For Individuals Who Do Not Initially Achieve Smoking Cessation With Varenicline, Increasing the Dose May Help

Varenicline and combined nicotine replacement therapy (CNRT) are effective for smoking cessation, but most people do not achieve abstinence on their initial attempt. In this trial, participants who wanted to quit combustible cigarette smoking (N=490) were initially randomized to 2 mg/day of varenicline or CNRT (21 mg patch + 2 mg lozenges). After six weeks, those receiving varenicline who did not achieve smoking abstinence were re-randomized to varenicline 2 mg or 3 mg/day, or CNRT. Participants receiving CNRT who did not achieve smoking abstinence at six weeks were re-randomized to varenicline 2 mg/day, or CNRT with one or two 21 mg patches. The primary outcome was biochemically verified seven-day abstinence at the end of 12 weeks.

  • At the end of the first six-week phase, abstinence was achieved by 36 percent of participants assigned to varenicline and 22 percent of those assigned to CNRT.
  • For those who did not initially achieve abstinence with varenicline 2 mg/day, 12-week abstinence rates were 20 percent for those who subsequently received varenicline 3 mg/day, 0 percent for those receiving CNRT, and 3 percent for those receiving varenicline 2 mg/day.
  • For those who did not initially achieve abstinence with CNRT, 12-week abstinence rates were 14 percent for those who subsequently received varenicline 2 mg/day, 14 percent for those receiving higher-dose CNRT, and 8 percent for those receiving continued CNRT.

Comments: For individuals whose smoking cessation efforts are initially unsuccessful with standard-dose varenicline, a higher dose should be offered. For those who are unsuccessful with CNRT, a switch to varenicline or higher-dose CNRT are reasonable options.

Darius A. Rastegar, MD

Reference: Cinciripini PM, Green CE, Shete S, et al. Smoking cessation after initial treatment failure with varenicline or nicotine replacement: a randomized clinical trial. JAMA. 2024;33:1722–1731.

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