Nasal Nicotine Solution as an Aid to Cigarette Withdrawal: a pilot clinical trial (original) (raw)
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A double-blind randomized trial of nicotine nasal spray as an aid in smoking cessation
European Respiratory Journal, 1997
The objective of the study was to evaluate the therapeutic efficacy of nicotine nasal solution (NNS) for smoking cessation from the stopping day up to 3 months. We also followed the participants for 2 yrs after ceasing smoking to assess what happens after stopping using NNS. In a placebo-controlled, double-blind, 2 yr prospective study, 157 smokers were given either NNS, one dose containing 1 mg of nicotine per 100 µL (n=79), or placebo (n=78). Treatment was continued for up to 1 yr. One day after quitting smoking, the average number of daily doses was 11 in the group assigned NNS and 14 in the group assigned the placebo, and after 6 weeks, 14 and 6 doses, respectively, among abstinent participants still using spray. After 3 months, 65% of the abstainers in the nicotine group were still using the NNS. The abstinence rates were 51, 39 and 29% after 6 weeks, 3 and 6 months, respectively, as compared to 24, 19 and 18% in the placebo group (p=0.0003; p=0.003; p=0.050). The proportion abstinent at the 1 yr (25 vs 17%) and 2 yr follow-ups (19 vs 14%) was higher among those assigned to the nicotine than to the placebo group, but not significantly so for the numbers used in the study. In conclusion, the use of nicotine nasal spray significantly increased the abstinence rate during the first 6 months following the quitting day.
BMJ, 1999
Objective To evaluate the efficacy of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year. Design Placebo controlled, double blind trial. Setting Reykjavik health centre. Subjects 237 smokers aged 22-66 years living in or around Reykjavik. Interventions Nicotine patch for 5 months with nicotine nasal spray for 1 year (n = 118) or nicotine patch with placebo spray (n = 119). Treatment with patches included 15 mg of nicotine for 3 months, 10 mg for the fourth month, and 5 mg for the fifth month, whereas nicotine in the nasal spray was available for up to 1 year. Both groups received supportive treatment. Main outcome measure Sustained abstinence from smoking. Results The log rank test for 6 years (2 = 8.5, P = 0.004) shows a significant association between abstinence from smoking and type of treatment. Sustained abstinence rates for the patch and nasal spray group and patch only group were 51% v 35% after 6 weeks (P = 0.011 (2), 95% confidence interval 1.17% to 3.32%), 37% v 25% after 3 months (P = 0.045, 1.01% to 3.08%), 31% v 16% after 6 months (P = 0.005, 1.27% to 4.50%), 27% v 11% after 12 months (P = 0.001, 1.50% to 6.14%), and 16% v 9% after 6 years (P = 0.077, 0.93% to 4.72%). Conclusions Short and long term abstinence rates show that the combination of using a nicotine patch for 5 months with a nicotine nasal spray for 1 year is a more effective method of stopping smoking than using a patch only. The low percentage of participants using the nasal spray at 1 year, and the few relapses during the second year, suggest that it is not cost effective to use a nasal spray for longer than 7 months after stopping a patch.
Randomised controlled trial of nasal nicotine spray in smoking cessation
The Lancet, 1992
Studies with nicotine chewing gum and nicotine skin patches indicate that nicotine replacement can help people to give up smoking. The rapidity with which nicotine is absorbed when given as a nasal spray suggests that it might be effective for those for whom the other means of replacement are too slow.
Addiction, 2011
Of six established nicotine replacement therapy (NRT) formulations, only the gum and patch have been tested without specialist clinic support in placebo-controlled trials. We aimed to broaden the evidence base by examining if the nicotine nasal spray (NNS) could be effective with only brief support in general practice. Design Randomized placebo-controlled trial. Setting Twenty-seven English general practices. Participants A total of 761 heavy smokers received brief support and 12 weeks of treatment with NNS (506) or placebo (255). Measurements The primary outcome was biochemically verified complete abstinence from smoking throughout weeks 3-12. Findings NNS compared with placebo more than doubled the number who successfully stopped smoking [15.4% versus 6.7%, odds ratio (OR) = 2.6, 95% confidence interval (CI) = 1.5-4.4]. Many participants reported minor irritant adverse symptoms. NNS was particularly effective among those who were more highly dependent on nicotine (OR = 6.17, 95% CI = 2.13-17.9). Of those who failed to stop during the first week (417, 54.8%), only one (0.2%) achieved later success. Conclusions NNS is effective when given in primary care. The benefit was lower than in a specialist clinic but similar to that with the nicotine patch in primary care. Unlike most other NRT formulations, bupropion or varenicline, NNS was especially helpful for more dependent smokers. Continuing treatment of those initially failing was not beneficial. An initial 1-week prescription to those more dependent on nicotine is likely to be the most cost-effective NNS treatment protocol. These results should offer support to the effectiveness of the other NRT formulations untested in this setting.
