=5 ppm), and Prolonged Abstinence by Treatment Condition Contrasts Post-Quit Abstinence Measure Primary Outcome: Abstinence at 26 Weeks a Initial Covariate-Adjusted Odds Ratio (95% Cl) d Patch vs. Patch vs. C-NRT e vs. C-NRT e 1.1 (0.8 to 1.7) 0.8 Abstinence b (0.5 to 1.1) Abstinence at 4 (0.8 to 1.8) Weeks a Abstinence at 12 Weeks a Abstinence at 52 Weeks a Prolonged Abstinence c (26 Weeks) 1.5 ( to 2.3) 9 (0.7 to 1.5) (0.8 to 2.2) ( to 1.9) 1.4 (5 to 2.1) (0.8 to 1.7) ( to 1.9) (0.7 to 1.5) (0.8 to 2.0) (0.6 to ) 0.6 (0.4 to 0.8) (0.8 to 1.4) ( to 1.7) (0.7 to 1.4) 1.1 (0.8 to 1.7) a Abstinence self-report was biochemically confirmed via exhaled carbon monoxide (CO) testing with abstinence confirmed with a CO value of 5 parts per million (ppm). b Initial abstinence = achieving at least 24 hour of abstinence in the first week of treatment. c Prolonged abstinence = no smoking from Day 7 to Day 181 after the target quit day. d Covariate-adjusted odds ratios based on logistic regression models that included the following binary covariates: Cohort (0=Cohort1, 1=Cohort2), Site (0=Madison, 1=Milwaukee), Gender (0=Female, 1=Male), Race (0=Non-White, 1=White), Income (0=<$20,000, 1= $20,000, FTND Total Score (0=0-4, 1=5-10), Likelihood of Quitting (0=1-5, 1=6-7), Age (0=18-49, 1=50+), Baseline Exhaled Carbon Monoxide (0=5-14, 1=15+0, Home Smoking (0=No, 1=Yes), Prior Use of Cessation Medications (0=No, 1=Yes), Menthol Smoking (0=No, 1=Yes), FTND Item 1 (0=Smoke > 30 Minutes After Waking, 1=Smoke Within 30 Minutes of Waking. e C-NRT = Combination Nicotine Replacement Therapy ( and Nicotine Lozenge).
etable 3. Biochemically-Confirmed Abstinence Rates (CO Cutoff=9 ppm) by Treatment Condition Post-Quit Abstinence Measure Treatment Group Abstinence Rates, N Abstinent (%) Abstinence Difference P-Value c Unadjusted Odds Ratio (95% Cl) d Nicotine Patch (N=241) (N=424) (N=421) Patch vs. Patch vs. vs. Patch vs. Patch vs. vs. Primary Outcome: Abstinence at 26 Weeks a 63 (26.1%) 108 (25.5%) 124 (29.5%) -0.6 (-6.3 to 7.6) P=.8494-3.3 (-10.4 to 3.7) P=.3623-4.0 (-10.0 to 2.0) P=.1947 (0.7 to 1.4) (0.8 to 1.7) (0.6 to ) Abstinence at 4 Weeks a 86 (35.7%) 159 (37.5%) 166 (39.4%) -1.8 (-9.4 to 5.8) P=.6409-3.8 (-11.4 to 3.9) P=.3396-1.9 (-8.5 to 4.6) P<.5642 1.1 (0.8 to 1.5) 1.1 ( to 1.6) (0.7 to ) Abstinence at 12 Weeks a 68 (28.2%) 146 (34.4%) 139 (33.0%) -6.2 (-13.5 to ) P=.0990-4.8 (-12.0 to 2.4) P=.1998 1.4 (-5.0 to 7.8) P=.6630 ( to 1.9) ( to 1.8) ( to 1.6) Abstinence at 52 Weeks a 52 (21.6%) 85 (20.1%) 87 (20.7%) 1.5 (-4.9 to 8.0) P=.6392 (-5.6 to 7.4) P=.7819-0.6 (-6.1 to 4.8) P=.8235 (0.6 to ) (0.6 to 1.4) (0.7 to 1.4) a Abstinence self-report was biochemically confirmed via exhaled carbon monoxide (CO) testing with abstinence confirmed with a CO value of 9 parts per million (ppm). b C-NRT = Combination Nicotine Replacement Therapy ( and Nicotine Lozenge). c Pairwise comparisons of Abstinence s were tested via Proc Freq (SAS Institute) by specifying the RISKDIFF option which provides standard Wald asymptotic confidence limits for the risks. d Unadjusted odds ratios based on logistic regression analysis.
