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Cunningham JA, Kushnir V, Selby P, et al. Five-Year Follow-up of a Randomized Clinical Trial Testing Mailed Nicotine Patches to Promote Tobacco Cessation. JAMA Intern Med. Published online March 09, 2020. doi:10.1001/jamainternmed.2020.0001
Our previous randomized clinical trial1 demonstrated that smokers receiving nicotine patches by mail (5 weeks of nicotine patches) were more likely to report 30-day point prevalence abstinence at 6 months compared with smokers not mailed nicotine patches. The current project extends this research by recontacting participants after 5 years.
Briefly, attempts were made to recontact participants from the original randomized clinical trial (924 to be recontacted; 75 did not consent to recontact).2 Those contacted and providing verbal informed consent to participate in the follow-up completed a telephone interview asking about current smoking and, for those not currently smoking, length of time since tobacco cessation (ie, 30 days, 6 months, or since the last interview). Attempts were made to relocate those lost to contact. Participants reported as deceased were recorded. The primary outcome was 30-day point prevalence smoking abstinence at 5 years, and the secondary outcome was prolonged 6-month abstinence at 5 years. Analyses were conducted using SPSS version 26 (IBM) and used logistic regressions with a 2-tail test, with a P value less than .05 indicating significance. The project was approved by the Centre for Addiction and Mental Health standing institutional review board.
Of the 999 initial participants, a total of 518 were successfully recontacted and interviewed, including 258 of 500 participants randomized to the intervention group and 260 of 499 participants randomized to the control group. Of the 518 respondents, 276 (53.3%) were female, and the mean (SD) age was 55.9 (11.4) years.
Compared with participants who did not receive mailed nicotine patches, those who received mailed nicotine patches at baseline did not report increased tobacco cessation rates at 5-year follow-up (30-day point prevalence abstinence, 11.2% [56 of 499] vs 12.4% [62 of 500]; odds ratio [OR], 1.12; 95% CI, 0.76-1.65; P = .56; prolonged 6-month abstinence, 8.6% [43 of 499] vs 10.8% [54 of 500]; OR, 1.28; 95% CI, 0.84-1.96; P = .25). Participants who were not recontacted (n = 481) were assumed to be confirmed smokers.
Compared with participants who did not receive patches, those who received nicotine patches at baseline and reported using them by posttreatment (8 weeks; n = 246) did not report increased 30-day tobacco cessation rates at 5-year follow-up (11.2% [56 of 499] vs 14.6% [36 of 246]; OR, 1.36; 95% CI, 0.87-2.13; P = .18). However, compared with participants who did not receive patches, the rate of prolonged 6-month abstinence at the time of the 5-year follow-up was higher among participants who used the patches (8.6% [43 of 499] vs 13.4% [33 of 246]; OR, 1.64; 95% CI, 1.02-2.66; P = .04), and the death rate was lower (4.8% [24 of 499] vs 1.6% [4 of 246]; OR, 0.33; 95% CI, 0.11-0.95; P = .04).
Providing a single course of free nicotine patches by mail to a proactively recruited general population sample of smokers did not lead to increases in 5-year tobacco cessation. Further, the evidence that the tobacco cessation rate was higher at 5 years among the subgroup who used the patches compared with the control group who did not receive patches is ambiguous. This means that lower death rates at 5 years among persons who used the patches likely reflect the tendency of these individuals to follow generally healthier practices (or to have different characteristics at baseline)3 rather than being the result of the mailed nicotine patch intervention. Limitations of our trial include that responses were self-reported and that only half of participants could be recontacted and agreed to participate in the 5-year follow-up.
There is value, at least in the short term, to use nicotine patches as part of large-scale initiatives to promote tobacco cessation among smokers in the general public.4 However, additional supports and interventions will be needed to maintain tobacco cessation.
Accepted for Publication: December 29, 2019.
Corresponding Author: John A. Cunningham, PhD, Centre for Addiction and Mental Health, 33 Russell St, Toronto, ON M5S 2S1, Canada (firstname.lastname@example.org).
Published Online: March 9, 2020. doi:10.1001/jamainternmed.2020.0001
Author Contributions: Dr Cunningham had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Cunningham, Kushnir, Selby, Leatherdale.
Acquisition, analysis, or interpretation of data: Cunningham, Zawertailo, Tyndale, Schell.
Drafting of the manuscript: Cunningham, Leatherdale.
Critical revision of the manuscript for important intellectual content: Cunningham, Kushnir, Selby, Zawertailo, Tyndale, Schell.
Statistical analysis: Cunningham, Schell.
Obtained funding: Cunningham, Kushnir, Selby, Zawertailo.
Administrative, technical, or material support: Kushnir, Schell.
Study supervision: Cunningham.
Conflict of Interest Disclosures: Dr Selby has received salary support for his research time from the Clinician Scientist program at the Department of Family and Community Medicine at the University of Toronto and from the Centre for Addiction and Mental Health; grants from Pfizer, Shoppers Drug Mart, Bhasin Consulting Fund, Patient-Centered Outcomes Research Institute, Canadian Institutes of Health, Health Canada, and Canadian Cancer Society Research Institute; honorarium from Bristol-Myers Squibb; personal fees for consulting from Pfizer Canada, Evidera Inc, Johnson & Johnson, Medcan Clinic, Miller Medical Communications, and NVision Insight Group; and personal fees for serving on advisory boards from Pfizer Canada and Johnson & Johnson. Dr Zawertiailo has received investigator-initiated grant support from Pfizer Canada. Dr Tyndale has received personal fees for consulting from Quinn Emanuel Urquhart & Sullivan and Ethismos Research; serves on the scientific advisory boards of Health Canada, the Canadian Centre on Substance Use and Addiction, and Nicosurge; and has received unrestricted funds to her institution under the Global Research Award for Nicotine Dependence funding mechanism. Dr Leatherdale is a Chair in Applied Public Health funded by the Public Health Agency of Canada in partnership with the Canadian Institutes of Health Research Institute of Neurosciences, Mental Health, and Addiction and the Institute of Population and Public Health. No other disclosures were reported.
Funding/Support: This research is funded by grant 704949 from the Canadian Cancer Society. This research was undertaken in part thanks to funding from the Canada Research Chairs program supporting Drs Cunningham (Canada Research Chair in Addictions) and Tyndale (Canada Research Chair in Pharmacogenomics).
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Trial Registration: ClinicalTrials.gov Identifier: NCT03097445
Disclaimer: The views expressed in this article do not necessarily reflect those of the Ontario Ministry of Health and Long-Term Care.
Additional Contributions: We thank Alexandra Godinho, MSc (Centre for Addiction and Mental Health, Toronto, Ontario, Canada), for her contribution to the design of the study, acquisition of data, and drafting of the manuscript. She was compensated for her work.
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