Nicole L Nollen1, Lisa Sanderson Cox1, Matthew S Mayo2, Edward F Ellerbeck1, Jasjit S Ahluwalia3. 1. Department of Preventive Medicine and Public Health, University of Kansas School of Medicine, Kansas City, KS, USA. 2. Department of Biostatistics and Data Science, University of Kansas School of Medicine, Kansas City, KS, USA. 3. Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.
Abstract
BACKGROUND AND AIMS: One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy. DESIGN: Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING:Academic medical and federally qualified health centers in three US cities. PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling withnicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93). INTERVENTIONS: Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups. MEASUREMENTS: Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns. FINDINGS:Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P < 0.0001) but non-significant changes in cotinine (P = 0.69). C + NRT reported more days abstinent (P < 0.001) and fewer total cigarettes (P = 0.002) compared with C. There was no evidence of compensation with other tobacco products. CONCLUSIONS: Among black non-daily smokers in the United States, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT led to greater increase in days abstinent and reduction in cigarettes, with no evidence of compensation from other sources of nicotine.
RCT Entities:
BACKGROUND AND AIMS: One-third of US tobacco users are non-daily smokers (NDS). Black NDS have strikingly high levels of nicotine and carcinogen exposure. No smoking cessation studies have been conducted with this high-risk group. This study compared the effectiveness in black NDS of smoking cessation counseling alone or in combination with the participant's choice of nicotine replacement therapy. DESIGN: Two-arm parallel-group individually randomized clinical trial (allocation ratio of 2 : 1 intervention to control) SETTING: Academic medical and federally qualified health centers in three US cities. PARTICIPANTS: Non-Hispanic black adult NDS receiving counseling with nicotine replacement therapy (C + NRT, n = 185) or counseling alone (C, n = 93). INTERVENTIONS: Twelve weeks of in-person and telephone smoking cessation counseling in combination with nicotine replacement therapy (NRT; C + NRT) or counseling alone (C). All participants received five sessions of counseling; those randomized to C + NRT received their choice of nicotine gum, patch and/or lozenge after a 9-day product trial period. The target quit day was set at 2 weeks post-baseline for both groups. MEASUREMENTS: Primary outcome was biochemically verified 30-day abstinence at week 12. Secondary outcomes were change in nicotine and carcinogen exposure [4-(methynitrosamino)-1-(3) pyridyle-1-butanol; NNAL] and tobacco consumption patterns. FINDINGS: Abstinence was 11.4% in C + NRT and 8.6% in C [odds ratio (OR) = 1.4, 95% confidence interval (CI) = 0.6, 3.2, P = 0.48]. Both groups experienced significant reduction in NNAL (C + NRT: 53% reduction, C: 50% reduction, within-group P < 0.0001) but non-significant changes in cotinine (P = 0.69). C + NRT reported more days abstinent (P < 0.001) and fewer total cigarettes (P = 0.002) compared with C. There was no evidence of compensation with other tobacco products. CONCLUSIONS: Among black non-daily smokers in the United States, there was no difference in abstinence between nicotine replacement therapy (NRT) and counseling alone. NRT led to greater increase in days abstinent and reduction in cigarettes, with no evidence of compensation from other sources of nicotine.
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