iCanQuit Smoking Cessation Among Hispanic Adults

NCT06811038 | Not Yet Recruiting Phase 3 FDA Drug FDA Device

• 4 other identifiers: RG1124868NCI-2024-1001420697R01CA298383
• Study Type: interventional
• Target: 854
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  At 12 months post randomization

• Cost per life year gained

  At 12 months post randomization

Study Arms (2)

Arm I (iCanQuit application)

EXPERIMENTAL

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.

Device: iCanQuit Smartphone App Smoking Cessation Program; Other: Survey Administration; Other: Interview

Arm II (iCanQuit application and NRT)

EXPERIMENTAL

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.

Device: iCanQuit Smartphone App Smoking Cessation Program; Drug: Nicotine Gum; Drug: Nicotine Patch; Drug: Nicotine Lozenge; Other: Survey Administration; Other: Interview

Interventions

Nicotine Patch DRUG

Receive nicotine replacement therapy patch(es)

Also known as: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Arm II (iCanQuit application and NRT)

Nicotine Gum DRUG

Receive nicotine replacement therapy gum

Also known as: Nicorette, Nicotine Polacrilex gum

Arm II (iCanQuit application and NRT)

Nicotine Lozenge DRUG

Receive nicotine replacement therapy lozenge(s)

Also known as: Nicorette, mini lozenge, Nicotine Polacrilex lozenge

Arm II (iCanQuit application and NRT)

Survey Administration OTHER

Ancillary studies

Arm I (iCanQuit application); Arm II (iCanQuit application and NRT)

iCanQuit Smartphone App Smoking Cessation Program DEVICE

Receive access to iCanQuit app, with daily push notifications

Also known as: iCanQuit

Arm I (iCanQuit application); Arm II (iCanQuit application and NRT)

Interview OTHER

Ancillary studies

Arm I (iCanQuit application); Arm II (iCanQuit application and NRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Nicotine Chewing Gum; Tobacco Use Cessation Devices; Nicotine; Interviews as Topic

Intervention Hierarchy (Ancestors)

Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jonathan Bricker, PhD

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Bricker, PhD

CONTACT

206-667-5074; jbricker@fredhutch.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)