iCanQuit Smoking Cessation Among Hispanic Adults

Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Device: iCanQuit Smartphone App Smoking Cessation Program; Drug: Nicotine Gum; Drug: Nicotine Patch; Drug: Nicotine Lozenge

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 854
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jonathan Bricker, PhD; Phone Number: 206-667-5074; Email: jbricker@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Jonathan Bricker, PhD; Phone Number: 206-667-5074; Email: jbricker@fredhutch.org
      • Principal Investigator: Jonathan Bricker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Device: iCanQuit Smartphone App Smoking Cessation Program; Receive access to iCanQuit app, with daily push notifications; Other Names: iCanQuit
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Device: iCanQuit Smartphone App Smoking Cessation Program; Receive access to iCanQuit app, with daily push notifications; Other Names: iCanQuit; Drug: Nicotine Gum; Receive nicotine replacement therapy gum; Other Names: Nicorette; Nicotine Polacrilex gum; Drug: Nicotine Patch; Receive nicotine replacement therapy patch(es); Other Names: NicoDerm CQ; Nicotine Skin Patch; Nicotine Transdermal Patch; Drug: Nicotine Lozenge; Receive nicotine replacement therapy lozenge(s); Other Names: Nicorette; mini lozenge; Nicotine Polacrilex lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day point prevalence abstinence (PPA)	The comparison will use a logistic regression model, following standard intent-to-treat analysis for smoking cessation trials, will be employed, coding all missing outcomes as smoking. The model will adjust for stratification factors and baseline factors that are both imbalanced after randomization and significantly related to the outcome.	At 12 months post randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day PPA		At 3 and 6 months post randomization
24 hour PPA		At 3, 6 and 12 months post randomization
7 day PPA		At 3, 6 and 12 months post randomization
Cost per quitter	Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. The incremental cost-per-quitter will be estimated as the difference in total cost of delivering the two interventions divided by the difference in the number of 30-day abstinent participants at 12 months.	At 12 months post randomization
Cost per life year gained	Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. To compare iCanQuit with iCanQuit plus NRT in terms of life years gained, researchers will calculate the cost per life year gained.	At 12 months post randomization
Cost per quality-adjusted life year (QALY) gained	Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained.	At 12 months post randomization

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jonathan Bricker, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Care Quality, Access, and Evaluation; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carbohydrates; Alkaloids; Polymers; Macromolecular Substances; Polysaccharides; Biopolymers; Plant Gums; Candy; Solanaceous Alkaloids; Chewing Gum; Nicotine; Interviews as Topic; Tobacco Use Cessation Devices; Nicotine Chewing Gum
• Other Study ID Numbers: RG1124868; NCI-2024-10014 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 20697 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R01CA298383 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial results data will be published on ClinicalTrials.gov at the time of study completion. The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified scientific data will be made available as public use data to the research community in openICPSR. Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads. No PII or PHI data will be shared or available for secondary use. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
• IPD Sharing Time Frame: The trial results data will be published on ClinicalTrials.gov at the time of study completion. The de-identified scientific data will be made available to other users no later than the time of publication of the primary outcomes, or at the end of the performance period, whichever comes first. The de-identified data deposited in openICPSR will be available to the research community in perpetuity.
• IPD Sharing Access Criteria: The de-identified scientific data will be made available as public use data to the research community in openICPSR. Members of the research community using this data must register with ICPSR and agree to the Terms of Use, which include limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, requiring immediate reporting of any disclosure of participant identity, and requiring users agree not to share or redistribute any data downloads. No PII or PHI data will be shared or available for secondary use.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes