Cigarette Smoking-Related CarcinomaPhase 3NCT06811038
iCanQuit Smoking Cessation Among Hispanic Adults
A Phase 3 study testing iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum and Nicotine Patch in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum and Nicotine Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 854 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jonathan Bricker, PhD, 206-667-5074, jbricker@fredhutch.org
Jonathan Bricker, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum, Nicotine Patch, Nicotine Lozenge, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCanQuit Smartphone App Smoking Cessation ProgramDevice
Also called iCanQuit
Receive access to iCanQuit app, with daily push notifications
Nicotine GumDrug
Also called Nicorette, Nicotine Polacrilex gum
Receive nicotine replacement therapy gum
Nicotine PatchDrug
Also called NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal Patch
Receive nicotine replacement therapy patch(es)
Nicotine LozengeDrug
Also called Nicorette, mini lozenge, Nicotine Polacrilex lozenge
Receive nicotine replacement therapy lozenge(s)
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: iCanQuit Smartphone App Smoking Cessation Program; Drug: Nicotine Gum; Drug: Nicotine Patch; Drug: Nicotine Lozenge; Other: Survey Administration; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months post randomization
Secondary outcomes (6)
30-day PPA
Measured: At 3 and 6 months post randomization
24 hour PPA
Measured: At 3, 6 and 12 months post randomization
7 day PPA
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 854 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jonathan Bricker, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811038
- Sponsor's protocol ID
- RG1124868
- Other IDs
- NCI-2024-10014, 20697, R01CA298383
- Status last verified
- Jun 2026
- First submitted
- 31 Jan 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults
- ClinicalTrials.gov ID
- NCT06811038
- Acronym / sponsor ID
- RG1124868
- Conditions
- Cigarette Smoking-Related Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 854 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (iCanQuit application) | Experimental | Device: iCanQuit Smartphone App Smoking Cessation Program, Other: Survey Administration, Other: InterviewParticipants 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 (iCanQuit application and NRT) | Experimental | Device: iCanQuit Smartphone App Smoking Cessation Program, Drug: Nicotine Gum, Drug: Nicotine Patch, Drug: Nicotine Lozenge, Other: Survey Administration, Other: InterviewParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCanQuit Smartphone App Smoking Cessation ProgramAlso: iCanQuitReceive access to iCanQuit app, with daily push notifications | Device | Arm I (iCanQuit application), Arm II (iCanQuit application and NRT) |
| Nicotine GumAlso: Nicorette, Nicotine Polacrilex gumReceive nicotine replacement therapy gum | Drug | Arm II (iCanQuit application and NRT) |
| Nicotine PatchAlso: NicoDerm CQ, Nicotine Skin Patch, Nicotine Transdermal PatchReceive nicotine replacement therapy patch(es) | Drug | Arm II (iCanQuit application and NRT) |
| Nicotine LozengeAlso: Nicorette, mini lozenge, Nicotine Polacrilex lozengeReceive nicotine replacement therapy lozenge(s) | Drug | Arm II (iCanQuit application and NRT) |
| Survey AdministrationAncillary studies | Other | Arm I (iCanQuit application), Arm II (iCanQuit application and NRT) |
| InterviewAncillary studies | Other | Arm I (iCanQuit application), Arm II (iCanQuit application and NRT) |
Primary outcome
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.
6 secondary outcomes
30-day PPA
Time frame: At 3 and 6 months post randomization
24 hour PPA
Time frame: At 3, 6 and 12 months post randomization
7 day PPA
Time frame: At 3, 6 and 12 months post randomization
Cost per quitter
Time frame: At 12 months post randomization
Cost per life year gained
Time frame: At 12 months post randomization
Cost per quality-adjusted life year (QALY) gained
Time frame: At 12 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Bricker, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iCanQuit Smartphone App Smoking Cessation Program, Nicotine Gum and Nicotine Patch in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Bricker, PhD (206-667-5074, jbricker@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day point prevalence abstinence (PPA) (time frame: At 12 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.