title: Evaluation of a novel nicotine inhaler device: part 2--effect on craving and smoking urges.
abstract: BACKGROUND
  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 C max, AUClast, and AUCall than Nicorette® (all p ≤ .05), higher AUC0-10 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 (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.
authors.affiliation: Kind Consumer Limited, London, UK; chris.moyses@kindconsumer.com.
authors.forename: Chris
authors.initials: C
authors.lastname: Moyses
authors.affiliation: Kind Consumer Limited, London, UK;
authors.forename: Alex
authors.initials: A
authors.lastname: Hearn
authors.affiliation: Linear Clinical Research Limited, Perth, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Redfern
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D019540:Area Under Curve; D066249:Craving; D005260:Female; D006801:Humans; D008168:Lung / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D009538:Nicotine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*
chemical_list: D009538:Nicotine
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