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Can a smartphone app and nicotine lozenges boost quit rates?

NCT ID NCT07099638

Symptom relief Sponsor: University of Oklahoma 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 4 times

Summary

This study tests whether adding nicotine lozenges to standard smoking-cessation medication (varenicline) and using a smartphone app with medication reminders helps more people quit smoking. About 500 adults who smoke daily will be randomly assigned to different treatment combinations. The main goal is to see who stays smoke-free 6 months after their quit date.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 496 people

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

Started

Jul 2026

Expected to finish

Jun 2029

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

18 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: * Able to provide documentation of identity (to prevent fraudulent enrollment) and Oklahoma residence (due to limitations on prescribing to out-of-state residents) * Reports daily smoking ≥5 cigarettes per day * Provides a breath CO sample ≥6ppm to verify current smoking * Willing to schedule a smoking cessation attempt within the next 1-2 weeks * Willing to abstain from smoking cannabis or other combustible products during the study * Willing to use varenicline and nicotine lozenges * Willing to participate in the study for ≈6 months * Able to demonstrate \>6th grade literacy which is necessary to read intervention materials and complete study assessments Exclusion Criteria: * Does not own a smartphone that is compatible with the study app * Using an FDA-approved smoking cessation medication within the past 30 days * Using oral nicotine products (e.g., pouches, chewing tobacco, snus) more than once per week (5+ times) during the past 30 days * History of seizures (varenicline contraindication) * History of allergic reaction to varenicline * Pregnant, planning to become pregnant, or currently breastfeeding * Unwilling or unable to use varenicline or nicotine lozenges for other reasons (e.g., severe dry mouth, past history of severe medication side effects) * Other medical reasons at the discretion of the prescribing physician (e.g., uncontrolled hypertension, recent myocardial infarction) * Weekly or more frequent use of combustible cannabis during the past 30 days with a score ≥2 on the Cannabis Use Disorder Identification Test-Short Form

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Conditions

The condition(s) this trial relates to.

Medication Adherence Smoking Cessation

As listed by the trial registrant

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

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

  • TSET Health Promotion Research Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

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