Helping dual users of cigarettes and e-cigarettes quit smoking
Official title: Dual Use Cessation: A MOST Screening Trial to Identify Effective Interventions to Help People Who Smoke and Vape
Run by University of Wisconsin, Madison · NCT06474299 · Data updated 2026-11-12
This study is testing different ways to help people who smoke both cigarettes and e-cigarettes quit for good by using medications and counseling.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Status | Recruiting |
| Started | September 24, 2024 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT06474299 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who smoke at least 5 cigarettes per day and vape weekly, and are motivated to quit smoking within the next 30 days.
✕Probably not a fit
Patients who are currently pregnant, breastfeeding, or have untreated psychosis or bipolar disorder may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This research aims to identify the most effective methods for assisting individuals who use both cigarettes and electronic nicotine delivery systems (ENDS) in quitting smoking. The study will enroll 500 participants and utilize a randomized factorial design to test various combinations of pharmacotherapy and counseling approaches. Participants will receive either varenicline or nicotine patches, along with counseling that varies in intensity and focus. The goal is to optimize interventions that encourage quitting both smoking and vaping.
Why it matters
Potential benefit: If successful, this study could provide a more effective approach for dual users to quit smoking and improve their overall health.
How similar studies have gone: Other studies have shown promise in using combined pharmacotherapy and counseling approaches for smoking cessation, making this a potentially effective strategy.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where it's running
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University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, United States Recruiting
Study contacts
- Principal investigator: Megan E Piper, PhD — University of Wisconsin, Madison
- Study coordinator: Mark Zehner
- Email: mark.zehner@wisc.edu
- Phone: 608-262-7568
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.