Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation

Abstract

IMPORTANCE Smoking cessation medications are routinely used in health care. Research suggests that combining varenicline with the nicotine patch, extending the duration of varenicline treatment, or both, may increase cessation effectiveness.OBJECTIVE To compare combinations of varenicline plus the nicotine or placebo patch vs combinations used for either 12 weeks (standard duration) or 24 weeks (extended duration).DESIGN, SETTINGS, AND PARTICIPANTS Double-blind, 2 × 2 factorial randomized clinical trial conducted from November 11, 2017, to July 9, 2020, at 1 research clinic in Madison, Wisconsin, and at 1 clinic in Milwaukee, Wisconsin. Of the 5836 adults asked to participate in the study, 1251 who smoked 5 cigarettes/d or more were randomized.INTERVENTIONS All participants received cessation counseling and were randomized to 1 of 4 medication groups: varenicline monotherapy for 12 weeks (n = 315), varenicline plus nicotine patch for 12 weeks (n = 314), varenicline monotherapy for 24 weeks (n = 311), or varenicline plus nicotine patch for 24 weeks (n = 311). MAIN OUTCOMES AND MEASURESThe primary outcome was carbon monoxide-confirmed self-reported 7-day point prevalence abstinence at 52 weeks. RESULTS Among 1251 patients who were randomized (mean [SD] age, 49.1 [11.9] years; 675 [54.0%] women), 751 (60.0%) completed treatment and 881 (70.4%) provided final follow-up. For the primary outcome, there was no significant interaction between the 2 treatment factors of medication type and medication duration (odds ratio [OR], 1.03 [95% CI, 0.91 to 1.17]; P = .66). For patients randomized to 24-week vs 12-week treatment duration, the primary outcome occurred in 24.8% (154/622) vs 24.3% (153/629), respectively (risk difference, −0.4% [95% CI, −5.2% to 4.3%]; OR, 1.01 [95% CI, 0.89 to 1.15]). For patients randomized to varenicline combination therapy vs varenicline monotherapy, the primary outcome occurred in 24.3% (152/625) vs 24.8% (155/626), respectively (risk difference, 0.4% [95% CI, −4.3% to 5.2%]; OR, 0.99 [95% CI, 0.87 to 1.12]). Nausea occurrence ranged from 24.0% to 30.9% and insomnia occurrence ranged from 24.4% to 30.5% across the 4 groups.CONCLUSIONS AND RELEVANCE Among adults smoking 5 cigarettes/d or more, there were no significant differences in 7-day point prevalence abstinence at 52 weeks among those treated with combined varenicline plus nicotine patch therapy vs varenicline monotherapy, or among those treated for 24 weeks vs 12 weeks. These findings do not support the use of combined therapy or of extended treatment duration.

Evaluation of factors affecting smoking cessation in people treated with Varenicline

“…According to the results of another study, it was reported that Varenicline in combination with nicotine replacement was more effective than Varenicline alone in the treatment of tobacco withdrawal (22). In the study of Baker et al, there was no significant difference in the prevalence of smoking cessation between those treated with varenicline and nicotine patches and those treated with varenicline monotherapy (23). Therefore, it appears that adding nicotine replacement therapy to varenicline treatment should be decided on Those with high nicotine addiction have difficulty quitting smoking compared to those with lower addiction levels (24).…”

E-cigarettes to Augment Stop Smoking In-person Support and Treatment With Varenicline (E-ASSIST): A Pragmatic Randomized Controlled Trial

“… 12 However, another recent study showed that adding nicotine patches to varenicline had little effect on abstinence rates (OR 0.99, 95% CI .87–1.12). 30 It is possible that fast-acting nicotine products—including gums, sprays, and e-cigarettes—are better at helping varenicline users remain abstinent, as they can satisfy momentary urges for nicotine. 31 Moreover, the behavior and sensory experience of using an e-cigarette is similar to that of smoking a cigarette, which could make e-cigarette more effective for smoking cessation than other nicotine products.…”

E-cigarettes With Varenicline Versus Varenicline for Smoking Cessation: A Pragmatic Randomised Controlled Trial

“…12 However, another recent study showed that adding nicotine patches to varenicline had little effect on abstinence rates (OR 0.99, 95% CI 0.87-1.12). 30 It is possible that fast acting nicotine products — including gums, sprays, e-cigarettes — are better at helping varenicline users remain abstinent, as they can satisfy momentary urges for nicotine. 31…”