Tobacco harm reduction with vaporised nicotine (THRiVe): The study protocol of an uncontrolled feasibility study of novel nicotine replacement products among people living with HIV who smoke

International Journal of Environmental Research and Public Health

Volumn 14, Issue 7, 2017, Pages

  Bell, Stephanie ^a   Dean, Judith ^a   Gilks, Charles ^a   Boyd, Mark A ^b   Fitzgerald, Lisa ^a   Mutch, Allyson ^a   Baker, Peter ^a   Neilsen, Graham ^a,c   Gartner, Coral E ^a  

^a UNIVERSITY OF QUEENSLAND   (Australia)

^b UNIVERSITY OF ADELAIDE   (Australia)

^c METRO NORTH HOSPITAL AND HEALTH SERVICE   (Australia)

Author keywords

E cigarettes; Feasibility; Harm reduction; HIV; Smoking; Tobacco; Vaporised nicotine; VNPs

Indexed keywords

NICOTINE DERIVATIVE; UNCLASSIFIED DRUG; VAPORISED NICOTINE PRODUCT; NICOTINE GUM;

ELECTRONIC EQUIPMENT; FEASIBILITY STUDY; HUMAN IMMUNODEFICIENCY VIRUS; SAMPLING; SMOKING; SURVEY; TOBACCO;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL PROTOCOL; CONTROLLED STUDY; DEVICE SAFETY; DRUG SAFETY; FEASIBILITY STUDY; HARM REDUCTION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; NICOTINE REPLACEMENT THERAPY; PATIENT ATTITUDE; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY THERAPEUTIC DEVICE; SMOKING; SMOKING CESSATION; TOBACCO DEPENDENCE; VAPING; NEBULIZER; PROCEDURES; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SMOKING PREVENTION;

NICOTIANA TABACUM;

CLINICAL PROTOCOLS; FEASIBILITY STUDIES; HARM REDUCTION; HIV INFECTIONS; HUMANS; NEBULIZERS AND VAPORIZERS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SMOKING CESSATION; SMOKING PREVENTION; SURVEYS AND QUESTIONNAIRES; TOBACCO USE CESSATION PRODUCTS;

EID: 85025097409     PISSN: 16617827     EISSN: 16604601     Source Type: Journal    
DOI: 10.3390/ijerph14070799     Document Type: Article

References (47)

