Recruiting

Dual Use Cessation

Sponsor:

University of Wisconsin, Madison

Code:

NCT06474299

Conditions

Smoking Cessation

Electronic Cigarette Use

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Varenicline

Nicotine patch

Dual Focused Cessation Counseling

Smoking Focused Cessation Counseling

Counseling Intensity: 1 Session

Study Details

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

Study ID

NCT06474299

Start date

Sep 24, 2024

Status verified date

Apr, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 >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

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Varenicline, Dual Focused, 1 session

active comparator: Varenicline, Dual Focused, 4 sessions

active comparator: Varenicline, Smoking Focused, 1 session

active comparator: Varenicline, Smoking Focused, 4 sessions

active comparator: Nicotine Patches, Dual Focused, 1 session

active comparator: Nicotine Patches, Dual Focused, 4 sessions

active comparator: Nicotine Patches, Smoking Focused, 1 session

active comparator: Nicotine Patches, Smoking Focused, 4 sessions

Interventions

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

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.

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).

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).

Counseling Intensity: 1 Session

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

Counseling Intensity: 4 Sessions

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

Primary outcome measure

  • 52-week biochemically confirmed 7-day point-prevalence abstinence from cigarettes [ Time Frame: up to 52 weeks ]

Central Contacts and Locations

Central contacts

Mark Zehner

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

Locations

University of Wisconsin-Madison School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Mark Zehner

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

Principal Investigator:

Megan Piper, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • ENDS
  • Cessation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-04-13.