Problem/Objective: Cigarette craving is a major factor in the failure of smoking cessation treatment; thus products that could reduce or eliminate craving may improve quit rates. Our goal was to test whether deep lung delivery of inhaled nicotine using an aqueous-based inhaler (AERx Essence, Aradigm Corporation) would reduce craving.

Methods: The trial was a randomized, open-label study to evaluate inhaled nicotine in the AERx Essence in 18 adult male smokers. Following initial tolerability testing, subjects were randomized to receive one of three nicotine bolus lung doses of approximately 0.2, 0.4 and 0.7 mg, respectively. Study measurements included arterial plasma pharmacokinetics and assessment of acute cigarette craving (0 to 10 VAS) before and after dosing.

Results: Inhaled nicotine via the AERx Essence was safe and tolerable. Pharmacokinetic parameters were consistent with rapid delivery and absorption of nicotine from the lung comparable to cigarette smoking. Mean craving scores pre-dose for the three doses were 5.5, 5.5, and 5.0. Post-dose, mean craving scores at 5 minutes were 1.3, 1.7, and 1.3, respectively. Combining all dose levels, craving declined from a mean of 4.9 to 1.4 within 5 minutes post-dosing, and did not return to pre-dose baseline in the 4 hours of monitoring. Nearly all subjects reported an acute reduction in craving or an absence of craving immediately following inhalation.

Conclusions: Delivery of nicotine in AERx Essence reduces craving and could aid cigarette smoking cessation.