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NCT Number: NCT06811038

iCanQuit Smoking Cessation Among 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.

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Jonathan Bricker, PhD

CONTACT

[email protected]

206-667-5074

Jonathan Bricker, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCanQuit Smartphone App Smoking Cessation Program

Device

Receive access to iCanQuit app, with daily push notifications

Other names: iCanQuit

Nicotine gum

Drug

Receive nicotine replacement therapy gum

Other names: Nicorette, Nicotine Polacrilex gum

Nicotine patch

Drug

Receive nicotine replacement therapy patch(es)

Other names: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch

Nicotine Lozenge

Drug

Receive nicotine replacement therapy lozenge(s)

Other names: Nicorette, mini lozenge, Nicotine Polacrilex lozenge

Survey Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Primary outcomes

  1. 30-day point prevalence abstinence (PPA)

    Time frame: At 12 months post randomization

    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.

Secondary outcomes

  1. 30-day PPA

    Time frame: At 3 and 6 months post randomization

  2. 24 hour PPA

    Time frame: At 3, 6 and 12 months post randomization

  3. 7 day PPA

    Time frame: At 3, 6 and 12 months post randomization

  4. Cost per quitter

    Time frame: At 12 months post randomization

    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.

  5. Cost per life year gained

    Time frame: At 12 months post randomization

    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.

  6. Cost per quality-adjusted life year (QALY) gained

    Time frame: At 12 months post randomization

    Standard methods for estimating cost-effectiveness in smoking cessation interventions will be used. Will estimate cost-per-QALY gained.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Bricker, PhD

CONTACT

[email protected]

206-667-5074

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 6, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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