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Фармакодинамические эффекты никотинового спрея для ротовой полости и таблеток цитизина: исследование у взрослых здоровых курильщиков
McCaffrey V., Hansson A., Perfekt R. Фармакодинамические эффекты никотинового спрея для ротовой полости и таблеток цитизина: исследование у взрослых здоровых курильщиков. Consilium Medicum. 2019; 21 (11): 28–33. DOI: 10.26442/20751753.2019.11.190254
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McCaffrey V., Hansson A., Perfekt R. Pharmacodynamic effects of nicotine mouth spray and cytisine tablet. A study in adult healthy smokers. Consilium Medicum. 2019; 21 (11): 28–33. DOI: 10.26442/20751753.2019.11.190254
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Аннотация
Важнейшим аспектом для увеличения частоты успешных попыток бросить курить является ослабление тяги к сигаретам. Временное облегчение тяги к сигаретам является терапевтическим показанием к применению никотин-заместительной терапии, а доставка никотина путем распыления раствора в ротовой полости обеспечивает более быстрое наступление эффекта. Цитизин представляет собой растительный алкалоид, который также показан для лечения никотиновой зависимости. В этом открытом рандомизированном перекрестном исследовании с однократным введением препарата проводилось сравнение позывов к курению у 59 пациентов, воздерживающихся от употребления табака в течение 12 ч, после использования двух последовательных доз никотинового спрея для ротовой полости (1 мг никотина/распыление) или одной таблетки цитизина 1,5 мг в разные дни лечения, разделенные отмывочным периодом не менее 36 ч. Позывы к курению оценивали по визуальной аналоговой шкале. Результаты данного исследования показали, что после использования спрея для ротовой полости с никотином (2 дозы ¥ 1 мг) отмечается существенное и статистически значимое более быстрое ослабление позывов к курению по сравнению с таблетками цитизина 1,5 мг.
Ключевые слова: никотин-заместительная терапия, отказ от курения, позывы к курению, ослабление тяги.
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The relief of cigarette craving is crucial to increase the success rate of attempts to quit smoking. Temporary relief of cigarette cravings is the therapeutic indication of nicotine replacement therapy. Cytisine is a plant-based alkaloid that is specifically indicated in the management of nicotine dependence. The aim of this open-label, single-dose, randomized, crossover study was to compare the urge-to-smoke in 59 abstinent smokers, who followed an overnight 12-hour nicotine abstinence period, following two consecutive sprays of nicotine mouth spray 1 mg nicotine/spray or one 1.5 mg cytisine tablet on separate treatment days, separated by a washout period of at least 36 hours. Urges to smoke were scored on a visual analogue scale. The results of this study indicate that the onset of relief of urges to smoke following use of nicotine mouth spray 2¥1 mg is substantially and statistically significantly faster than that of cytisine tablet 1.5 mg.
Key words: nicotine replacement therapy, smoking cessation, urges to smoke, craving relief.
Key words: nicotine replacement therapy, smoking cessation, urges to smoke, craving relief.
Полный текст
Список литературы
1. Taggar JS, Lewis S, Docherty G et al. Do cravings predict smoking cessation in smokers calling a national quit line: secondary analyses from a randomised trial for the utility of “urges to smoke” measures. Subst Abuse Treat Prev Policy 2015; 10: 15.
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9. McCarthy DE, Piasecki TM, Lawrence DL et al. Psychological Mediators of Bupropion SR Treatment for Smoking Cessation. Addiction (Abingdon, England) 2008; 103 (9): 1521–33.
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14. Wadgave U, Nagesh L. Nicotine Replacement Therapy: An Overview. Int J Health Sci 2016; 10 (3): 425–35.
15. Garvey AJ, Kinnunen T, Nordstrom BL et al. Effects of nicotine gum dose by level of nicotine dependence. Nicotine Tob Res 2000; 2: 53–63.
16. Shiffman S. Use of more nicotine lozenges leads to better success in quitting smoking. Addiction 2007; 102: 809–14.
17. Tønnesen P, Paoletti P, Gustavsson G et al. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J 1999; 13 (2): 238–46.
18. Balmford J, Borland R, Hammond D, Cummings KM. Adherence to and reasons for premature discontinuation from stop-smoking medications: data from the ITC Four-Country Survey. Nic Tob Res 2011; 13: 94–102.
19. Hansson A, Hajek P, Perfekt R, Kraiczi H. Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial. BMJ Open 2012; 2: e001618.
20. Prochaska JJ, Das S, Benowitz NL. Cytisine, the world's oldest smoking cessation aid. BMJ 2013; 347: f5198.
21. Jeong SH, Newcombe D, Sheridan J, Tingle M. Pharmacokinetics of cytisine, an a4 b2 nicotinic receptor partial agonist, in healthy smokers following a single dose. Drug Test Anal 2015; 7 (6): 475–82.
22. Ravva P, Gastonguay MR, Faessel HM et al. Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers. Nicotine Tob Res 2015; 17 (1): 106–13.
23. Hansson A, Rasmussen T, Kraiczi H. Single-Dose and Multiple-Dose Pharmacokinetics of Nicotine 6 mg Gum. Nicotine Tob Res 2017; 19 (4): 477–83.
