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

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Abstract

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 (10mg).

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 1hr of waking, expired carbon monoxide >10 ppm on screening) received single doses of nicotine on consecutive days (0.45 and 0.67mg [Part B] and 0.45mg [Part D] via the novel device; 10mg via Nicorette® [Parts B and D]). Venous pharmacokinetics, craving, and tolerability were assessed.

Results:

In Part B, the novel device 0.45 and 0.67mg produced significantly lower Cmax, AUClast, and AUCall than Nicorette® (all p ≤ .05), higher AUC0-10 and significantly shorter Tmax (18.7 and 19.2min vs. 38.0min, respectively, p ≤ .05). Craving score AUC was lower for the novel device 0.45mg 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 0.45mg than Nicorette® at 7/8 postdose timepoints in Part B (p ≤ .05 at 180 and 240min) and at all timepoints in Part D (p ≤ .05 at 2, 4, and 10min).

Conclusions:

The novel device was at least as effective as the Nicorette® Inhalator (10mg) 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.

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