Zawertailo 2020.

Study name	Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence
Methods	Parallel randomised controlled trial Country: Canada Recruitment: from community and smoking cessation treatment clinics at 2 study sites, using pamphlets, posters, radio and social media
Participants	500 smokers of 10+ cigarettes per day; aged 18 to 75 years, interested in using nicotine patch and quitting within next 30 days
Interventions	2‐week run‐in period using 21 mg nicotine patch daily. Those who have not stopped smoking at the end of 2 weeks are randomised to: 1) Daily 21 mg NRT patch plus placebo patch (same titration, maintenance and tapering regime as intervention arm) 2) Daily 21 mg NRT patch plus additional NRT patch at a dose based on tolerability and cigarettes per day for 5 weeks of titration and 5 weeks of maintenance, then tapering down by 7 mg/week. Both study arms receive brief behavioural support weekly.
Outcomes	Continuous abstinence from week 9 to weeks 26 and 52 Validation: urinary cotinine measurement Adverse events: not listed as an outcome
Starting date	January 2018
Contact information	Peter Selby, Centre for Addiction and Mental Health, Toronto peter.selby@camh.ca
Notes	Sponsor: Canadian Cancer Society Research Institute Clinicaltrials.gov ID: NCT03000387. Estimated primary completion date: December 2022

CO: carbon monoxide in exhaled air; PPA: point prevalence abstinence; ppm: parts per million