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Can new E-Cigs and a pill help dual users kick cigarettes for good?

NCT ID NCT05703672

Disease control Sponsor: University of Kansas Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 4th-generation nicotine salt e-cigarette, combined with the drug varenicline, can help people who both smoke and vape reduce their exposure to harmful chemicals and quit regular cigarettes. Researchers will enroll 500 adults who smoke at least 5 cigarettes daily and are interested in switching to e-cigarettes. The goal is to see if this approach lowers cancer-causing toxins and leads to long-term cigarette abstinence.

What this could mean

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

Active substance
nicotine salt pod-based e-cigarette and varenicline
What this could lead to
If successful, this could provide a safer alternative for smokers who can't quit, reducing toxic exposure and helping them stop combustible cigarettes.
What could go wrong
This is a Phase 3 trial, but results may not apply to all smokers. Varenicline can cause side effects like nausea, and e-cigarettes still carry health risks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Jul 2023

Expected to finish

Feb 2027

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

Accepted

You do not need to have the condition being studied to take part.

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: * ≥ 21 years of age * Smoke \>5 cigarettes per day * Smoked cigarettes for \> 6 months * Verified smoker (CO \> 5 ppm) * Functioning telephone * Interested in switching to EC * Willing to take varenicline and complete all study visits Exclusion Criteria: * Interested in quitting smoking * Use of smoking cessation pharmacotherapy in the month prior to enrollment * Use of other tobacco products in past 30 days (i.e., cigarillos, cigars, hookah, smokeless tobacco, pipes) * EC use on \> 4 of the past 30 days * Uncontrolled hypertension: BP \> 180 (systolic) or \> 105 (diastolic) * Heart-related event in the past 30 days * Medical contraindications to VAR: unstable cardiac condition (e.g., unstable angina or AMI) cardiac event, or stroke in the past 4 weeks; renal impairment; history of clinically significant allergic reactions; history of epilepsy or seizure disorder; hospitalized for psychiatric issue in past 30 days; active suicidal ideation * Pregnant, contemplating getting pregnant, or breastfeeding * Plans to move from Kansas City metro area during the treatment and follow-up phase * Another household member enrolled in the study

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Conditions

The condition(s) this trial relates to.

Smoking Reduction

As listed by the trial registrant

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

Smoking reduction

How to take part

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

  1. The places running it

    2 sites. 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

  • Swope Health Central

    RECRUITING

    Kansas City, Missouri, 64130, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Missouri, 64130, United States

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