The Avenues Study: Dual Use Cessation

NCT06474299 | Recruiting Phase 4 FDA Drug

• 5 other identifiers: 2024-0019R01CA290895A534253SMPH/MEDICINE/GEN INT MDProtocol Version 12/12/2025
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Electronic Cigarette Use

Keywords

ENDS; Cessation

Outcome Measures

Primary Outcomes (1)

• 52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

  52-week biochemically confirmed (anabasine\<2 ng/ml) 7-day point-prevalence abstinence from cigarettes

  up to 52 weeks

Secondary Outcomes (2)

• 26-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

  up to 26 weeks

• 7-day point-prevalence abstinence from smoking and vaping at Weeks 26 and 52 post-TQD

  up to 52 weeks

Other Outcomes (6)

• Number of Participants Achieving Initial Smoking Abstinence

  up to 2 weeks

• 12-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes

  up to 12 Weeks (end of treatment)

• 7-day point-prevalence abstinence from smoking and vaping at Week 12

  up to 12 Weeks (end of treatment)

Study Arms (8)

Varenicline, Dual Focused, 1 session

ACTIVE COMPARATOR

Drug: Varenicline; Behavioral: Dual Focused Cessation Counseling; Other: Counseling Intensity: 1 Session

Varenicline, Dual Focused, 4 sessions

ACTIVE COMPARATOR

Drug: Varenicline; Behavioral: Dual Focused Cessation Counseling; Other: Counseling Intensity: 4 Sessions

Varenicline, Smoking Focused, 1 session

ACTIVE COMPARATOR

Drug: Varenicline; Behavioral: Smoking Focused Cessation Counseling; Other: Counseling Intensity: 1 Session

Varenicline, Smoking Focused, 4 sessions

ACTIVE COMPARATOR

Drug: Varenicline; Behavioral: Smoking Focused Cessation Counseling; Other: Counseling Intensity: 4 Sessions

Nicotine Patches, Dual Focused, 1 session

ACTIVE COMPARATOR

Drug: Nicotine patch; Behavioral: Dual Focused Cessation Counseling; Other: Counseling Intensity: 1 Session

Nicotine Patches, Dual Focused, 4 sessions

ACTIVE COMPARATOR

Drug: Nicotine patch; Behavioral: Dual Focused Cessation Counseling; Other: Counseling Intensity: 4 Sessions

Nicotine Patches, Smoking Focused, 1 session

ACTIVE COMPARATOR

Drug: Nicotine patch; Behavioral: Smoking Focused Cessation Counseling; Other: Counseling Intensity: 1 Session

Nicotine Patches, Smoking Focused, 4 sessions

ACTIVE COMPARATOR

Drug: Nicotine patch; Behavioral: Smoking Focused Cessation Counseling; Other: Counseling Intensity: 4 Sessions

Interventions

Varenicline DRUG

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

Varenicline, Dual Focused, 1 session; Varenicline, Dual Focused, 4 sessions; Varenicline, Smoking Focused, 1 session; Varenicline, Smoking Focused, 4 sessions

Nicotine patch DRUG

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.

Nicotine Patches, Dual Focused, 1 session; Nicotine Patches, Dual Focused, 4 sessions; Nicotine Patches, Smoking Focused, 1 session; Nicotine Patches, Smoking Focused, 4 sessions

Dual Focused Cessation Counseling BEHAVIORAL

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).

Nicotine Patches, Dual Focused, 1 session; Nicotine Patches, Dual Focused, 4 sessions; Varenicline, Dual Focused, 1 session; Varenicline, Dual Focused, 4 sessions

Smoking Focused Cessation Counseling BEHAVIORAL

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).

Nicotine Patches, Smoking Focused, 1 session; Nicotine Patches, Smoking Focused, 4 sessions; Varenicline, Smoking Focused, 1 session; Varenicline, Smoking Focused, 4 sessions

Counseling Intensity: 1 Session OTHER

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

Nicotine Patches, Dual Focused, 1 session; Nicotine Patches, Smoking Focused, 1 session; Varenicline, Dual Focused, 1 session; Varenicline, Smoking Focused, 1 session

Counseling Intensity: 4 Sessions OTHER

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

Nicotine Patches, Dual Focused, 4 sessions; Nicotine Patches, Smoking Focused, 4 sessions; Varenicline, Dual Focused, 4 sessions; Varenicline, Smoking Focused, 4 sessions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read and communicate in English
• Willing to set a quit date to quit smoking cigarettes in the next 30 days
• Willing and medically able to use varenicline and nicotine patches
• Smoking ≥ 5 cigarettes per day for the past 6 months
• Vaping weekly for at least 6 months
• Willing to stop using nicotine replacement or varenicline
• Willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
• Saliva cotinine \>20 ng/ml
• US resident
• Own a Smartphone to use and download an app to record data
• have a working email so that they can receive links for video visits

You may not qualify if:

• Currently in treatment for psychosis or bipolar disorder
• If they are currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
• Currently pregnant or breastfeeding. If a participant becomes pregnant while in the study, they will be allowed to continue in the study but will no longer receive study medications. They will also be asked to return any unused study medications.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

Varenicline; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Therapeutics

Study Officials

• Megan E Piper, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Zehner

CONTACT

608-262-7568; mark.zehner@wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2x2 factorial screening trial

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: September 24, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)