Comparative effects of varenicline or combination nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt

• Published in: Addiction (Abingdon, England) England), 2021-04, Vol.116 (4), p.926-935
• Main Authors: Kim, Nayoung, McCarthy, Danielle E., Piper, Megan E., Baker, Timothy B.
• Format: Article
• Language: English
• Subjects: Abstinence; Adult; Candidates; Cigarette smoking; Combination nicotine replacement therapy; Combination therapy; Community health services; Community research; Counseling; Craving; Drug addiction; Ecological momentary assessment; Expectancy; Female; Humans; Indirect effects; Male; Mediation; Middle Aged; Motivation; Nicotine; nicotine lozenge; nicotine patch; Nicotine replacement therapy; nicotine withdrawal; Smokers; Smoking; Smoking Cessation; Therapy; Tobacco Use Cessation Devices; Treatment methods; Treatment needs; Treatment Outcome; varenicline; Varenicline - therapeutic use; Withdrawal symptoms
• ISSN: 0965-2140; 1360-0443
• DOI: 10.1111/add.15248

Background and aims The phase‐based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre‐cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C‐NRT) relative to nicotine patch monotherapy on pre‐cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators. Design Secondary mediation analysis of data from the open‐label, randomized Wisconsin Smokers’ Health Study 2, a comparative effectiveness trial of varenicline or C‐NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach. Setting Research clinics in Madison and Milwaukee, Wisconsin, USA. Participants A total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6). Interventions Twelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling. Measurements The primary abstinence outcome was biochemically verified 7‐day point‐prevalence abstinence 4 weeks post‐target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre‐cessation phase) to 4 weeks after (cessation phase) the TQD. Findings Pre‐cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34–0.79], smoking expectancies (aOR = 0.46–0.79) and quitting motivation (aOR = 1.35–7.21) significantly predicted 4‐week post‐TQD abstinence (P