Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation.
Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored.
Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: -41.8; 95% confidence interval [CI]: -45.8, -37.7) versus placebo (-25.9; 95% CI: -30.0, -21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges.
Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.
Trial registration: ClinicalTrials.gov NCT01466361 NCT01506908.