The Avenues Study: Dual Use Cessation

PHASE4RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

September 24, 2024

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Smoking CessationElectronic Cigarette Use
Interventions
DRUG

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

DRUG

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.

BEHAVIORAL

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).

BEHAVIORAL

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).

OTHER

Counseling Intensity: 1 Session

Participants assigned to one session will complete a single, 15-20 minute, session at Visit 2 (1 week pre-TQD).

OTHER

Counseling Intensity: 4 Sessions

Participants assigned to intensive counseling will have four, 15-20-minute sessions.

Trial Locations (1)

53792

RECRUITING

University of Wisconsin-Madison School of Medicine and Public Health, Madison

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Wisconsin, Madison

OTHER

NCT06474299 - The Avenues Study: Dual Use Cessation | Biotech Hunter | Biotech Hunter