Assessment of the abuse liability of three menthol Vuse Solo electronic cigarettes relative to combustible cigarettes and nicotine gum

Psychopharmacology

Volumn 235, Issue 7, 2018, Pages 2077-2086

  Stiles, Mitchell F ^a   Campbell, Leanne R ^a   Jin, Tao ^a   Graff, Donald W ^b   Fant, Reginald V ^c   Henningfield, Jack E ^c  

^a RAI Services Company   (United States)

^b CELERION   (United States)

^c PINNEY ASSOCIATES   (United States)

Author keywords

Abuse liability; Electronic cigarettes; Menthol; Nicotine pharmacokinetics; Subjective measures

Indexed keywords

CARBON MONOXIDE; COTININE; MENTHOL; NICOTINE; NICOTINE GUM; NICOTINIC AGENT;

ABUSE LIABILITY; ADULT; AREA UNDER THE CURVE; ARTICLE; CIGARETTE; CIGARETTE SMOKING; COMBUSTIBLE FILTERED CIGARETTE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CRAVING; CROSSOVER PROCEDURE; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; ELECTRONIC CIGARETTE; EVIDENCE BASED MEDICINE; FEMALE; HEADACHE; HEALTH HAZARD; HUMAN; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; OPEN STUDY; PRIORITY JOURNAL; PUBLIC HEALTH; PULSE RATE; RANDOMIZED CONTROLLED TRIAL; SAFETY; SYSTOLIC BLOOD PRESSURE; TOBACCO DEPENDENCE; VAPING; ADDICTION; MIDDLE AGED; SMOKING; TOBACCO; YOUNG ADULT;

ADULT; BEHAVIOR, ADDICTIVE; CROSS-OVER STUDIES; ELECTRONIC NICOTINE DELIVERY SYSTEMS; FEMALE; HUMANS; MALE; MENTHOL; MIDDLE AGED; NICOTINE; NICOTINE CHEWING GUM; NICOTINIC AGONISTS; SMOKING; TOBACCO; TOBACCO PRODUCTS; TOBACCO SMOKING; YOUNG ADULT;

EID: 85046471088     PISSN: 00333158     EISSN: 14322072     Source Type: Journal    
DOI: 10.1007/s00213-018-4904-x     Document Type: Article

References (39)

