Evaluation of a Novel Nicotine Inhaler Device. Part 2: Effect on Craving and Smoking Urges

Introduction: Many smokers find currently available nicotine replacement therapies unsatisfac - tory. The pharmacokinetics of nicotine delivered via a novel inhaler device, and its effect on craving satiation and smoking urges, were compared with the Nicorette® Inhalator (10 mg). Methods: Results are reported for Parts B (N = 24) and D (N = 24) of a 4-part Phase I study. Participants (18-55 years, ≥10 cigarettes/day within 1 hr of waking, expired carbon monoxide >10 ppm on screening) received single doses of nicotine on consecutive days (0.45 and 0.67 mg (Part B) and 0.45 mg (Part D) via the novel device; 10 mg via Nicorette® (Parts B and D)). Venous pharma- cokinetics, craving, and tolerability were assessed. Results: In Part B, the novel device 0.45 and 0.67 mg produced significantly lower C max , AUC last , and AUC all than Nicorette® (all p ≤ .05), higher AUC 0-10 and significantly shorter T max (18.7 and 19.2 min vs. 38.0 min, respectively, p ≤ .05). Craving score AUC was lower for the novel device 0.45 mg than for Nicorette® in Part B (1356.3 vs. 1566.3, p = .029) and approached statistical significance in Part D (1208.5 vs. 1402.3 (p = .059)). Mean craving scores were lower for the novel device 0.45 mg than Nicorette® at 7/8 postdose timepoints in Part B (p ≤ .05 at 180 and 240 min) and at all timepoints in Part D (p ≤ .05 at 2, 4, and 10 min). Conclusions: The novel device was at least as effective as the Nicorette® Inhalator (10 mg) in reliev- ing craving and smoking urges and was statistically superior at certain timepoints and in an overall craving AUC analysis, despite lower total nicotine exposure.