RecruitingPhase 4NCT06474299

The Avenues Study: Dual Use Cessation

Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape


Sponsor

University of Wisconsin, Madison

Enrollment

500 participants

Start Date

Sep 24, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Counseling Intensity: 1 Session, Counseling Intensity: 4 Sessions, and others for people with electronic cigarette use and smoking cessation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVarenicline

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

DRUGNicotine 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.

BEHAVIORALDual 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).

BEHAVIORALSmoking 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).

OTHERCounseling Intensity: 1 Session

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

OTHERCounseling 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

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NCT06474299


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