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Taking people in United StatesPhase 4

The Avenues Study: Dual Use Cessation

Key facts

Who runs it
University of Wisconsin, Madison
Where
Madison, United StatesSee the site
Trial code
Status
Recruiting
Phase
Phase 4
People taking part
500 people, planned
Started
24 Sept 2024
Expected to end
Jul 2028
Type of study
Interventional, 8 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Varenicline
  • Nicotine patch
  • Dual Focused Cessation Counseling
  • Smoking Focused Cessation Counseling
  • Counseling Intensity: 1 Session
  • Counseling Intensity: 4 Sessions
Record updated
7 October 2026

Who can take part

Age
21 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 >30 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

Who cannot take part

  • 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
  • Currently in treatment for psychosis or bipolar disorder

Where in United States

  • University of Wisconsin-Madison School of Medicine and Public HealthMadison, United StatesContact: Mark ZehnerTaking people

About the trial

What the trial wants to find out

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.

The 8 groups in the trial

  • Varenicline, Dual Focused, 1 sessionExisting treatment, for comparison

    Treatment: Varenicline, Dual Focused Cessation Counseling, and Counseling Intensity: 1 Session

  • Varenicline, Dual Focused, 4 sessionsExisting treatment, for comparison

    Treatment: Varenicline, Dual Focused Cessation Counseling, and Counseling Intensity: 4 Sessions

  • Varenicline, Smoking Focused, 1 sessionExisting treatment, for comparison

    Treatment: Varenicline, Smoking Focused Cessation Counseling, and Counseling Intensity: 1 Session

  • Varenicline, Smoking Focused, 4 sessionsExisting treatment, for comparison

    Treatment: Varenicline, Smoking Focused Cessation Counseling, and Counseling Intensity: 4 Sessions

  • Nicotine Patches, Dual Focused, 1 sessionExisting treatment, for comparison

    Treatment: Nicotine patch, Dual Focused Cessation Counseling, and Counseling Intensity: 1 Session

  • Nicotine Patches, Dual Focused, 4 sessionsExisting treatment, for comparison

    Treatment: Nicotine patch, Dual Focused Cessation Counseling, and Counseling Intensity: 4 Sessions

  • Nicotine Patches, Smoking Focused, 1 sessionExisting treatment, for comparison

    Treatment: Nicotine patch, Smoking Focused Cessation Counseling, and Counseling Intensity: 1 Session

  • Nicotine Patches, Smoking Focused, 4 sessionsExisting treatment, for comparison

    Treatment: Nicotine patch, Smoking Focused Cessation Counseling, and Counseling Intensity: 4 Sessions

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Record updated
7 October 2026