PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of bmjoInstructions for authorsCurrent ToCBMJ Open
 
BMJ Open. 2012; 2(5): e001618.
Published online Sep 26, 2012. doi:  10.1136/bmjopen-2012-001618
PMCID: PMC3467658
Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial
Anna Hansson,1 Peter Hajek,2 Roland Perfekt,3 and Holger Kraiczi1
1Department of Clinical Pharmacology, McNeil AB, Lund, Sweden
2Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, London, UK
3Global Biometrics and Clinical Data Systems, McNeil AB, Helsingborg, Sweden
Correspondence to Dr Anna Hansson;  AHansson/at/its.jnj.com
Received June 12, 2012; Accepted August 30, 2012.
Abstract
Objective
A new nicotine mouth spray was shown to be an effective stop-smoking treatment. This study was set up to examine the speed with which it relieves urges to smoke, and how it compares with nicotine lozenge in this respect.
Design
Randomised, cross-over trial that compared nicotine mouth spray 2 mg versus nicotine lozenge 2 or 4 mg.
Setting
Clinical pharmacology research unit.
Participants
200 Volunteer smokers who smoked their first cigarette of the day within 30 min of waking.
Interventions
Subjects abstained from smoking the night before the morning they attended the laboratory. Treatment was administered following 5 h of witnessed abstinence.
Primary and secondary outcome measures
Urge to smoke was rated before and at 1, 3, 5, 10, 15, 25, 30, 45 min and 1, 1.5, and 2 h after treatment administration. The primary outcome concerned change during the first 1, 3 and 5 min after treatment administration.
Results
Nicotine mouth spray achieved greater reductions in craving than either lozenge during the first 1, 3 and 5 min postadministration. After using mouth spray, half of the users experienced 50% reduction in craving within 3.40 min, while the same treatment effect was achieved within 9.92 and 9.20 min for the 2 and 4 mg lozenge, respectively. Adverse events with both mouth spray and lozenge were mostly mild. Hiccups, local irritation, nausea and dyspepsia were more frequent with spray than lozenge.
Conclusions
Nicotine mouth spray provides a faster relief of cravings than nicotine lozenge.
Articles from BMJ Open are provided here courtesy of
BMJ Group