Abstract
ObjectiveTo 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.MethodsThis 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 when craving appears and at least every hour when awake (intervention group). Intakes were monitored using an electronic device fixed in the spray unit (MDILog™) 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.ResultsOne patient was lost to follow-up. At baseline randomization, the group receiving instruction to use NNS hourly included more women, patients with previous desires to quit, and patients with more psychiatric comorbidities and less somatic complaints compared to the group instructed to use NNS with cravings (group imbalance). Both groups self-administered more than the daily recommended dosage of 8 uses. Mean daily usage was 13.6 dose/day and 11.1 dose/day for the group instructed to use NNS hourly and with cravings, respectively. Adjusting for baseline imbalance, the increased daily doses in the intervention group (hourly use) remained nonsignificant compared to ad libitum use (-0.5 dose/day; CI 95% -6.2; 5.3, from day 1 to day 7; and 2.3 dose/day; CI 95% -5.4; 10.0, from day 8 to day 21). Instructing patients to use the NNS daily had no effect on smoking cessation at six months (RR = 0.69; CI 95% 0.34; 1.39).ConclusionHeavy smokers willing to quit use NNS frequently, regardless of the instructions given. Recommending the use of NNS only when craving appears for heavy smokers willing to quit seems acceptable compared to prescribing hourly administration.Trial registration-ClinicalTrials.gov: NCT00861276
Highlights
Cigarette smoking is currently the greatest preventable cause of death in our society; smoking cessation is regarded as one of the important preventive practices in modern medicine [1]
The aim of our study is to assess the effect of instructions for regular use of Nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of attempted quitting; a secondary aim is to assess the effect of instruction for regular NNS use on smoking cessation success rates at 6 months compared with the currently recommended "ad libitum" use
Control In the control group, participants were instructed to use NNS as needed to suppress withdrawal symptoms when cravings appeared. Participants This open, randomized, controlled study was conducted in a group of 50 highly dependent smokers seen in the Department of Ambulatory care and Community Medicine in Lausanne, Switzerland
Summary
Cigarette smoking is currently the greatest preventable cause of death in our society; smoking cessation is regarded as one of the important preventive practices in modern medicine [1]. Nicotine nasal spray (NNS) was developed to allow rapid delivery of nicotine through the nasal mucosa, allowing more rapid absorption than with the nicotine patch or gum. This rapid absorption and the user's ability to control the rate of use with NNS allow subjects to adjust the dose as needed. This type of nicotine substitution is suitable for highly dependent smokers [5], willing to quit but with acute episodes of craving [6]. Prescribing regularly scheduled use of NNS rather than instructing the patient to use the spray only when desired may improve the number of successful quitters. The aim of our study is to assess the effect of instructions for regular use of NNS on the true use of NNS during the first three weeks of attempted quitting; a secondary aim is to assess the effect of instruction for regular NNS use on smoking cessation success rates at 6 months compared with the currently recommended "ad libitum" use
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