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The Avenues Study: Dual Use Cessation
Sponsor: University of Wisconsin, Madison
Summary
The overarching goal of this research is to determine the most effective approach for helping dual users of cigarettes and electronic nicotine delivery systems (ENDS) quit smoking. 500 participants will be enrolled and can expect to be on study for 12 months.
Official title: Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-09-24
Completion Date
2028-07
Last Updated
2025-10-30
Healthy Volunteers
No
Interventions
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.
Locations (1)
University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, United States