A pilot study of nicotine delivery to smokers from a metered-dose inhaler.
BACKGROUND
The present study generated preliminary data on the acceptability and pharmacokinetics of nicotine administered by a simple metered-dose inhaler (MDI).


METHODS
We conducted a nonrandomized, open-label cross-over trial of 10 current smokers. On Day 1, a single cigarette was smoked ad libitum. On Day 2, participants took 10 puffs (20 inhalations) of 50 microg nicotine/puff through the inhaler, and on Day 3, they took 10 puffs (20 inhalations) of 100 microg nicotine/puff, each over 5 min. Nicotine pharmacokinetics, changes in heart rate and blood pressure, and the acceptability of the inhalers were measured and recorded.


RESULTS
Nicotine administered by an MDI produced a median maximum plasma concentration that was about 50% of that obtained by smoking a cigarette (12.5 vs. 25.9 ng/ml) and took twice the time to reach that concentration, 6 versus 3 min. Self-rated satisfaction and reduced urge to smoke were similar for the MDIs and a cigarette.


CONCLUSIONS
The results suggest that nicotine can be delivered effectively by the pulmonary route using a standard MDI. The inhaler appears to provide a satisfaction level and reduction in the urge to smoke relatively similar to that provided by smoking a cigarette. These conclusions require verification in a larger controlled study.
Department of Medicine, School of Medicine and Health Sciences, University of Otago, Wellington, Wellington South, New Zealand.
Brent
B
Caldwell
Stuart
S
Dickson
Carl
C
Burgess
Robert
R
Siebers
Sima
S
Mala
Adrienne
A
Parkes
Julian
J
Crane
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000493:pharmacokinetics / Q000494:pharmacology; D018722:Nicotinic Agonists / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology; D017060:Patient Satisfaction; D010865:Pilot Projects; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000188:drug therapy*; D055815:Young Adult
D018722:Nicotinic Agonists; D009538:Nicotine