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An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use
Author(s) -
Cinciripini Paul M.,
Minnix Jennifer A.,
Green Charles E.,
Robinson Jason D.,
Engelmann Jeffrey M.,
Versace Francesco,
Wetter David W.,
Shete Sanjay,
KaramHage Maher
Publication year - 2018
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/add.14250
Subject(s) - varenicline , abstinence , bupropion , medicine , smoking cessation , randomized controlled trial , odds ratio , placebo , confidence interval , nicotine replacement therapy , psychiatry , alternative medicine , pathology
Background and Aims Despite the availability of several efficacious smoking cessation treatments, fewer than 25% of smokers who quit remain abstinent 1 year post‐treatment. This study aimed to determine if varenicline and bupropion combination treatment would result in higher abstinence rates than varenicline alone. Design A double‐blind, randomized, parallel‐group smoking cessation clinical trial in which participants were exposed to 12 weeks of treatment and followed for 12 months. Setting Hospital‐based out‐patient clinic in Texas, USA specializing in cancer prevention. Participants A total of 385 community smokers (58.44% male) who smoked 1 pack of cigarettes/day [mean = 19.66 cigarettes/day, standard deviation (SD) = 9.45]; had average carbon monoxide (CO) of 26.43 parts per million (SD = 13.74); and were moderately dependent (Fagerström Test for Cigarette Dependence = 4.79; SD = 2.07). Interventions and comparator Smokers were randomized in a 3 : 1 (active: Placebo) ratio to 12 weeks of treatment as follows: placebo ( n = 56), varenicline (Var; n = 166), and varenicline + bupropion (Combo; n = 163). Measurements A priori primary outcome: prolonged abstinence at 12 months. Secondary outcomes: 7‐day point prevalence abstinence and continuous abstinence; all abstinence measures at end of treatment and 6‐month follow‐ups. Findings Intention‐to‐treat analysis: the Combo group ( n = 163) failed to demonstrate superiority to the Var group ( n = 166) for prolonged abstinence at 12 months [odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.50–1.64], supported by Bayes factor = 0.06. Both the Var (OR = 6.66, 95% CI = 1.61–59.27) and Combo groups (OR = 6.06, 95% CI = 1.45–54.09) demonstrated superiority to the Placebo group ( n = 56; score = 8.38, P < 0.016). Conclusions The addition of bupropion to varenicline treatment does not appear to increase smoking abstinence rates above that of varenicline alone. The findings support previous research showing a consistently favorable effect of both varenicline and the combination of varenicline and bupropion on smoking cessation compared with placebo.