31
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

      Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial

      research-article

      Read this article at

      ScienceOpenPublisherPMC
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          A nicotine mouth spray has advantages over other acute forms of nicotine replacement therapy, such as a faster uptake of nicotine and faster relief of craving.

          This multicentre, randomised (2:1), double-blind, placebo-controlled efficacy and safety study evaluated self-reported, carbon monoxide-verified continuous abstinence from smoking from week 2 until weeks 6, 24, and 52 in 479 smokers (≥1 cigarette per day) who were treated with either active (n=318) or placebo (n=161) spray for 12 weeks and low-intensity counselling at three smoking cessation clinics in Denmark and Germany.

          Active treatment yielded significantly higher continuous abstinence rates than placebo from week 2 until week 6 (26.1% versus 16.1%; relative success rate (RR) 1.62, 95% CI 1.09–2.41), week 24 (15.7% versus 6.8%; RR 2.30, 95% CI 1.23–4.30), and week 52 (13.8% versus 5.6%; RR 2.48, 95% CI 1.24–4.94). Most adverse events were mild to moderate, and 9.1% of subjects on active spray withdrew due to adverse events, compared to 7.5% on placebo. The overall rate of treatment-related adverse events was 87.4% with active spray versus 71.4% with placebo spray.

          Nicotine mouth spray delivered significantly higher 6-, 24- and 52-week continuous abstinence rates than placebo.

          Related collections

          Most cited references14

          • Record: found
          • Abstract: found
          • Article: not found

          Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction.

          N Benowitz (2008)
          Understanding the basic and clinical pharmacology of nicotine provides a basis for improved prevention and treatment of tobacco addiction. Nicotine acts on nicotinic cholinergic receptors in the brain to release dopamine and other neurotransmitters that sustain addiction. Neuroadaptation and tolerance involve changes in both nicotinic receptors and neural plasticity. Nicotine addiction can occur in the context of physical dependence characterized by self-medication to modulate negative affect and/or to relieve withdrawal symptoms, as well as, in light or occasional smokers, primarily for positive reinforcement in specific situations. Nicotine is metabolized primarily by CYP2A6. Its clearance exhibits considerable individual variability that is determined by genetic, racial, and hormonal (sex) factors. Genetically slow metabolism of nicotine appears to be associated with a lower level of dependence. Nicotine dependence is highly heritable and appears to be influenced by genes coding for some nicotine receptor subtypes, some neurotransmitter genes, and genes involved in neural connectivity. Novel pharmacotherapies for nicotine dependence include partial agonists for nicotinic receptors and nicotine vaccines. Pharmacogenetic studies suggest various candidate genes and a nicotine metabolism phenotype that influence outcome. Human pharmacology studies of nicotine and smoking behavior also provide a basis for assessing the benefits and risks of long-term nicotine use for harm reduction and for a potential cigarette regulatory strategy that includes reducing nicotine content of cigarettes to nonaddictive levels.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Nicotine replacement therapy for smoking cessation.

