500
Participants
Start Date
September 24, 2024
Primary Completion Date
July 31, 2028
Study Completion Date
July 31, 2028
Varenicline
0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (at least 8 hours apart) for 4 days prior to the TQD. On the 8th day (the TQD), participants will increase to their target maintenance dose of a 1 mg pill twice daily
Nicotine patch
Following package inserts starting on the TQD, participants who smoke \>10 cigarettes per day at baseline will be given 8 weeks of 21 mg nicotine patches, followed by 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Participants who smoke ≤10 cigarettes per day at baseline will be given 10 weeks of 14 mg nicotine patches followed by 2 weeks of 7 mg patches.
Dual Focused Cessation Counseling
Dual Focused Cessation Counseling will focus on quitting both smoking and vaping. Specifically, participants will be instructed to change smoking and vaping patterns (e.g., not smoking or vaping in specific places such as the car or at specific times of day) prior to quitting and to practice cessation coping strategies (e.g., distraction techniques, getting social support).
Smoking Focused Cessation Counseling
Smoking Focused Cessation Counseling will focus on quitting smoking and using ENDS as a harm reduction strategy (i.e., using ENDS as a substitute for cigarettes).
Counseling Intensity: 1 Session
Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
Counseling Intensity: 4 Sessions
Participants assigned to intensive counseling will have four, 15-20-minute sessions.
RECRUITING
University of Wisconsin-Madison School of Medicine and Public Health, Madison
National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER