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Can a pill and patch help dual users kick the smoking habit?

NCT ID NCT06474299

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of varenicline (a pill) and nicotine patches can help people who both smoke cigarettes and use e-cigarettes quit smoking. About 500 participants will take the medications and be followed for 12 months to see if they stay smoke-free. The goal is to find the most effective approach for this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
varenicline and nicotine patches
What this could lead to
If successful, this could identify the best combination of medications to help dual users quit smoking, reducing their health risks.
What could go wrong
This is a Phase 4 screening trial, so results are preliminary. The interventions may not work for everyone, and side effects like nausea or skin irritation are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Smoking Cessation Vaping

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Electronic cigarette use Smoking cessation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Wisconsin-Madison School of Medicine and Public Health

    RECRUITING

    Madison, Wisconsin, 53792, United States

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