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Can an app plus nicotine gum help hispanic smokers kick the habit?

NCT ID NCT06811038

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 3 times

Summary

This phase III trial will enroll 854 Hispanic adults who smoke and want to quit. Participants will use the iCanQuit smartphone app, which teaches skills to manage cravings and prevent relapse. Half will also receive nicotine replacement therapy (gum, patch, or lozenge) to ease withdrawal. The study aims to see if adding NRT boosts quit rates compared to the app alone.

What this could mean

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

Active substance
Nicotine replacement therapy (gum, patch, lozenge) and a smartphone app (iCanQuit)
What this could lead to
If successful, this could provide an effective, scalable smoking cessation program tailored for Hispanic adults, reducing smoking-related diseases.
What could go wrong
This is a large trial, but results depend on participants sticking with the app and NRT. The benefit may be modest, and long-term abstinence is hard to maintain.

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 854 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

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: * Self-identify as Hispanic ethnicity * Age 18 and older * Smoking at least one cigarette per day in the past 30 days * Want to quit smoking within 30 days * Interest in learning skills to quit smoking * Willing to be randomly assigned * United States (US) or Puerto Rico (PR) residency for the next twelve months * Have daily access to their own Android or iPhone smartphone * Ability to download a smartphone application (app) * Proficiency in English or Spanish * Not currently (i.e., within past 30 days) using other smoking cessation interventions * Willing to consider using NRT * No previous use of iCanQuit * No household or family member participating * Willingness to complete follow-up assessments at the 3-, 6-, and 12-month follow-ups * Providing email, phone number(s), and mailing address Exclusion Criteria: * NRT CONTRAINDICATION: Heart attack in the last 2 months * NRT CONTRAINDICATION: Stroke in the last 6 months * NRT CONTRAINDICATION: Diagnosed arrhythmia or tachycardia * NRT CONTRAINDICATION: Uncontrolled hypertension * NRT CONTRAINDICATION: Currently using warfarin * NRT CONTRAINDICATION: Pregnant or breastfeeding, or plans to become pregnant during the next 6 months

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109, United States

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