Summary
Introduction
Nicotine replacement therapy (NRT) is an established aid for smoking cessation, but existing oral forms (e.g., gum) are not acceptable to all smokers.
A nicotine polacrilex lozenge was developed to provide a more acceptable oral NRT option with higher nicotine delivery than gum.
This study evaluated the efficacy and safety of 2-mg and 4-mg nicotine lozenges for smoking cessation.
Key Points
Study design: Large, randomized, double-blind, placebo-controlled trial including 1,818 adult smokers in the US and UK.
Dose stratification: Participants were assigned doses based on time to first cigarette (TTFC):
Low dependence → 2-mg lozenge
High dependence → 4-mg lozenge
Primary outcome: Continuous 28-day abstinence at 6 weeks, biochemically verified by carbon monoxide.
Efficacy results:
2-mg lozenge: 46.0% abstinence vs 29.7% placebo (OR 2.10)
4-mg lozenge: 48.7% abstinence vs 20.8% placebo (OR 3.69)
Treatment effects persisted through 52 weeks.
Dose–response: Higher lozenge use was associated with significantly higher quit rates.
Craving and withdrawal: Active lozenges significantly reduced craving and, for the 4-mg dose, withdrawal symptoms during early abstinence.
Weight gain: The 4-mg lozenge significantly reduced early post-cessation weight gain.
Safety profile:
Adverse events were mostly mild to moderate (nausea, hiccups, heartburn).
Serious adverse events were rare and not more frequent than placebo.
Safety was comparable to other oral NRT products.
Conclusion
Nicotine lozenges are a safe and effective treatment for smoking cessation in both low- and high-dependence smokers.
Matching nicotine dose to dependence level improves outcomes and reduces the risk of underdosing.
The lozenge expands NRT options by offering a well-tolerated, effective oral alternative to gum and other delivery forms.
Citation
Shiffman, Saul, et al. “Efficacy of a Nicotine Lozenge for Smoking Cessation.” Archives of Internal Medicine, vol. 162, no. 11, 2002, pp. 1267–1276.
