Abstract
Objective
To examine the effects of five intervention components on smokers’ adherence to combined nicotine patch and nicotine gum during a quit attempt and assess whether adherence is related to cessation.
Method
Smokers interested in quitting (N = 513; 59% female; 87% White) received nicotine patch plus nicotine gum and participated in a 2x2x2x2x2 randomized factorial experiment (i.e., 32 treatment conditions) evaluating five intervention components: (1) medication adherence counseling versus none; (2) automated medication adherence calls versus none; (3) electronic medication monitoring with feedback and counseling versus e-monitoring alone; (4) 26 versus 8 weeks of nicotine patch plus nicotine gum; and (5) maintenance counseling versus none. Adherence was assessed over the first 6 weeks post-target quit day via timeline follow-back (nicotine patch) and electronic medication dispenser (gum).
Results
In the first 6 weeks post-quit day, 12% of participants used no patches or gum, and 40% used the patch every day. Only 1.4% used both patch and gum adherently every day in the 6 weeks post-target quit day. E-monitoring counseling increased gum use (from 1.9 to 2.6 pieces/day; p < .001) but did not increase abstinence. More adherent patch and gum use in the first 6 weeks were each associated with higher point-prevalence abstinence rates through 1 year.
Conclusions
This large experiment with electronic monitoring of nicotine gum adherence showed that e-monitoring counseling increased gum use but not abstinence. Adherence to nicotine patch and to gum were each strongly related to abstinence, but it is unclear whether adherence increases abstinence, or relapse causes medication discontinuation.
Clinical Trial Registration
ClinicalTrials.gov NCT01120704.
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References
Balmford J, Borland R, Hammond D, Cummings KM (2011) Adherence to and reasons for premature discontinuation from stop-smoking medications: data from the ITC four-country survey. Nicotine Tob Res 13:94–102. https://doi.org/10.1093/ntr/ntq215
Benjamini Y, Yekutieli D (2001) The control of the false discovery rate in multiple testing under dependency. Ann Stat 29:1165–1188
Burns EK, Levinson AH (2008) Discontinuation of nicotine replacement therapy among smoking-cessation attempters. Am J Prev Med 34:212–215. https://doi.org/10.1016/j.amepre.2007.11.010
Catz SL, Jack LM, McClure JB, Javitz HS, Deprey M, Zbikowski SM, McAfee T, Richards J, Swan GE (2011) Adherence to varenicline in the COMPASS smoking cessation intervention trial. Nicotine Tob Res 13:361–368. https://doi.org/10.1093/ntr/ntr003
Checchi KD, Huybrechts KF, Avorn J, Kesselheim AS (2014) Electronic medication packaging devices and medication adherence: a systematic review. JAMA 312:1237–1247. https://doi.org/10.1001/jama.2014.10059
Cropsey KL, Hendricks PS, Schiavon S, Sellers A, Froelich M, Shelton RC, Carpenter MJ (2017) A pilot trial of In vivo NRT sampling to increase medication adherence in community corrections smokers. Addict Behav 67:92–99. https://doi.org/10.1016/j.addbeh.2016.12.011
Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, Ezzati M (2009) The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med 6:e1000058
De Bleser L, Vincke B, Dobbels F, Happ MB, Maes B, Vanhaecke J, De Geest S (2010) A new electronic monitoring device to measure medication adherence: usability of the helping hand. Sensors 10:1535–1552. https://doi.org/10.3390/s100301535
Etter JF, Huguelet P, Perneger TV, Cornuz J (2009) Nicotine gum treatment before smoking cessation: a randomized trial. Arch Intern Med 169:1028–1034. https://doi.org/10.1001/archinternmed.2009.12
Ferguson SG, Gitchell JG, Shiffman S (2012) Continuing to wear nicotine patches after smoking lapses promotes recovery of abstinence. Addiction 107:1349–1353. https://doi.org/10.1111/j.1360-0443.2012.03801.x
Ferrari P, Cribari-Neto F (2004) Beta regression for modelling rates and proportions. J Appl Stat 31:799–815
Fiore MC, et al. (2008) Treating tobacco use and dependence: 2008 update. U.S. Department of Health and Human Services, U.S. Public Health Service