1. Nakagawa, F.; May, M.; Phillips, A. Life expectancy living with HIV: Recent estimates and future implications. Curr. Opin. Infect. Dis. 2013, 26, 17–25. [CrossRef] [PubMed]
2. Petoumenos, K.; Law, M.G. Smoking, alcohol and illicit drug use effects on survival in HIV-positive persons. Curr. Opin. HIV AIDS 2016, 11, 514–520. [CrossRef] [PubMed]
3. Hunt, P.W. HIV and inflammation: Mechanisms and consequences. Curr. HIV/AIDS Rep. 2012, 9, 139–147. [CrossRef] [PubMed]
4. Shirley, D.K.; Kaner, R.J.; Glesby, M.J. Effects of smoking on non-AIDS-related morbidity in HIV-infected patients. Clin. Infect. Dis. 2013, 57, 275–282. [CrossRef] [PubMed]
5. Fuster, M.; Estrada, V.; Fernandez-Pinilla, M.C.; Fuentes-Ferrer, M.E.; Tellez, M.J.; Vergas, J.; Serrano-Villar, S.; Fernandez-Cruz, A. Smoking cessation in HIV patients: Rate of success and associated factors. HIV Med. 2009, 10, 614–619. [CrossRef] [PubMed]
6. Mdodo, R.; Frazier, E.L.; Dube, S.R.; Mattson, C.L.; Sutton, M.Y.; Brooks, J.T.; Skarbinski, J. Cigarette smoking prevalence among adults with HIV compared with the general adult population in the United States: Cross-sectional surveys. Ann. Intern. Med. 2015, 162, 335–344. [CrossRef] [PubMed]
7. Petoumenos, K.; Worm, S.; Reiss, P.; de Wit, S.; d’Arminio Monforte, A.; Sabin, C.; Friis-Møller, N.; Weber, R.; Mercie, P.; Pradier, C. et al. Rates of cardiovascular disease following smoking cessation in patients with HIV infection: Results from the D:A:D study. HIV Med. 2011, 12, 412–421. [CrossRef] [PubMed]
8. Helleberg, M.; Afzal, S.; Kronborg, G.; Larsen, C.S.; Pedersen, G.; Pedersen, C.; Gerstoft, J.; Nordestgaard, B.G.; Obel, N. Mortality attributable to smoking among HIV-1-infected individuals: A nationwide, population-based cohort study. Clin. Infect. Dis. 2013, 56, 727–734. [CrossRef] [PubMed]
9. Helleberg, M.; May, M.T.; Ingle, S.M.; Dabis, F.; Reiss, P.; Fätkenheuer, G.; Costagliola, D.; d’Arminio, A.; Cavassini, M.; Smith, C. et al. Smoking and life expectancy among HIV-infected individuals on antiretroviral therapy in Europe and North America. AIDS 2015, 29, 221–229. [CrossRef] [PubMed]
10. Humfleet, G.L.; Delucchi, K.; Kelley, K.; Hall, S.M.; Dilley, J.; Harrison, G. Characteristics of HIV-positive cigarette smokers: A sample of smokers facing multiple challenges. AIDS Educ. Prev. 2009, 21, 54–64. [CrossRef] [PubMed]
11. Vidrine, D.J. Cigarette smoking and HIV/AIDs: Health implications, smoker characteristics and cessation strategies. AIDS Educ. Prev. 2009, 21, 3–13. [CrossRef] [PubMed]
12. Mamary, E.M.; Bahrs, D.; Martinez, S. Cigarette smoking and the desire to quit among individuals living with HIV. AIDS Patient Care STDS 2002, 16, 39–42. [CrossRef] [PubMed]
13. Tesoriero, J.M.; Gieryic, S.M.; Carrascal, A.; Lavigne, H.E. Smoking among HIV positive New Yorkers: Prevalence, frequency, and opportunities for cessation. AIDS Behav. 2010, 14, 824–835. [CrossRef] [PubMed]
14. Shuter, J.; Bernstein, S.L.; Moadel, A.B. Cigarette smoking behaviors and beliefs in persons living with HIV/AIDS. Am. J. Health Behav. 2012, 36, 75–85. [CrossRef] [PubMed]
15. Burkhalter, J.E.; Springer, C.M.; Chhabra, R.; Ostroff, J.S.; Rapkin, B.D. Tobacco use and readiness to quit smoking in low-income HIV-infected persons. Nicotine Tob. Res. 2005, 7, 511–522. [CrossRef] [PubMed]
16. Pool, E.R.M.; Dogar, O.; Lindsay, R.P.; Weatherburn, P.; Siddiqi, K. Interventions for tobacco use cessation in people living with HIV and AIDS. Cochrane Database Syst. Rev. 2016. [CrossRef]
17. National Institute for Health and Care Excellence (NICE). Tobacco: Harm-Reduction Approaches to Smoking; National Institute for Health and Care Excellence (NICE): London, UK, 2013.
18. McNeill, A.; Munafo, M.R. Reducing harm from tobacco use. J. Psychopharmacol. 2013, 27, 13–18. [CrossRef] [PubMed]
19. Wodak, A.; McLeod, L. The role of harm reduction in controlling HIV among injecting drug users. AIDS 2008, 22, 81–92. [CrossRef] [PubMed]
20. World Health Organization (WHO). A New Health Sector Agenda for HIV/AIDS Global Health Sector Strategy on HIV/AIDS, 2011–2015; WHO: Geneva, Switzerland, 2011.
21. Ball, A.L. HIV, injecting drug use and harm reduction: A public health response. Addiction 2007, 102, 684–690. [CrossRef] [PubMed]
22. Tobacco Advisory Group of the Royal College of Physicians. Harm Reduction in Nicotine Addiction: Helping People Who Can’t Quit; RCP: London, UK, 2007.
23. McRobbie, H.; Bullen, C.; Hartmann-Boyce, J.; Hajek, P. Electronic cigarettes for smoking cessation and reduction. Cochrane Database Syst. Rev. 2014. [CrossRef]
24. Royal College of Physicians. Nicotine without Smoke: Tobacco Harm Reduction; RCP: London, UK, 2016.
25. McNeill, A.; Brose, L.S.; Calder, R.; Hitchman, S.C.; Hajek, P.; McRobbie, H. E-Cigarettes: An Evidence Update a Report Commissioned by Public Health England; Public Health England: London, UK, 2015.
26. Shiffman, S.; Hughes, J.R.; Pillitteri, J.L.; Burton, S.L. Persistent use of nicotine replacement therapy: An analysis of actual purchase patterns in a population based sample. Tob. Control 2003, 12, 310–316. [CrossRef] [PubMed]
27. Dawkins, L.; Turner, J.; Hasna, S.; Soar, K. The electronic-cigarette: Effects on desire to smoke, withdrawal symptoms and cognition. Addict. Behav. 2012, 37, 970–973. [CrossRef] [PubMed]
28. Wagener, T.L.; Floyd, E.L.; Stepanov, I.; Driskill, L.M.; Frank, S.G.; Meier, E.; Leavens, E.L.; Tackett, A.P.; Molina, N.; Queimado, L. Have combustible cigarettes met their match? The nicotine delivery profiles and harmful constituent exposures of second-generation and third-generation electronic cigarette users. Tob. Control 2017. [CrossRef] [PubMed]
29. Rahman, M.A.; Hann, N.; Wilson, A.; Mnatzaganian, G.; Worrall-Carter, L. E-cigarettes and smoking cessation: Evidence from a systematic review and meta-analysis. PLoS ONE 2015, 10, e0122544. [CrossRef] [PubMed]
30. Brown, J.; West, R.; Beard, E.; Michie, S.; Shahab, L.; McNeill, A. Prevalence and characteristics of e-cigarette users in Great Britain: Findings from a general population survey of smokers. Addict. Behav. 2014, 39, 1120–1125. [CrossRef] [PubMed]
31. West, R.; Brown, J.; Beard, E. Trends in Electronic Cigarette Use in England. Available online: www.smokinginengland.info/(accessed on 18 October 2014).
32. Creswell, J.W. A Concise Introduction to Mixed Methods Research; SAGE Publications: Thousand Oaks, CA, USA, 2015.
33. Dawkins, L.; Turner, J.; Roberts, A.; Soar, K. ‘Vaping’ profiles and preferences: An online survey of electronic cigarette users. Addiction 2013, 108, 1115–1125. [CrossRef] [PubMed]
34. Mendelsohn, C.; Gartner, C. Electronic cigarettes. What should you tell your patients? Med. Today 2015, 16, 26–32.
35. Heatherton, T.F.; Kozlowski, L.T.; Frecker, R.C.; Fagerstrom, K.O. The fagerstrom test for nicotine dependence. Br. J. Addict. 1991, 86, 1119–1127. [CrossRef] [PubMed]
36. Glover, E.D.; Nilsson, F.; Westin, Å.; Glover, P.N.; Laflin, M.T.; Persson, B. Developmental history of the Glover-Nilsson Smoking Behavioral Questionnaire. Am. J. Health Behav. 2005, 29, 443–455. [CrossRef] [PubMed]
37. Fagerstrom, K.O.; Tejding, R.; Westin, A.; Lunell, E. Aiding reduction of smoking with nicotine replacement medications: Hope for the recalcitrant smoker? Tob. Control 1997, 6, 311–316. [CrossRef] [PubMed]
38. Bolliger, C.T.; Zellweger, J.; Danielsson, T.; van Biljon, X.; Robidou, A.; Westin, Å.; Perruchoud, A.; Säwe, U. Smoking reduction with oral nicotine inhalers: Double blind, randomised clinical trial of efficacy and safety. BMJ 2000, 321, 329–333. [CrossRef] [PubMed]
39. Schulz, K.F.; Altman, D.G.; Moher, D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomized trials. Ann. Intern. Med. 2010, 152, 726–732. [CrossRef] [PubMed]
40. IBM Corp. IBM SPSS Statistics for Windows, Version 23.0; IBM Corp.: Armonk, NY, USA, 2015.
41. Corbin, J.M.; Strauss, A.L. Basics of Qualitative Research: Techniques and Procedures for Developing Grounded Theory; Sage Publications: Thousand Oaks, CA, USA, 2008.
42. Lloyd-Richardson, E.E.; Stanton, C.A.; Papandonatos, G.D.; Shadel, W.G.; Stein, M.; Tashima, K.; Flanigan, T.; Morrow, K.; Neighbors, C.; Niaura, R. Motivation and patch treatment for HIV + smokers: A randomized controlled trial. Addiction 2009, 104, 1891–1900. [CrossRef] [PubMed]
43. Peikes, D.; Geonnotti, K.; Wang, W. Using Pragmatic Clinical Trials to Test the Effectiveness of Patient-Centered Medical Home Models in Real-World Settings; Agency for Healthcare Research and Quality: Rockville, MD, USA, 2013.
44. Zhu, S.; Sun, J.Y.; Bonnevie, E.; Cummins, S.; Gamst, A.; Yin, L.; Lee, M. Four hundred and sixty brands of e-cigarettes and counting: Implications for product regulation. Tob. Control 2014, 23, 33–39. [CrossRef] [PubMed]
45. Farsalinos, K.E.; Romagna, G.; Tsiapras, D.; Kyrzopoulos, S.; Spyrou, A.; Voudris, V. Impact of flavour variability on electronic cigarette use experience: An internet survey. Int. J. Environ. Res. Public Health 2013, 10, 7272–7282. [CrossRef] [PubMed]
46. Allen, J.G.; Flanigan, S.S.; LeBlanc, M.; Vallarino, J.; MacNaughton, P.; Stewart, J.H.; Christiani, D.C. Flavoring chemicals in e-cigarettes: Diacetyl, 2,3-pentanedione, and acetoin in a sample of 51 products, including fruit, candy-, and cocktail-flavored e-cigarettes. Environ. Health Perspect. 2016, 124, 733–739. [CrossRef] [PubMed]
47. Tierney, P.A.; Karpinski, C.D.; Brown, J.E.; Luo, W.; Pankow, J.F. Flavour chemicals in electronic cigarette fluids. Tob. Control 2016, 25, 10–15. [CrossRef] [PubMed]