Nicotine Substitute Prescribed at Hourly Intake or ad Libitum for Heavy Smokers Willing to Quit
Status:
Completed
Trial end date:
2001-12-01
Target enrollment:
Participant gender:
Summary
Objective: To assess the impact of instructional guidance in the regular use of use nicotine
nasal spray (NNS) on the true use of NNS during the first three weeks of smoking cessation
for heavy smokers who are willing to quit.
Methods: This randomized, open, controlled trial included 50 patients who were heavy smokers,
were willing to quit, and attending an academic outpatient clinic in Western Switzerland.
Patients were randomised to instruction on NNS use as "ad libitum" (administration whenever
cravings appear; control group) or to use NNS at least every hour when awake (intervention
group). Intakes were monitored using an electronic device fixed in the spray unit (MDILogTM)
during the first three weeks of use. Self reported abstinence from smoking at six months was
confirmed by expired-air carbon monoxide. Using intention-to-treat analysis, random-effect
GLS regression was used to calculate the mean difference of daily doses between groups
controlling for lack of independence between measures from the same individual.