Fraser D, Christiansen BA, Adsit R, Baker TB, Fiore MC (2013) Electronic health records as a tool for recruitment of participants' clinical effectiveness research: lessons learned from tobacco cessation. Transl Behav Med 3:244–252. https://doi.org/10.1007/s13142-012-0143-6
Hollands GJ, Sutton S, McDermott MS, Marteau TM, Aveyard P (2013) Adherence to and consumption of nicotine replacement therapy and the relationship with abstinence within a smoking cessation trial in primary care. Nicotine Tob Res 15:1537–1544. https://doi.org/10.1093/ntr/ntt010
Hughes JR, Keely J, Naud S (2004) Shape of the relapse curve and long-term abstinence among untreated smokers. Addiction 99:29–38
Japuntich SJ, Piper ME, Leventhal AM, Bolt DM, Baker TB (2011) The effect of five smoking cessation pharmacotherapies on smoking cessation milestones. J Consult Clin Psychol 79:34–42. https://doi.org/10.1037/a0022154
Kerr T, Palepu A, Barness G, Walsh J, Hogg R, Montaner J, Tyndall M, Wood E (2004) Psychosocial determinants of adherence to highly active antiretroviral therapy among injection drug users in Vancouver. Antivir Ther 9:407–414
Lam TH, Abdullah AS, Chan SS, Hedley AJ (2005) Adherence to nicotine replacement therapy versus quitting smoking among Chinese smokers: a preliminary investigation. Psychopharmacology 177:400–408. https://doi.org/10.1007/s00213-004-1971-y
Ma P, Kendzor DE, Poonawalla IB, Balis DS, Businelle MS (2016) Daily nicotine patch wear time predicts smoking abstinence in socioeconomically disadvantaged adults: an analysis of ecological momentary assessment data. Drug Alcohol Depend 169:64–67. https://doi.org/10.1016/j.drugalcdep.2016.10.013
May S, West R, Hajek P, Nilsson F, Foulds J, Meadow A (2003) The use of videos to inform smokers about different nicotine replacement products. Patient Educ Couns 51:143–147
Medioni J, Berlin I, Mallet A (2005) Increased risk of relapse after stopping nicotine replacement therapies: a mathematical modelling approach. Addiction 100:247–254. https://doi.org/10.1111/j.1360-0443.2004.00961.x
Mooney M, Babb D, Jensen J, Hatsukami D (2005) Interventions to increase use of nicotine gum: a randomized, controlled, single-blind trial. Nicotine Tob Res 7:565–579
Mooney ME, Leventhal AM, Hatsukami DK (2006) Attitudes and knowledge about nicotine and nicotine replacement therapy. Nicotine Tob Res 8:435–446. https://doi.org/10.1080/14622200500185637
Mooney ME, Sayre SL, Hokanson PS, Stotts AL, Schmitz JM (2007) Adding MEMS feedback to behavioral smoking cessation therapy increases compliance with bupropion: a replication and extension study. Addict Behav 32:875–880. https://doi.org/10.1016/j.addbeh.2006.06.022
Morisky DE, Green LW, Levine DM (1986) Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 24:67–74
Neame R, Hammond A (2005) Beliefs about medications: a questionnaire survey of people with rheumatoid arthritis. Rheumatology 44:762–767. https://doi.org/10.1093/rheumatology/keh587
Nieuwlaat R, Wilczynski N., Navarro T., Hobson N., Jeffery R., Keepanasseril A., Agoritsas T., Mistry N., Iorio A., Jack S., Sivaramalingam B., Iserman E., Mustafa R.A., Jedraszewski D., Cotoi C., Haynes R.B., Cochrane Consumers and Communication Group (2014) Interventions for enhancing medication adherence. Cochrane Database Syst Rev:CD000011. doi:https://doi.org/10.1002/14651858.CD000011.pub
Pacek LR, McClernon FJ, Bosworth HB (2017) Adherence to pharmacological smoking cessation interventions: a literature review and synthesis of correlates and barriers. Nicotine Tob Res [Epub ahead of print]. https://doi.org/10.1093/ntr/ntx210
Piper ME, Baker TB, Mermelstein R, Collins LM, Fraser DL, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Oguss M, Fiore MC (2013) Recruiting and engaging smokers in treatment in a primary care setting: developing a chronic care model implemented through a modified electronic health record. Transl Behav Med 3:253–263. https://doi.org/10.1007/s13142-012-0178-8
Raupach T, Brown J, Herbec A, Brose L, West R (2014) A systematic review of studies assessing the association between adherence to smoking cessation medication and treatment success. Addiction 109:35–43. https://doi.org/10.1111/add.1231
Robinson SM, Sobell LC, Sobell MB, Leo GI (2014) Reliability of the timeline followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav 28:154–162. https://doi.org/10.1037/a003099