24. Shiffman S, Hickcox M, Paty JA et al. Progression from a smoking lapse to relapse: prediction from abstinence violation effects, nicotine dependence, and lapse characteristics. J Consult Clin
Psychol 1996; 64 (5): 993–1002.
________________________________________________
1. Taggar JS, Lewis S, Docherty G et al. Do cravings predict smoking cessation in smokers calling a national quit line: secondary analyses from a randomised trial for the utility of “urges to smoke” measures. Subst Abuse Treat Prev Policy 2015; 10: 15.
2. Piasecki T. Relapse to smoking. Clin Psychol Rev 2006; 26: 196–215.
3. Swan G, Ward MM, Jack LM. Abstinence effects as predictors of 28-day relapse in smokers. Addict Behav 1996; 21 (4): 481–90.
4. Shiffman S. Refining models of dependence: Variations across persons and situations. Br J Addict 1991; 86: 611–5.
5. Shiffman S, Hickcox M, Paty JA et al. Individual differences in the context of smoking lapse episodes. Addict Behav 1997; 22 (6): 797–811.
6. Fidler JA, West R. Enjoyment of smoking and urges to smoke as predictors of attempts and success of attempts to stop smoking: a longitudinal study. Drug Alcohol Depend 2011; 115 (1–2): 30–4.
7. Benowitz NL. Clinical pharmacology of nicotine: implications for understanding, preventing, and treating tobacco addiction. Clin Pharmacol Ther 2008; 83 (4): 531–41.
8. Piper ME, Federman EB, McCarthy DE et al. Using medication models to explore the nature of tobacco motivation and tobacco treatment effects. J Abnorm Psychol 2008; 117: 94–105.
9. McCarthy DE, Piasecki TM, Lawrence DL et al. Psychological Mediators of Bupropion SR Treatment for Smoking Cessation. Addiction (Abingdon, England) 2008; 103 (9): 1521–33.
10. Ferguson SG, Shiffman S, Gwaltney CJ. Does reducing withdrawal severity mediate nicotine patch efficacy? A randomized clinical trial. J Consult Clin Psychol 2006; 74 (6): 1153–61.
11. American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, D.C.: American Psychiatric Association, 2013; p. 571–7.
12. Hartmann-Boyce J, Chepkin SC, Ye W et al. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev 2018; 5: CD000146.
13. Etter J, Stapleton JA. Nicotine replacement therapy for long‐term smoking cessation: a meta‐analysis. Tobacco Control 2006; 15 (4): 280–5.
14. Wadgave U, Nagesh L. Nicotine Replacement Therapy: An Overview. Int J Health Sci 2016; 10 (3): 425–35.
15. Garvey AJ, Kinnunen T, Nordstrom BL et al. Effects of nicotine gum dose by level of nicotine dependence. Nicotine Tob Res 2000; 2: 53–63.
16. Shiffman S. Use of more nicotine lozenges leads to better success in quitting smoking. Addiction 2007; 102: 809–14.
17. Tønnesen P, Paoletti P, Gustavsson G et al. Higher dosage nicotine patches increase one-year smoking cessation rates: results from the European CEASE trial. Collaborative European Anti-Smoking Evaluation. European Respiratory Society. Eur Respir J 1999; 13 (2): 238–46.
18. Balmford J, Borland R, Hammond D, Cummings KM. Adherence to and reasons for premature discontinuation from stop-smoking medications: data from the ITC Four-Country Survey. Nic Tob Res 2011; 13: 94–102.
19. Hansson A, Hajek P, Perfekt R, Kraiczi H. Effects of nicotine mouth spray on urges to smoke, a randomised clinical trial. BMJ Open 2012; 2: e001618.
20. Prochaska JJ, Das S, Benowitz NL. Cytisine, the world's oldest smoking cessation aid. BMJ 2013; 347: f5198.
21. Jeong SH, Newcombe D, Sheridan J, Tingle M. Pharmacokinetics of cytisine, an a4 b2 nicotinic receptor partial agonist, in healthy smokers following a single dose. Drug Test Anal 2015; 7 (6): 475–82.
22. Ravva P, Gastonguay MR, Faessel HM et al. Pharmacokinetic-pharmacodynamic modeling of the effect of varenicline on nicotine craving in adult smokers. Nicotine Tob Res 2015; 17 (1): 106–13.
23. Hansson A, Rasmussen T, Kraiczi H. Single-Dose and Multiple-Dose Pharmacokinetics of Nicotine 6 mg Gum. Nicotine Tob Res 2017; 19 (4): 477–83.
24. Shiffman S, Hickcox M, Paty JA et al. Progression from a smoking lapse to relapse: prediction from abstinence violation effects, nicotine dependence, and lapse characteristics. J Consult Clin
Psychol 1996; 64 (5): 993–1002.
Авторы
McCaffrey Victoria – Медицинское подразделение, «Подразделение потребительских товаров Джонсон & Джонсон ЕМЕА»
Hansson Anna – Глобальная клиническая фармакология, «МакНейл АБ». E-mail: ahansson@its.jnj.com
Perfekt Roland – Количественные науки, «МакНейл АБ»________________________________________________
McCaffrey Victoria – Consumer Health Products Department, “Consumer Products Department Johnson & Johnson ЕМЕА”
Hansson Anna – Global Clinical Pharmacology, “McNeil AB”. E-mail: ahansson@its.jnj.com
Perfekt roland – Quantitative Sciences, “McNeil AB”
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