Profile
International Journal of Clinical Research & Trials Volume 5 (2020), Article ID 5:IJCRT-141, 8 pages
https://doi.org/10.15344/2456-8007/2020/141
Research Article
Method for Estimating Non-study Cigarette Use among Switchers to Low Nicotine Content Cigarettes in Ambulatory Clinical Studies

Mingda Zhang*, Jeffery Edmiston, George Karles, and Donna Smith

Altria Client Services LLC, 601 E. Jackson Street, Richmond, VA 23219, USA
Dr. Mingda Zhang, Altria Client Services LLC, 601 E. Jackson Street, Richmond, VA 23219, USA, Tel: +1-804-335-2011; E-mail: mingda.zhang@altria.com
20 December 2019; 18 January 2020; 20 January 2020
Zhang M, Edmiston J, Karles G, Smith D (2019) Method for Estimating Non-study Cigarette Use among Switchers to Low Nicotine Content Cigarettes in Ambulatory Clinical Studies. Int J Clin Res Trials 5: 141. doi: https://doi.org/10.15344/2456-8007/2020/141
This work was funded internally by Altria Client Services LLC.

References

  1. US Food and Drug Administration (2018) Tobacco product standard for nicotine level of combusted cigarettes. [View]
  2. Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, et al. (2015) Randomized trial of reduced-nicotine standards for cigarettes. N Engl J Med 373: 1340-1349. [CrossRef] [Google Scholar] [PubMed]
  3. Benowitz NL, Nardone N, Hatsukami DK, Donny EC (2015) Biochemical estimation of noncompliance with smoking of very low nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev 24: 331-335. [CrossRef] [Google Scholar] [PubMed]
  4. Nardone N, Donny EC, Hatsukami DK, Koopmeiners JS, Murphy SE, et al. (2016) Estimations and predictors of non-compliance in switchers to reduced nicotine content cigarettes. Addiction 111: 2208-2216. [CrossRef] [Google Scholar] [PubMed]
  5. Goldstein JA, Goldstein LK (2016) Randomized trial of reduced-nicotine standards for cigarettes. N Engl J Med 374: 395-396. [CrossRef] [PubMed]
  6. Foulds J, Hobkirk A, Wasserman E, Richie J, Veldheer S, et al. (2018) Estimation of compliance with exclusive smoking of very low nicotine content cigarettes using plasma cotinine. Prev Med 117: 24-29. [CrossRef] [Google Scholar] [PubMed]
  7. Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK (2015) Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control 24: 536-539. [CrossRef] [Google Scholar] [PubMed]
  8. Hatsukami DK, Donny EC, Koopmeiners JS, Benowitz NL (2015) Compensatory smoking from gradual and immediate reduction in cigarette nicotine content. Cancer Epidemiol Biomarkers Prev 24: 472-476. [CrossRef] [Google Scholar] [PubMed]
  9. Hammond D, O'Connor RJ (2014) Reduced nicotine cigarettes: Smoking behavior and biomarkers of exposure among smokers not intending to quit. Cancer Epidemiol Biomarkers Prev 23: 2032-2040. [CrossRef] [Google Scholar] [PubMed]
  10. Mercincavage M, Souprountchouk V, Tang KZ, Dumont RL, Wileyto EP, et al. (2016) A randomized controlled trial of progressively reduced nicotine content cigarettes on smoking behaviors, biomarkers of exposure, and subjective ratings. Cancer Epidemiol Biomarkers Prev 25: 1125-1133. [CrossRef] [Google Scholar] [PubMed]
  11. Hatsukami DK, Luo X, Jensen JA, al'Absi M, Allen SS, et al. (2018) Effect of immediate vs gradual reduction in nicotine content of cigarettes on biomarkers of smoke exposure: A randomized clinical trial. Jama 320: 880-891. [CrossRef] [Google Scholar] [PubMed]
  12. Denlinger RL, Smith TT, Murphy SE, Koopmeiners JS, Benowitz NL, et al. (2016) Nicotine and anatabine exposure from very low nicotine content cigarettes. Tob Regul Sci 2: 186-203. [CrossRef] [Google Scholar] [PubMed]
  13. National Institute on Drug Abuse (2018) Nicotine research cigarettes drug supply program. [View]
  14. Cassidy RN, Colby SM, Tidey JW, Jackson KM, Cioe PA, et al. (2018) Adolescent smokers' response to reducing the nicotine content of cigarettes: Acute effects on withdrawal symptoms and subjective evaluations. Drug Alcohol Depend 188: 153-160. [CrossRef] [Google Scholar] [PubMed]
  15. Faulkner P, Ghahremani DG, Tyndale RF, Cox CM, Kazanjian AS, et al. (2017) Reduced-nicotine cigarettes in young smokers: Impact of nicotine metabolism on nicotine dose effects. Neuropsychopharmacology 42: 1610-1618. [CrossRef] [Google Scholar] [PubMed]
  16. Higgins ST, Heil SH, Sigmon SC, Tidey JW, Gaalema DE, et al. (2017) Addiction potential of cigarettes with reduced nicotine content in populations with psychiatric disorders and other vulnerabilities to tobacco addiction. JAMA Psychiatry 74: 1056-1064. [CrossRef] [Google Scholar] [PubMed]
  17. Perkins KA, Kunkle N, Karelitz JL (2017) Threshold dose for behavioral discrimination of cigarette nicotine content in menthol vs. Non-menthol smokers. Psychopharmacology (Berl) 234: 1255-1265. [CrossRef] [Google Scholar] [PubMed]
  18. Perkins KA, Kunkle N, Karelitz JL, Michael VC, Donny EC, et al. (2016) Threshold dose for discrimination of nicotine via cigarette smoking. Psychopharmacology (Berl) 233: 2309-2317. [CrossRef] [Google Scholar] [PubMed]
  19. Shiffman S, Kurland BF, Scholl SM, Mao JM (2018) Nondaily smokers' changes in cigarette consumption with very low-nicotine-content cigarettes: A randomized double-blind clinical trial. JAMA Psychiatry 75: 995-1002. [CrossRef] [Google Scholar] [PubMed]
  20. Jarvis MJ, Russell MA, Benowitz NL, Feyerabend C (1988) Elimination of cotinine from body fluids: Implications for noninvasive measurement of tobacco smoke exposure. Am J Public Health 78: 696-698. [CrossRef] [Google Scholar] [PubMed]
  21. Benowitz NL, Jacob P 3rd (1994) Metabolism of nicotine to cotinine studied by a dual stable isotope method. Clin Pharmacol Ther 56: 483-493. [CrossRef] [Google Scholar] [PubMed]
  22. Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, et al. (2007) Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev 16: 2479-2485. [CrossRef] [Google Scholar] [PubMed]
  23. Mercincavage M, Smyth JM, Strasser AA, Branstetter SA (2016) Reduced nicotine content expectancies affect initial responses to smoking. Tob Regul Sci 2: 309-316. [CrossRef] [Google Scholar] [PubMed]
  24. Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, et al. (2015) Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction 110: 1667-1675. [CrossRef] [Google Scholar] [PubMed]
  25. Ding YS, Richter P, Hearn B, Zhang L, Bravo R, et al. (2017) Chemical characterization of mainstream smoke from spectrum variable nicotine research cigarettes. Tob Regul Sci 3: 81-94. [CrossRef] [Google Scholar] [PubMed]
  26. Richter P, Steven PR, Bravo R, Lisko JG, Damian M, et al. (2016) Characterization of spectrum variable nicotine research cigarettes. Tob Regul Sci 2: 94-105. [CrossRef] [Google Scholar] [PubMed]
  27. Mendes P, Liang Q, Frost-Pineda K, Munjal S, Walk RA, et al. (2009) The relationship between smoking machine derived tar yields and biomarkers of exposure in adult cigarette smokers in the us. Regul Toxicol Pharmacol 55: 17-27. [CrossRef] [Google Scholar] [PubMed]
  28. Theophilus EH, Coggins CR, Chen P, Schmidt E, Borgerding MF, et al. (2015) Magnitudes of biomarker reductions in response to controlled reductions in cigarettes smoked per day: A one-week clinical confinement study. Regul Toxicol Pharmacol 71: 225-234. [CrossRef] [Google Scholar] [PubMed]
  29. Jarvis MJ, Foulds J, Feyerabend C (1992) Exposure to passive smoking among bar staff. Br J Addict 87: 111-113. [CrossRef] [Google Scholar]
  30. Roethig HJ, Munjal S, Feng S, Liang Q, Sarkar M, et al. (2009) Population estimates for biomarkers of exposure to cigarette smoke in adult u.S. Cigarette smokers. Nicotine Tob Res 11: 1216-1225. [CrossRef] [Google Scholar] [PubMed]
  31. Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, et al. (2016) Reduced nicotine content cigarettes and use of alternative nicotine products: Exploratory trial. Addiction 112: 156-167. [CrossRef] [Google Scholar] [PubMed]