Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial

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.