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. 2018 Apr 21:10.1111/add.14250.
doi: 10.1111/add.14250. Online ahead of print.

An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use

Paul M Cinciripini  1 , Jennifer A Minnix  1 , Charles E Green  2 , Jason D Robinson  1 , Jeffrey M Engelmann  3 , Francesco Versace  1 , David W Wetter  4 , Sanjay Shete  1 , Maher Karam-Hage  1
Affiliations

An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use

Paul M Cinciripini et al. Addiction. .

Abstract

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.

Keywords: Bupropion; combination pharmacotherapy; nicotine; smoking; smoking cessation; varenicline.

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Conflict of interest statement

Conflict of Interest Declaration: Dr. Cinciripini served on the scientific advisory board of Pfizer Pharmaceuticals, conducted educational talks sponsored by Pfizer on smoking cessation (2006–2008), and has received grant support and medication support from Pfizer. Dr. Karam-Hage participated in two multi-site Pfizer-funded trials and received varenicline from Pfizer to conduct 4 NIH-funded trials. Pfizer (New York, NY) provided the active and matching placebo varenicline capsules. All other authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials diagram for patient allocation. By design, the randomization ratio was 3:1 (Active: Placebo).
Figure 2
Figure 2
Study visit timeline. EOT indicates end of mediation treatment and final counseling session; IPC, in-person counseling; PC, phone counseling; IPF, in-person 3, 6, and 12-month post-quit follow-up
See this image and copyright information in PMC

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