Clinical trial NCT06474299: The Avenues Study: Dual Use Cessation
Official title: Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Conditions: Smoking Cessation
Electronic Cigarette Use
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.
Interventions:
description: 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
name: Varenicline
type: Drug
description: 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.
name: Nicotine patch
type: Drug
description: 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).
name: Dual Focused Cessation Counseling
type: Behavioral
description: 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).
name: Smoking Focused Cessation Counseling
type: Behavioral
description: Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).
name: Counseling Intensity: 1 Session
type: Other
description: Participants assigned to intensive counseling will have four, 15-20-minute sessions.
name: Counseling Intensity: 4 Sessions
type: Other
Study arms:
design_group_title: Varenicline, Dual Focused, 1 session
design_group_type: Active Comparator
design_group_title: Varenicline, Dual Focused, 4 sessions
design_group_type: Active Comparator
design_group_title: Varenicline, Smoking Focused, 1 session
design_group_type: Active Comparator
design_group_title: Varenicline, Smoking Focused, 4 sessions
design_group_type: Active Comparator
design_group_title: Nicotine Patches, Dual Focused, 1 session
design_group_type: Active Comparator
design_group_title: Nicotine Patches, Dual Focused, 4 sessions
design_group_type: Active Comparator
design_group_title: Nicotine Patches, Smoking Focused, 1 session
design_group_type: Active Comparator
design_group_title: Nicotine Patches, Smoking Focused, 4 sessions
design_group_type: Active Comparator
Sponsor: University of Wisconsin-Madison
Collaborators: National Cancer Institute
Drug name mappings:
name: 尼古丁
lang: CN
name: Nicotine
lang: EN
name: 酒石酸伐尼克兰
lang: CN
name: Varenicline Tartrate
lang: EN
name: バレニクリン酒石酸塩
lang: JP