Schlam TR, Fiore MC, Smith SS, Fraser D, Bolt DM, Collins LM, Mermelstein R, Piper ME, Cook JW, Jorenby DE, Loh WY, Baker TB (2016) Comparative effectiveness of intervention components for producing long-term abstinence from smoking: a factorial screening experiment. Addiction 111:142–155. https://doi.org/10.1111/add.13153
Schmitz JM, Sayre SL, Stotts AL, Rothfleisch J, Mooney ME (2005) Medication compliance during a smoking cessation clinical trial: a brief intervention using MEMS feedback. J Behav Med 28:139–147
Shiffman S, Hughes JR, Di Marino ME, Sweeney CT (2003) Patterns of over-the-counter nicotine gum use: persistent use and concurrent smoking. Addiction 98:1747–1753
Shiffman S, Scharf DM, Shadel WG, Gwaltney CJ, Dang Q, Paton SM, Clark DB (2006) Analyzing milestones in smoking cessation: illustration in a nicotine patch trial in adult smokers. J Consult Clin Psychol 74:276–285. https://doi.org/10.1037/0022-006X.74.2.276
Shiffman S, Sweeney CT, Ferguson SG, Sembower MA, Gitchell JG (2008) Relationship between adherence to daily nicotine patch use and treatment efficacy: secondary analysis of a 10-week randomized, double-blind, placebo-controlled clinical trial simulating over-the-counter use in adult smokers. Clin Ther 30:1852–1858. https://doi.org/10.1016/j.clinthera.2008.09.016
Smith SS, Keller PA, Kobinsky KH, Baker TB, Fraser DL, Bush T, Magnusson B, Zbikowski SM, McAfee TA, Fiore MC (2013) Enhancing tobacco quitline effectiveness: identifying a superior pharmacotherapy adjuvant. Nicotine Tob Res 15:718–728. https://doi.org/10.1093/ntr/nts186
Smithson M, Verkuilen J (2006) A better lemon squeezer? Maximum-likelihood regression with beta-distributed dependent variables. Psychol Methods 11:54–71. https://doi.org/10.1037/1082-989X.11.1.54
Stirratt MJ, Dunbar-Jacob J, Crane HM, Simoni JM, Czajkowski S, Hilliard ME, Aikens JE, Hunter CM, Velligan DI, Huntley K, Ogedegbe G, Rand CS, Schron E, Nilsen WJ (2015) Self-report measures of medication adherence behavior: recommendations on optimal use. Trans Behav Med 5:470–482. https://doi.org/10.1007/s13142-015-0315-2
Tyndale RF, Zhu AZX, George TP, Cinciripini P, Hawk LW, Schnoll RA, Swan GE, Benowitz NL, Heitjan DF, Lerman C, PGRN-PNAT Research Group (2015) Lack of associations of CHRNA5-A3-B4 genetic variants with smoking cessation treatment outcomes in caucasian smokers despite associations with baseline smoking. PLoS One 10:e0128109. https://doi.org/10.1371/journal.pone.0128109
Wiggers LC, Smets EM, Oort FJ, Storm-Versloot MN, Vermeulen H, van Loenen LB, Peters RJ, de Haes HC, Legemate DA (2006) Adherence to nicotine replacement patch therapy in cardiovascular patients. Int J Behav Med 13:79–88. https://doi.org/10.1207/s15327558ijbm1301_10
World Health Organization (ed) (2003) Disease-specific reviews: tobacco smoking cessation. Pages 115–120 in World Health Organization, ed. Evidence for action. Geneva, Adherence to long-term therapies
Acknowledgments
We would like to acknowledge the staff at Aurora Health Care, Deancare, and Epic Systems Corporation for their collaboration in this research. We are very grateful to the staff and students at the Center for Tobacco Research and Intervention in the University of Wisconsin School of Medicine and Public Health for their help with this research.
Funding
This research was supported by grants 15P50CA143188, 1P01CA180945, and 1K05CA139871 from the National Cancer Institute to the University of Wisconsin Center for Tobacco Research and Intervention and by the Wisconsin Partnership Program. Dr. Cook is also supported by Merit Review Award 101CX00056 from the US Department of Veterans Affairs.
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The study was approved by the University of Wisconsin Health Sciences Institutional Review Board, and all participants gave written informed consent.
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The authors declare that they have no conflict of interest.
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Schlam, T.R., Cook, J.W., Baker, T.B. et al. Can we increase smokers’ adherence to nicotine replacement therapy and does this help them quit?. Psychopharmacology 235, 2065–2075 (2018). https://doi.org/10.1007/s00213-018-4903-y
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DOI: https://doi.org/10.1007/s00213-018-4903-y