Mayo Clin Proc

What to do when a first attempt at smoking cessation fails

May 3, 2024

For individuals who don’t achieve abstinence after treatment with varenicline, increasing the dosage increases odds of abstinence compared with continuing at the initial dosage. For those who don’t achieve abstinence with combined nicotine replacement therapy (CNRT), a dosage increase or switch to varenicline enhanced abstinence.

In this double-blind, placebo-controlled, sequential multiple assignment randomized trial, 490 volunteers (43% female; 58% non-Hispanic White; mean age, 48.1 years) who smoked an average of 20 cigarettes per day were randomized to receive 6 weeks of varenicline (2 mg/day) or CNRT (21-mg patch plus 2-mg lozenge). After 6 weeks, those who were still smoking were re-randomized to continue, switch, or increase medication dosage (3-mg or more of varenicline or 42-mg patch and lozenges) for 6 additional weeks. All received weekly brief counseling. Main outcome was biochemically verified 7-day point prevalence abstinence at the end of treatment at 12 weeks.

After the first phase, 54 participants in the CNRT group were abstinent and continued their therapy; of the 191 who weren’t abstinent, 151 were re-randomized, and the 40 who didn’t return for re-randomization were assigned to continue their initial CNRT in phase 2. End-of-treatment abstinence rates for the 191 phase 1 nonabstainers were as follows:

• 8% for those who continued the initial dosage
• 14% for those who increased their dosage
• 14% for those who switched to varenicline

After the first phase, 88 participants in the varenicline group were abstinent and continued their therapy; of the 157 who weren’t abstinent, 122 were re-randomized, and 35 who didn’t return for re-randomization were assigned to continue their initial varenicline therapy. End-of-treatment abstinence rates for the 157 phase 1 nonabstainers were as follows:

• 20% for those who increased their varenicline dosage
• 0 for those who switched CNRT
• 3% for those who continued the initial varenicline dosage

The secondary outcome of continuous abstinence at 6 months indicated that only increased dosages of CNRT and varenicline yielded benefit over continuation of the initial treatment dosages.

Source:

Cinciripini PM, et al. (2024, May 2). JAMA. Smoking Cessation After Initial Treatment Failure With Varenicline or Nicotine Replacement: A Randomized Clinical Trial
https://pubmed.ncbi.nlm.nih.gov/38696203/