1. Abrams DB (2014) Promise and peril of e-cigarettes: can disruptive technology make cigarettes obsolete? JAMA 311(2):135–136. 10.1001/jama.2013.285347
2. Abrams DB, Glasser AM, Pearson JL, Villanti AC, Collins LK, Niaura RS (2017) Harm minimization and tobacco control: reframing societal views of nicotine use to rapidly save lives. Ann Rev Public Health In press
3. Ahijevych K, Garrett BE (2004) Menthol pharmacology and its potential impact on cigarette smoking behavior. Nicotine Tob Res 6(Suppl 1):S17–S28
4. Baweja R, Curci KM, Yingst J, Veldheer S, Hrabovsky S, Wilson SJ, Nichols TT, Eissenberg T, Foulds J (2016) Views of experienced electronic cigarette users. Addict Res Theory 24(1):80–88
5. Benowitz NL, Swan GE, Jacob P 3rd, Lessov-Schlaggar CN, Tyndale RF (2006) CYP2A6 genotype and the metabolism and disposition kinetics of nicotine. Clin Pharmacol Ther 80:457–467. 10.1016/j.clpt.2006.08.011
6. Benowitz NL, Dains KM, Dempsey D, Wilson M, Jacob P (2011) Racial differences in the relationship between number of cigarettes smoked and nicotine and carcinogen exposure. Nicotine Tob Res 13(9):772–783
7. Biener L, Hargraves JL (2015) A longitudinal study of electronic cigarette use among a population-based sample of adult smokers: association with smoking cessation and motivation to quit. Nicotine Tob Res 17(2):127–133
8. Carter LP, Stitzer ML, Henningfield JE, O’Connor RJ, Cummings KM, Hatsukami DK (2009) Abuse liability assessment of tobacco products including potential reduced exposure products. Cancer Epidemiol Biomark Prev 18:3241–3262. 10.1158/1055-9965.EPI-09-0948
9. Etter JF, Bullen C (2011) Electronic cigarette: users profile, utilization, satisfaction and perceived efficacy. Addiction 106:2017–2028
10. Fagerström K, Eissenberg T (2012) Dependence on tobacco and nicotine products: a case for product-specific assessment. Nicotine Tob Res 14(11):1382–1390. 10.1093/ntr/nts007
11. Family Smoking Prevention and Tobacco Control Act (2009) Public law 111-31
12. Federal Trade Commission (2017) Federal Trade Commission cigarette report for 2015. https://www.ftc.gov/system/files/documents/reports/federal-trade-commission-cigarette-report-2015-federal-trade-commission-smokeless-tobacco-report/2015_cigarette_report.pdf. Accessed 17 Jan 2018
13. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2010) Draft guidance for industry: assessment of abuse potential of drugs. http://www.fda.gov/downloads/ drugs/guidance complianceregulatoryinformation/guidances/ucm198650.pdf. Accessed 6 Jul 2017
14. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) (2017) Assessment of abuse potential of drugs: guidance for industry. https://www.fda.gov/downloads/drugs/guidances/ucm198650.pdf. Accessed 15 Aug 2017
15. Goniewicz ML, Knysak J, Gawron M, Kosmider L, Sobczak A, Kurek J, Prokopowicz A, Jablonska-Czapla M, Rosik-Dulewska C, Havel C, Jacob P 3rd, Benowitz N (2014) Levels of selected carcinogens and toxicants in vapour from electronic cigarettes. Tob Control 23(2):133–139
16. Gottlieb S, Zeller M (2017) A nicotine-focused framework for public health. N Engl J Med 377(12):1111–1114. 10.1056/NEJMp1707409
17. Harrell PT, Marquinez NS, Correa JB, Meltzer LR, Unrod M, Sutton SK, Simmons VN, Brandon TH (2015) Expectancies for cigarettes, e-cigarettes, and nicotine replacement therapies among e-cigarette users (aka vapers). Nicotine Tob Res 17(2):193–200
18. Hatsukami DK (2013) Ending tobacco-caused mortality and morbidity: the case for performance standards for tobacco products. Tob Control 22(Supple 1):i36–i37. 10.1136/tobaccocontrol-2012-050785
19. Henningfield JE (2015) Pharmacokinetic and dynamic factors in abuse potential: historical perspectives from research on opioids, stimulants and nicotine. Presented in Symposium X: the interplay of pharmacokinetics and pharmacodynamics in abuse potential: modeling madness? College on Problems of Drug Dependence Annual Meeting. Arizona Biltmore, Phoenix, June 13–18.
20. Henningfield JE, Hatsukami DK, Zeller M, Peters E (2011) Conference on abuse liability and appeal of tobacco products: conclusions and recommendations. Drug Alcohol Depend 116(1–3):1–7. 10.1016/j.drugalcdep.2010.12.009
21. Lawrence D, Cadman B, Hoffman AC (2011) Sensory properties of menthol and smoking topography. Tob Induc Dis 9(Suppl 1):S3
22. McColl S, Sellers EM (2006) Research design strategies to evaluate the impact of formulations on abuse liability. Drug Alcohol Depend 83S:S52–S62. 10.1016/j.drugalcdep.2006.01.015
23. Niaura R (2016) Re-thinking nicotine and its effects. Accessed from: https://truthinitiative.org/sites/default/files/ReThinking-Nicotine.pdf Accessed 7 Sep 2017
24. Royal College of Physicians (2016) Nicotine without smoke: tobacco harm reduction. Accessed from: https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0 Accessed 2 Jan 2018
25. Shiffman S, Paty JA, Gnys M, Kassel JA, Hickcox M (1996) First lapses to smoking: within-subjects analysis of real-time reports. J Consult Clin Psychol 64(2):366–379
26. Shiffman S, Cone EJ, Buchhalter AR, Henningfield JE, Rohay JM, Gitchell JG, Pinney JM, Chau T (2009) Rapid absorption of nicotine from new nicotine gum formulations. Pharmacol Biochem Behav 91:380–384. 10.1016/j.pbb.2008.08.012
27. Shihadeh A, Eissenberg T (2015) Electronic cigarette effectiveness and abuse liability: predicting and regulating nicotine flux. Nicotine Tob Res 17(2):158–162
28. Stiles MF, Campbell LR, Graff DW, Jones BA, Fant RV, Henningfield JE (2017) Pharmacodynamic and pharmacokinetic assessment of electronic cigarettes, combustible cigarettes, and nicotine gum: implications for abuse liability. Psychopharmacol (Berl) doi 234:2643–2655. 10.1007/s00213-17-4665-y
29. The National Academies of Sciences, Engineering, and Medicine (2018) Public health consequences of e-cigarettes. Accessed from: http://nationalacademies.org/hmd/Reports/2018/public-health-consequences-of-e-cigarettes.aspx. Accessed 28 Mar 2018
30. Tucker MR, Laugesesn M, Bullen C, Grace RC (2017) Predicting short-term uptake of electronic cigarettes: effects of nicotine, subjective effects and simulated demand. Nicotine Tob Res. 10.1093/ntr/ntx269
31. U. S. Department of Health and Human Services (2010) How tobacco smoke causes disease: the biology and behavioral basis for smoking-attributable disease: a report of the Surgeon General. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health. U. S. In: Government Printing Office, Washington, D.C.
32. U. S. Department of Health and Human Services (2012) Draft guidance for industry: modified risk tobacco product applications. Accessed from: http://www.fda.gov/downloads/TobaccoProducts/ GuidanceComplianceRegulatoryInformation/UCM297751.pdf. Accessed 6 Jul 2017
33. U. S. Department of Health and Human Services (2014) The health consequences of smoking—50 years of progress: a report of the Surgeon General. Department of Health and Human Services, Public Health Service, Office of the Surgeon General. U. S. In: Government Printing Office, Washington, D.C.
34. U. S. Department of Health and Human Services (2016) Draft guidance for industry: premarket tobacco product applications for electronic nicotine delivery systems. Accessed from: https://www.fda.gov/ downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM499352.pdf. Accessed 28 Mar 2018
35. U.S. Department of Health and Human Services (2011) Draft guidance for industry: applications for premarket review of new tobacco products. Accessed from: https://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf. Accessed 17 Jul 2017
36. Vansickel AR, Weaver MF, Eissenberg T (2012) Clinical laboratory assessment of the abuse liability of an electronic cigarette. Addiction 107:1493–1500. 10.1111/j.1360-0043.2012.03791.x
37. Warner KE, Slade J, Sweanor DT (1997) The emerging market for long-term nicotine maintenance. JAMA 278(13):1087
38. Wickham RJ (2015) How menthol alters tobacco-smoking behavior: a biological perspective. Yale J Biol Med 88(3):279–287
39. Zeller M (2013) Reflections on the ‘endgame’ for tobacco control. Tob Control 22:i40–i41. 10.1136/tobaccocontrol-2012-050789