etable 4. Cox Regression Survival Analysis of Latency to Relapse in the First Six Months Postquit Latency to Relapse a Treatment Group Hazard Ratio p-value (Reference Category) - - + Nicotine Lozenge 43 (0.78 to 1.14) 15 (0.76 to 1.11).5543.3613 a Latency to relapse=relapse within the first six months postquit; relapse defined as 7 consecutive days of smoking.
etable 5. A Priori Covariates and Week 26 Biochemically-Confirmed Point Abstinence (CO Cutoff=5 ppm) by Treatment Group Variable Week 26 CO-Confirmed Point Abstinence Variable Coding No. Abstinent/Total (%) C-NRT e Vs. Vs. C-NRT e Cohort Cohort 1 (N=169) 11/32 (34.4%) 13/65 (20.0%) 25/72 (34.7%) 14.4 (-4.7 to 33.5) -0.3 (-20.1 to 19.5) Cohort 2 (N=917) 44/209 (21.1%) 87/359 (24.2%) 88/349 (25.2%) -3.2 (-10.3 to 3.9) -4.2 (-1 to 3.0) Site Madison (N=368) 17/79 (21.5%) 40/146 (27.4%) 43/143 (30.1%) -5.9 (117.5 to 5.7) -8.6 (-20.3 to 3.2) Milwaukee (N=718) 38/162 (23.5%) 60/278 (21.6%) 70/278 (25.2%) 1.9 (-6.3 to 10.0) -1.7 (-10.0 to 6.6) Gender Female (N=566) 28/125 (22.4%) 49/222 (22.1%) 61/219 (27.9%) 0.3 (-8.8 to 9.5) -5.5 (-14.9 to 4.0) Male (N=520) 27/116 (23.3%) 51/202 (25.3%) 52/202 (25.7%) -2.0 (-11.7 to 7.8) -2.5 (-12.2 to 7.3) Race Non-White (N=358) 11/83 (13.3%) 25/141 (17.7%) 24/134 (17.9%) -4.5 (-14.1 to 5.2) -4.7 (-14.4 to 5.1) White (N=728) 44/158 (27.9%) 75/283 (26.5%) 89/287 (3%) 1.4 (-7.3 to 10.0) -3.2 (-12.0 to 5.6) Income <$20,0000 (N=345) 17/80 (2%) 20/131 (15.3%) 29/134 (21.6%) 6.0 (-4.9 to 16.9) -0.3 (-11.8 to 1) $20,000 (N=688) 35/148 (23.7%) 77/275 (28.0%) 79/265 (29.8%) -4.4 (-13.0 to 4.3) -6.2 (-15.0 to 2.6) Total N=1033
Variable Week 26 CO-Confirmed Point Abstinence Variable Coding No. Abstinent/Total (%) C-NRT e Vs. Vs. C-NRT e FTND a Total Score 0-4 (N=463) 24/94 (25.5%) 58/182 (31.9%) 48/187 (25.7%) -6.3 (-17.5 to 4.8) -0.2 (-1 to 10.7) 5-10 (N=618) 31/147 (21.1%) 41/239 (17.2%) 63/232 (27.2%) 3.9 (-4.2 to 12.1) -6.1 (-14.8 to 2.7) Total N=1081 Likelihood of Quitting b 1-5 (N=425) 18/88 (20.5%) 30/170 (17.7%) 36/167 (21.6%) 2.8 (-7.4 to 13.0) -1.1 (-11.6 to 9.4) 6-7 (N=645) 35/149 (23.5%) 68/245 (27.8%) 76/251 (30.3%) -4.3 (-13.1 to 4.6) -6.8 (-15.7 to 2.1) Total N=1070 Age (years) 18-49 (N=521) 26/109 (23.9%) 43/222 (19.4%) 48/190 (25.3%) 4.5 (-5.1 to 14.0) -1.4 (-11.5 to 8.7) 50+ (N=565) 29/132 (22.0%) 57/202 (28.2%) 65/231 (28.1%) -6.3 (-15.7 to 3.2) -6.2 (-15.3 to 3.0) Carbon Monoxide (ppm) 5-14 (N = 616) 36/139 (25.9%) 59/236 (25.0%) 69/241 (28.6%) (-8.2 to 10.0) -2.7 (-12.0 to 6.5) 15+ (N=470) 19/102 (18.6%) 41/188 (21.8%) 44/180 (24.4%) -3.2 (-1.8 to 6.4) -5.8 (-15.6 to 4.0) Home Smoking c No (N=641) 38/143 (26.6%) 67/256 (26.2%) 68/242 (28.1%) 0.4 (-8.6 to 9.4) -1.5 (-10.7 to 7.7) Yes (N=439) 17/98 (17.4%) 32/165 (19.4%) 44/176 (25.0%) -2.1 (-11.7 to 7.6) -7.7 (-17.5 to 2.2) Total N=1080
Variable Week 26 CO-Confirmed Point Abstinence Variable Coding No. Abstinent/Total (%) C-NRT e Vs. Vs. C-NRT e Prior Use of Cessation of Medications d No (N=319) 19/78 (24.4%) 21/119 (17.7%) 29/122 (23.8%) 6.7 (-5.0 to 18.4) 0.5 (-11.6 to 12.8) Yes (N=767) 36/163 (22.1%) 79/305 (25.9%) 84/299 (28.1%) -3.8 (-11.9 to 4.2) -6.0 (-14.2 to 2.2) Menthol Smoking No (N=534) 34/125 (27.2%) 55/197 (27.9%) 72/212 (34.0%) -0.7 (-10.7 to 9.3) -6.8 (-16.8 to 3.30 Yes (N=547) 21/115 (18.3%) 44/224 (19.6%) 40/208 (19.2%) -1.4 (-10.2 to 7.4) - (-9.8 to 7.9) Total N=1081 FTND a Item 1 Smoke > 30 Min (N=246) 19/53 (35.9%) 31/99 (3%) 29/94 (3%) 4.5 (-1 to 20.4) 5.0 (-1 to 2) Smoke Within 30 Min of Waking (N=836) 36/188 (19.2%) 69/324 (2%) 82/324 (25.3%) -2.2 (-9.3 to 5.0) -6.2 (-13.5 to ) Total N=1082 a FTND=Fagerstrom Test of Nicotine Dependence. 19 b Likelihood of Quitting Success item was rated on 1 to 7 scale (1=not at all; 7=extremely). c Home Smoking=presence (No/Yes) of any smokers living in the home of the participant. d Prior Cessation Medication Use=prior use of varenicline or nicotine patch, gum, or lozenge. e C-NRT = Combination Nicotine Replacement Therapy ( and Nicotine Lozenge).
etable 6. Medication Adherence in Past Week at Study Visits No. (%) Post-Quit Week Only (N=241) (N=424) + Nicotine Lozenge (N=421) Patch Adherence Pill Adherence Patch Adherence Lozenge Adherence 1 181 (75.1%) 331 (78.1%) 320 (76.0%) 299 (7%) 4 142 (58.9%) 283 (66.7%) 260 (61.8%) 258 (6%) 8 109 (45.2%) 209 (49.3%) 209 (49.6%) 181 (43.0%) Past week adherence for the patch was defined as using one patch per day for 6 or 7 days; adherent use of varenicline was defined as taking 1 or 2 pills per day for 6 or 7 days; and adherent use of the lozenge was defined as using at least 2 lozenges per day for 6 or 7 days.