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Tobias Gibbs
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1 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: /jama 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.

2 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, (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%) (35.5%) 379 (41.6%) (94.1%) 608 (66.3%) < (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).

3 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).

4 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= (-10.4 to 3.7) P= (-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= (-11.4 to 3.9) P= (-8.5 to 4.6) P< (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= (-12.0 to 2.4) P= (-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= (-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.

5 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) a Latency to relapse=relapse within the first six months postquit; relapse defined as 7 consecutive days of smoking.

6 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

7 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) (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

8 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).

9 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 (75.1%) 331 (78.1%) 320 (76.0%) 299 (7%) (58.9%) 283 (66.7%) 260 (61.8%) 258 (6%) (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.

Supplementary Material

Supplementary Material Supplementary Table 1. Symptoms assessed, number of items assessed, scoring, and cut-off points for the psychiatric rating scales: Montgomery Åsberg Depression Rating Scale, Hamilton