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Smoking Cessation Strategies After Initial Treatment Failure
Quick Takes
- Smokers initially receiving combined nicotine replacement therapy (CNRT), who continued to smoke and were rerandomized to an increased dosage or changed to varenicline, had a greater probability of cessation.
- Smokers initially receiving varenicline, who continued to smoke and were rerandomized to an increased dosage, had a greater probability of cessation.
- The secondary outcome of continuous abstinence at 6 months indicated that only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages.
Study Questions:
Does treatment with varenicline or combined nicotine replacement therapy (CNRT) improve smoking cessation rates among smokers who do not quit on their initial attempt?
Methods:
A double-blind, placebo-controlled sequential multiple assignment randomized trial (SMART) design was used to examine use of 6 weeks of varenicline or CNRT for smoking cessation. After 6 weeks, nonabstainers were rerandomized to continue, switch, or increase medication dosage for 6 additional weeks. Volunteers seen in a Texas tobacco treatment clinic were included in the trial conducted from June 2015 through October 2019. The interventions included an initial treatment of varenicline 2 mg/d or CNRT of a 21 mg patch plus 2 mg lozenge. Rerandomized participants either continued with their initial therapies, switched between varenicline and CNRT, or increased dosages either to ≥3 mg of varenicline or to a 42 mg patch and lozenges. All participants received weekly brief counseling. The primary outcome of interest was biochemically verified 7-day point prevalence abstinence at the end of treatment at 12 weeks.
Results:
A total of 490 participants (mean age 48.1 years, 210 females [43%], 287 non-Hispanic White [58%]) were included in the present study. Average number of cigarettes smoked was 20 cigarettes per day. After the first phase (6 weeks), 54 participants in the CNRT group were abstinent and continued their therapy. Of the 191 who were not abstinent, 151 were rerandomized, and the 40 who did not return for rerandomization were assigned to continue their initial CNRT condition during phase 2. The end-of-treatment abstinence rate for the 191 phase 1 nonabstainers was 8% (95% credible interval [CrI], 6%-10%) for the 90 (47%) who continued at the dosage condition, 14% (95% CrI, 10%-18%) for the 50 (33%) who increased their dosage, and 14% (95% CrI,10%-18%) for the 51 (34%) who switched to varenicline (absolute risk difference, 6%; 95% CrI, 6%-11%) with >99% posterior probability that either strategy conferred benefit over continuing the initial dosage.
After the first phase, 88 participants in the varenicline group were abstinent and continued their therapy. Of the 157 who were not abstinent, 122 were rerandomized and 35 who did not return for rerandomization were assigned to continue with the varenicline condition. The end-of-treatment abstinence rate for the 157 phase 1 nonabstainers was 20% (95% CrI, 16%-26%) for the 39 (32%) who increased their varenicline dosage, 0 (95% CrI, 0-0) for the 41 (34%) who switched CNRT, and 3% (95% CrI,1%-4%) for the 77 (49%) who were assigned to the continued varenicline condition (absolute risk difference, −3%; 95% CrI, −4% to −1%) with >99% posterior probability that continuing varenicline at the initial dosage was worse than switching to a higher dosage. Furthermore, increasing the varenicline dosage had an absolute risk difference of 18% (95% CrI, 13%-24%) and a >99% posterior probability of conferring benefit. The secondary outcome of continuous abstinence at 6 months indicated that only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages.
Conclusions:
The authors conclude that for individuals who smoked but did not achieve abstinence after treatment with varenicline, increasing the dosage enhanced abstinence versus continuing, whereas for nonabstainers initially treated with CNRT, a dosage increase or switch to varenicline enhanced abstinence and may be viable rescue strategies.
Perspective:
Smoking cessation is challenging with many smokers attempting to quit multiple times. This trial used a study design to examine different strategies and the associated abstinence rates. This equips providers with useful information to use for increasing doses of CNRT or varenicline among patients who are actively attempting to quit but have continued to smoke after an initial quit attempt.
Clinical Topics: Prevention
Keywords: Smoking Cessation, Tobacco Use Cessation Devices, Varenicline
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