NCT04188873.

Study name	Optimized chronic care for smokers: developing and implementing integrated clinical and systems interventions in primary care ‐ cessation trial
Methods	Four factor (2 x 2 x 2 x 2) factorial randomised controlled trial Country: USA Recruitment: from primary care
Participants	608 participants; > 18 years old, smoking > 4 cigarettes per day for the previous 6 months
Interventions	2 x 2 x 2 x 2 factorial design (16 possible treatment combinations): 1) Medication type (varenicline versus combination NRT) 2) Preparation medication (4 weeks versus standard) 3) Medication duration (extended (24 weeks) versus standard (12 weeks)) 4) Counselling (intensive versus minimal)
Outcomes	Biochemically‐verified 7‐day PPA at 12 months after target quit date Validation: CO < 5 ppm Adverse events: not listed as an outcome
Starting date	10 December 2020
Contact information	Megan E Piper, University of Wisconsin, Madison 608‐265‐5472; mep@ctri.wisc.edu
Notes	Sponsor: University of Wisconsin, Madison Estimated study completion date: 1 August 2024