Evaluation of a novel nicotine inhaler device: Part 2-effect on craving and smoking urges

C. Moyses, A. Hearn, Andrew Redfern

    Research output: Contribution to journalArticlepeer-review

    8 Citations (Scopus)


    © The Author 2014. Introduction: Many smokers find currently available nicotine replacement therapies unsatisfactory. 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 pharmacokinetics, craving, and tolerability were assessed. Results: In Part B, the novel device 0.45 and 0.67 mg produced significantly lower Cmax, AUClast, and AUCall than Nicorette® (all p ≤ .05), higher AUC0-10 and significantly shorter Tmax (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 relieving craving and smoking urges and was statistically superior at certain timepoints and in an overall craving AUC analysis, despite lower total nicotine exposure.
    Original languageEnglish
    Pages (from-to)26-33
    JournalNicotine and Tobacco Research
    Issue number1
    Publication statusPublished - 2015


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