iCanQuit Smoking Cessation Among Hispanic Adults

NCT ID: NCT06811038

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

854 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2030-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.

ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.

After completion of study intervention, patients may be followed up at 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cigarette Smoking-Related Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
To assure blinding, random assignments will be concealed from participants and researchers throughout the trial. Follow-up data will be collected by our survey research unit that will be blind to treatment arm

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I (iCanQuit application)

Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking.

Group Type EXPERIMENTAL

iCanQuit Smartphone App Smoking Cessation Program

Intervention Type DEVICE

Receive access to iCanQuit app, with daily push notifications

Survey Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Arm II (iCanQuit application and NRT)

Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months.

Group Type EXPERIMENTAL

iCanQuit Smartphone App Smoking Cessation Program

Intervention Type DEVICE

Receive access to iCanQuit app, with daily push notifications

Nicotine Gum

Intervention Type DRUG

Receive nicotine replacement therapy gum

Nicotine Patch

Intervention Type DRUG

Receive nicotine replacement therapy patch(es)

Nicotine Lozenge

Intervention Type DRUG

Receive nicotine replacement therapy lozenge(s)

Survey Administration

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iCanQuit Smartphone App Smoking Cessation Program

Receive access to iCanQuit app, with daily push notifications

Intervention Type DEVICE

Nicotine Gum

Receive nicotine replacement therapy gum

Intervention Type DRUG

Nicotine Patch

Receive nicotine replacement therapy patch(es)

Intervention Type DRUG

Nicotine Lozenge

Receive nicotine replacement therapy lozenge(s)

Intervention Type DRUG

Survey Administration

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

iCanQuit Nicorette Nicotine Polacrilex gum NicoDerm CQ Nicotine Skin Patch Nicotine Transdermal Patch Nicorette mini lozenge Nicotine Polacrilex lozenge

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jonathan Bricker, PhD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jonathan Bricker, PhD

Role: CONTACT

Phone: 206-667-5074

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jonathan Bricker, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2024-10014

Identifier Type: REGISTRY

Identifier Source: secondary_id

20697

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA298383

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1124868

Identifier Type: -

Identifier Source: org_study_id