            The aim of nicotine replacement therapy (NRT) is temporarily to replace much of the nicotine from cigarettes to reduce motivation to smoke and nicotine withdrawal symptoms, thus easing the transition from cigarette smoking to complete abstinence. The aims of this review were:To determine the effect of NRT compared to placebo in aiding smoking cessation, and to consider whether there is a difference in effect for the different forms of NRT (chewing gum, transdermal patches, nasal spray, inhalers and tablets/lozenges) in achieving abstinence from cigarettes. To determine whether the effect is influenced by the dosage, form and timing of use of NRT; the intensity of additional advice and support offered to the smoker; or the clinical setting in which the smoker is recruited and treated. To determine whether combinations of NRT are more likely to lead to successful quitting than one type alone. To determine whether NRT is more or less likely to lead to successful quitting compared to other pharmacotherapies. We searched the Cochrane Tobacco Addiction Group trials register for papers with 'nicotine' or 'NRT' in the title, abstract or keywords. Date of most recent search July 2007. Randomized trials in which NRT was compared to placebo or to no treatment, or where different doses of NRT were compared. We excluded trials which did not report cessation rates, and those with follow up of less than six months. We extracted data in duplicate on the type of participants, the dose, duration and form of nicotine therapy, the outcome measures, method of randomization, and completeness of follow up. The main outcome measure was abstinence from smoking after at least six months of follow up. We used the most rigorous definition of abstinence for each trial, and biochemically validated rates if available. We calculated the risk ratio (RR) for each study. Where appropriate, we performed meta-analysis using a Mantel-Haenszel fixed-effect model. We identified 132 trials; 111 with over 40,000 participants contributed to the primary comparison between any type of NRT and a placebo or non-NRT control group. The RR of abstinence for any form of NRT relative to control was 1.58 (95% confidence interval [CI]: 1.50 to 1.66). The pooled RR for each type were 1.43 (95% CI: 1.33 to 1.53, 53 trials) for nicotine gum; 1.66 (95% CI: 1.53 to 1.81, 41 trials) for nicotine patch; 1.90 (95% CI: 1.36 to 2.67, 4 trials) for nicotine inhaler; 2.00 (95% CI: 1.63 to 2.45, 6 trials) for oral tablets/lozenges; and 2.02 (95% CI: 1.49 to 3.73, 4 trials) for nicotine nasal spray. The effects were largely independent of the duration of therapy, the intensity of additional support provided or the setting in which the NRT was offered. The effect was similar in a small group of studies that aimed to assess use of NRT obtained without a prescription. In highly dependent smokers there was a significant benefit of 4 mg gum compared with 2 mg gum, but weaker evidence of a benefit from higher doses of patch. There was evidence that combining a nicotine patch with a rapid delivery form of NRT was more effective than a single type of NRT. Only one study directly compared NRT to another pharmacotherapy. In this study quit rates with nicotine patch were lower than with the antidepressant bupropion. All of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) can help people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting by 50-70%, regardless of setting. The effectiveness of NRT appears to be largely independent of the intensity of additional support provided to the individual. Provision of more intense levels of support, although beneficial in facilitating the likelihood of quitting, is not essential to the success of NRT.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Craving is associated with smoking relapse: findings from three prospective studies.

              In a combined sample of more than 2600 smokers, immediate postcessation craving is shown to be prospectively associated with smokers' ability to maintain abstinence. Relapse is strikingly rapid among those reporting high levels of craving following cessation. More than 32% of those with high craving scores relapsed within 1 week of cessation. In contrast, fewer than 15% of those with low craving relapsed in the first week (p < .001). Our findings provide a warrant for an increased research effort designed to provide a better understanding of the factors that control following smoking cessation and the processes by which craving influences smoking relapse.
                Bookmark

                Author and article information

                Journal
                Eur Respir J
                Eur. Respir. J
                erj
                The European Respiratory Journal
                European Respiratory Society (442 Glossop Road, Sheffield, S10 2PX, UK )
                0903-1936
                1399-3003
                September 2012
                09 February 2012
                : 40
                : 3
                : 548-554
                Affiliations
                [* ]simpleDept of Pulmonary Medicine, Gentofte University Hospital , Copenhagen, Denmark
                [# ]simpleGlobal Medical Affairs and Clinical Research , McNeil AB, Helsingborg, Sweden
                []simpleDept of Addictive Behaviour and Addiction Medicine, Central Institute of Mental Health, University of Heidelberg
                [+ ]simpleDept of Psychiatry and Psychotherapy, Section for Addiction Medicine and Research, University Hospital of Tübingen , Germany
                [§ ]simpleBoth authors contributed equally
                Author notes
                P. Tønnesen, Dept of Pulmonary Medicine, Gentofte University Hospital, DK-2900 Hellerup, Denmark. E-mail: philipt@ 123456dadlnet.dk
                Article
                erj01558-2011
                10.1183/09031936.00155811
                3432241
                22323576
                3b7ed721-abf2-4bb3-9c1b-758834e9b923
                ©ERS 2012

                ERJ Open articles are open access and distributed under the terms of the ( Creative Commons Attribution Licence 3.0>)

                History
                : 08 September 2011
                : 11 January 2012
                Categories
                Original Article
                Smoke-related Disorders
                1

                Respiratory medicine
                intention-to-treat,placebo-controlled,nicotine replacement therapy,low-intensity counselling,continuous abstinence

                Comments

                Comment on this article