Abstract

Objective: This study aimed to retrospectively evaluate real-life data from patients using nicotine oral spray (NOS) for smoking cessation, focusing on sociodemographic characteristics, treatment adherence, side-effect profile, spray-use patterns, and early cessation outcomes.

Methods: In this single-center retrospective study, the records of 110 patients prescribed NOS were reviewed; 72 patients who initiated treatment and attended follow-up were included in the analysis. Sociodemographic characteristics, Fagerström Test for Nicotine Dependence scores, smoking behaviors, spray-use amounts, and 3-month treatment outcomes were assessed.

Results: The mean age of the study population was 42.18±12.70 years, and 48.6% were female. Early cessation, failure, and relapse rates were 38.9%, 38.9%, and 22.2%, respectively. The overall side-effect rate was 26.3%, with the most common adverse events being throat irritation (35.3%), nausea (23.5%), and retrosternal burning (17.6%). A strong association was observed between side-effect occurrence and relapse (p=0.005), and 41.7% of those who discontinued treatment reported side effects (p=0.045). Education level was significantly associated with cessation success (p=0.039). Spray-use amount correlated with craving frequency (r=0.65, p<0.001) and daily cigarette consumption (r=0.42, p=0.004), but was not associated with cessation outcome.

Conclusion: NOS is effective in controlling smoking urges but does not independently determine cessation success. Side-effect development increases relapse risk, highlighting the importance of early side-effect management and correct usage training. These findings provide real-world evidence regarding the clinical role of NOS in smoking cessation.

Keywords: smoking, nicotine dependence, nicotine replacement therapy, nicotine oral spray

References

  1. World Health Organization (WHO). Tobacco. 2025. Avaible at: https://www.who.int/news-room/fact-sheets/detail/tobacco (Accessed on Nov 6, 2025).
  2. Wittenberg RE, Wolfman SL, De Biasi M, Dani JA. Nicotinic acetylcholine receptors and nicotine addiction: a brief introduction. Neuropharmacology 2020; 177: 108256. https://doi.org/10.1016/j.neuropharm.2020.108256
  3. Hersi M, Beck A, Hamel C, et al. Effectiveness of smoking cessation interventions among adults: an overview of systematic reviews. Syst Rev 2024; 13: 179. https://doi.org/10.1186/s13643-024-02570-9
  4. Theodoulou A, Chepkin SC, Ye W, et al. Different doses, durations and modes of delivery of nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev 2023; 6: CD013308. https://doi.org/10.1002/14651858.CD013308.pub2
  5. Kraiczi H, Hansson A, Perfekt R. Single-dose pharmacokinetics of nicotine when given with a novel mouth spray for nicotine replacement therapy. Nicotine Tob Res 2011; 13: 1176-1182. https://doi.org/10.1093/ntr/ntr139
  6. Caldwell BO, Adamson SJ, Crane J. Combination rapid-acting nicotine mouth spray and nicotine patch therapy in smoking cessation. Nicotine Tob Res 2014; 16: 1356-1364. https://doi.org/10.1093/ntr/ntu084
  7. 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. https://doi.org/10.1136/bmjopen-2012-001618
  8. Atilla Uysal M, Kadakal F, Karşidağ Ç, et al. Fagerstrom test for nicotine dependence: reliability in a Turkish sample and factor analysis. Tüberküloz ve Toraks Derg. 2004;52(2):115-121.
  9. Nikitabs Kısa Ürün Bilgisi. 2025 Avaible at: https://www.nobel.com.tr/cmsfiles/turkey/products/nikitabs-1-5-mg-film-kapli-tablet-short-product-info-1.pdf?v=42 (Accessed on Mar 05, 2026).
  10. Danielsson T, Bennet H, McColgan B, Wang J. Effect of nicotine mouth spray on urges to vape: A randomized, placebo-controlled, pharmacodynamic clinical trial in exclusive e-cigarette users. Addiction 2025; 120: 95-105. https://doi.org/10.1111/add.16669
  11. Tonnesen P, Lauri H, Perfekt R, Batra A, Mann K. Efficacy and safety of a novel nicotine mouth spray in smoking cessation: a randomized, placebo-controlled, double blind, multicenter study with 52-week follow up. Eur Respir J. 2014;38(55):194. https://doi.org/10.1183/13993003/erj.38.Suppl_55.194
  12. Bolliger CT, van Biljon X, Axelsson A. A nicotine mouth spray for smoking cessation: a pilot study of preference, safety and efficacy. Respiration 2007; 74: 196-201. https://doi.org/10.1159/000097136
  13. Tønnesen P, Lauri H, Perfekt R, Mann K, Batra A. Efficacy of a nicotine mouth spray in smoking cessation: a randomised, double-blind trial. Eur Respir J 2012; 40: 548-554. https://doi.org/10.1183/09031936.00155811
  14. Rungraungrayabkul D, Gaewkhiew P, Vichayanrat T, Shrestha B, Buajeeb W. What is the impact of nicotine pouches on oral health: a systematic review. BMC Oral Health 2024; 24: 889. https://doi.org/10.1186/s12903-024-04598-8
  15. La Rosa GRM, Del Giovane C, Pedullà E, et al. Oral health effects of non-combustible nicotine products: protocol for a systematic review and network meta-analysis. Syst Rev 2025; 14: 90. https://doi.org/10.1186/s13643-025-02839-7
  16. Nides M, Danielsson T, Saunders F, et al. Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: a randomized, multicenter, controlled study in a naturalistic setting. Nicotine Tob Res 2020; 22: 339-345. https://doi.org/10.1093/ntr/nty246
  17. Burns EK, Levinson AH. Discontinuation of nicotine replacement therapy among smoking-cessation attempters. Am J Prev Med 2008; 34: 212-215. https://doi.org/10.1016/j.amepre.2007.11.010
  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. Nicotine Tob Res 2011; 13: 94-102. https://doi.org/10.1093/ntr/ntq215
  19. Sivaramakrishnan G, Alsobaiei M, Sridharan K. Oral side effects of locally delivered nicotine replacement therapy: a meta-analysis of randomized controlled trials. Int J Dent Hyg 2023; 21: 3-17. https://doi.org/10.1111/idh.12594
  20. Ermawan Effendi D, Ardani I, Handayani S, et al. Factors associated with quitting smoking among males: findings from Indonesian national health survey. Clin Epidemiol Glob Heal. 2024;28. https://doi.org/10.1016/j.cegh.2024.101672
  21. Alyousefi NA, Alquraini RS, Alyahya LF, Bin Hamad NM, Aljuribah DK, Aldossari KK. factors associated with successful smoking cessation among adults in saudi arabia-a cross-sectional study. Healthcare (Basel) 2025; 13: 1813. https://doi.org/10.3390/healthcare13151813
  22. Esmer B, Sengezer T, Aksu F, Özkara A, Aksu K. Clinical, sociodemographic and tobacco-use factors associated with smoking cessation rates at three years follow-up, Ankara, Turkey. Tob Prev Cessat 2019; 5: 47. https://doi.org/10.18332/tpc/114082
  23. Drumond Muzi C, Carvalho Figueiredo V, Raggio Luiz R. Health perception, health conditions, and smoking cessation in Brazil. Cad saúde colet. 2021;29. https://doi.org/10.1590/1414-462x202199010432

Copyright and license

Copyright © 2026 The Author(s). This is an open access article distributed under the Creative Commons Attribution License (CC BY), which permits unrestricted use, distribution, and reproduction in any medium or format, provided the original work is properly cited.

How to cite

Gökseven Arda, Y., & Zeren Öztürk, G. (2026). Evaluation of patients receiving nicotine oral spray treatment for smoking cessation: A retrospective analysis. Turkish Journal of Tobacco Control, 6(2), 78-86. https://doi.org/10.64511/TJTC.2026.43