Nasal spray nicotine replacement suppresses cigarette smoking desire and behavior
Clinical pharmacology and therapeutics, 1992
The effects of short-term nasal spray nicotine replacement in suppressing desire to smoke and ad libitum cigarette smoking behavior were evaluated in male and female smokers. In study I, 10 male and 10 female smokers received intermittent doses of 0, 7.5, 15, and 30 micrograms/kg nicotine by way of measured-dose nasal spray, with each dose on a separate day. Self-reported desire to smoke was significantly suppressed by each nicotine dose compared with placebo, but there were no significant differences among nicotine doses or between men and women. In study II, eight male and eight female smokers received 0, 15, and 30 micrograms/kg nicotine intermittently and were allowed to smoke their preferred brands of cigarettes ad libitum. Similar to study I, nicotine replacement significantly suppressed number of cigarettes smoked, number of puffs, and carbon monoxide boost and increased latency to smoking, but there were almost no significant differences between the two nicotine doses. Magni...
Recycling of hard-core smokers with nicotine nasal spray
European Respiratory Journal, 1996
The primary aim of this smoking cessation study was to evaluate the effect of long-term treatment with nicotine nasal spray in a group of hard-core smokers. A further aim was to compare the effect of ad libitum with fixed dosage of nasal nicotine spray.
Plasma Nicotine Concentrations from Repeated Doses of Nasal Nicotine Solution
Addiction, 1984
A nasal nicotine solution (NNS) has been proposed as a potential cessation aid for cigarette smokers , the principle being similar to that underlying use of nicotine chewing gum, i.e. nicotine replacement following cessation to ease withdrawal symptoms. We conducted a study to determine the plasma nicotine concentrations resulting from eight, hourly administrations of 2 mg NNS. The peak plasma nicotine concentrations rose to an average of 16.3 ng/ml, which is higher than is normally obtained from 2 mg nicotine chewing gum. There was considerable variability in levels obtained from the NNS, with one subject obtaining levels similar to those found in heavy cigarette smokers. The initial doses produced noticeable light headedness in four of the five subjects. Nasal nicotine solution could provide more effective nicotine replacement than nicotine gum.
Nasal nicotine spray: a rapid nicotine delivery system
Psychopharmacology, 1992
Plasma nicotine concentrations following administration by two types of nasal nicotine spray were compared in ten subjects. Absorption was particularly rapid during the first 2.5 rain, the average rise in blood nicotine concentrations during this time being 8.6 ng/ml for the two products, followed by a small further rise to an average peak increase of 10.5 ng/ml 5 rain after the dose of 2 mg nicotine base (mean 27.8 pg/kg). Despite a four-fold Cm~x variation between subjects, the levels of individual subjects were fairly consistent across the two products. There were no significant differences between the two products in blood nicotine concentrations or cardiovascular responses, and the correlation between the AUCs from the two products was 0.68 (P=0.01). Eight subjects reported subjective feelings of lightheadedness or slight dizziness, which are not typical after slower absorption from nicotine gum or skin patches. Blood nicotine levels within the smoking range were soon built up with repeated doses, even in the subject with the least efficient nasal absorption. In a second study of ad libitum use under clinical conditions both products appeared sufficiently acceptable for therapeutic use as an aid to smoking cessation. There was no tendency to escalate to excessive use over 4 weeks, and blood nicotine concentrations in nine subjects averaged only 44% of their prior smoking levels. Only one subject had levels equivalent to prior smoking and possible reasons why this was not more common are discussed.
Nicotine & Tobacco Research, 2003
This multicenter, randomized, open-label clinical trial was conducted to determine whether the combined use of nicotine patch therapy and a nicotine nasal spray would improve smoking abstinence rates compared to either treatment alone, without behavioral counseling. Data were collected at 15 regional cancer control oncology centers within the North Central Cancer Treatment Group. Of the 1384 smokers randomized to the study, 20% were abstinent from smoking at 6 weeks and 8% were abstinent at 6 months. At 6 weeks, the 7-day point prevalence smoking abstinence rate for the patch alone (21.1%) was superior to the spray (13.6%) but was significantly lower than the rate for combination therapy (27.1%). At 6 months, the 7-day point prevalence abstinence rates were not significantly different among the three groups. Combination nicotine nasal spray and nicotine patches were delivered safely in a nonspecialized outpatient clinical setting and enhanced short-term smoking abstinence rates, but these rates were not sustained at 6 months.
Subjective effects of an initial dose of nicotine nasal spray predict treatment outcome
Psychopharmacology, 2004
Rationale: Nicotine nasal spray (NS) is recommended as one of five first-line smoking cessation products. A clinically convenient tool to identify smokers most likely to benefit from NS could assist healthcare practitioners in selecting the optimal treatment for individual patients. Objectives: To evaluate whether the subjective effects of an initial pre-treatment dose of NS predict 6 month abstinence rates following NS treatment for tobacco dependence. Methods: One hundred and seventy-five smokers received an initial 1 mg pretreatment dose of NS and completed a new measure of NS subjective effects (initial spray experience, ISE). This measure, together with demographic and smoking history variables, was examined as a predictor of 6-month pointprevalence (biochemically verified) abstinence rates. Results: Factor analysis revealed positive and negative effects subscales of the ISE. Smokers with higher ratings of positive effects from the pre-treatment NS dose were significantly more likely to be abstinent at 6-month follow-up. These effects were partially mediated by reduction in urge to smoke. Conclusions: Pending additional validation in human laboratory and clinical studies, assessment of the acute positive subjective effects of initial NS delivery may be an efficient way to predict who will be successful with NS treatment for tobacco dependence.