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Research Letter
March 9, 2020

Five-Year Follow-up of a Randomized Clinical Trial Testing Mailed Nicotine Patches to Promote Tobacco Cessation

Author Affiliations
  • 1Centre for Addiction and Mental Health, Toronto, Ontario, Canada
  • 2Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada
  • 3Research School of Population Health, the Australian National University, Canberra, Australia
  • 4St Michael’s Hospital, Toronto, Ontario, Canada
  • 5Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
  • 6Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
  • 7Department of Pharmacology and Toxicology, University of Toronto, Toronto, Ontario, Canada
  • 8School of Public Health and Health Systems, University of Waterloo, Waterloo, Ontario, Canada
JAMA Intern Med. Published online March 9, 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.

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