iCanQuit App + Nicotine Therapy for Smoking Cessation

Overseen By Jonathan Bricker, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fred Hutchinson Cancer Center

Must not be taking: Warfarin

Disqualifiers: Heart attack, Stroke, Arrhythmia, Hypertension, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Hispanic adults quit smoking by testing a smartphone app that offers personalized quit plans, motivation tips, and tools to manage urges. It also examines whether adding nicotine replacement therapy (NRT), such as gum, lozenges, or patches, enhances the app's effectiveness. Individuals who have smoked at least one cigarette a day in the past month and wish to quit within the next 30 days may qualify, provided they have a smartphone and are not currently using other quitting aids. Participants will be randomly assigned to use the app alone or with NRT and will receive support for 12 months. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking smoking cessation method.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using other smoking cessation interventions or if you are using warfarin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the iCanQuit app helps people quit smoking and is user-friendly. Studies have found that app users quit smoking more often than those using other methods, with no major safety issues reported.

Nicotine Replacement Therapy (NRT), including products like the patch, gum, and lozenge, is also safe and easy to use. These products provide small amounts of nicotine to help control cravings and withdrawal symptoms without the harmful chemicals in tobacco. The FDA has approved NRT, and it has been shown to nearly double the chances of quitting smoking successfully.

Both the iCanQuit app and NRT are considered safe for helping people quit smoking, with no major problems reported in studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the iCanQuit app combined with nicotine replacement therapy (NRT) because it offers a new, tech-driven approach to smoking cessation. Unlike traditional methods that rely solely on nicotine patches, gum, or lozenges, the iCanQuit app provides personalized quit plans, education on managing urges, and relapse prevention strategies. Additionally, it includes on-demand support and tracking of cigarette consumption, along with daily reminders for NRT use. This integrated tech and therapy approach aims to enhance motivation and adherence, which could lead to better long-term success in quitting smoking.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research has shown that the iCanQuit smartphone app, which participants in this trial may receive, can help people stop smoking. One study found that app users were 1.49 times more likely to quit smoking than those using a different app. After 12 months, 28.2% of iCanQuit users reported not smoking for 30 days, marking a significant outcome. For nicotine replacement therapy (NRT), another treatment option in this trial, using a nicotine patch with gum or lozenges increases the chances of quitting. While NRT alone has mixed results, combining these methods helps more people quit smoking. Together, the app and NRT may enhance the chances of successfully quitting smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan Bricker, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for Hispanic adults who want to quit smoking and are willing to use a smartphone app designed to help with quitting. Participants must be comfortable using the iCanQuit app, which includes managing urges and creating personalized quit plans. There's no mention of specific exclusions in the provided information.

Inclusion Criteria

No household or family member participating

I am willing to attend follow-up assessments at 3, 6, and 12 months.

Self-identify as Hispanic ethnicity

Exclusion Criteria

I have not had a heart attack in the last 2 months.

My blood pressure is not well-controlled.

I have been diagnosed with an irregular or fast heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the iCanQuit smartphone application for 12 months, with personalized quit plans and education on managing urges, motivation, and relapse prevention. Arm II participants also receive NRT patches and gum or lozenges.

12 months

Follow-up

Participants are monitored for smoking cessation outcomes and cost-effectiveness measures at 12 months post-randomization.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• iCanQuit Smartphone App Smoking Cessation Program
• Nicotine Gum
• Nicotine Lozenge
• Nicotine Patch

Trial Overview The study is testing if the iCanQuit smartphone app helps people stop smoking when used alone or combined with nicotine replacement therapies like gum, patches, or lozenges. The goal is to see if these methods can ease cravings and withdrawal symptoms more effectively than just the app.

How Is the Trial Designed?

Group I: Arm II (iCanQuit application and NRT) Experimental Treatment 6 Interventions

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 II: Arm I (iCanQuit application) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study involving 1251 adult smokers, combining varenicline with a nicotine patch or extending varenicline treatment from 12 to 24 weeks did not significantly improve smoking cessation rates after 52 weeks.

The primary outcome of 7-day point prevalence abstinence was similar across all treatment groups, indicating that neither combination therapy nor longer treatment duration provided additional benefits for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. Baker, TB., Piper, ME., Smith, SS., et al.[2022]

Nicotine replacement therapy (NRT) significantly doubles quit rates for smoking cessation, especially when combined with behavioral therapy, and includes effective options like gum, patches, inhalers, and sprays.

NRT is generally safe for most patients with cardiovascular disease, but its use during pregnancy should be limited to heavy smokers who cannot quit, highlighting the need for careful consideration of patient safety in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine preparations and other preparations for smoking cessation]. Tonstad, S.[2015]

In a study involving 34 healthy adult smokers, tobacco-free oral nicotine pouches (NPs) showed similar nicotine absorption to lozenges and significantly better absorption than gum, indicating they may be an effective alternative for nicotine delivery.

Participants reported higher satisfaction with NPs compared to lozenges, and NPs had a lower incidence of minor adverse events, suggesting they are a well-tolerated option for smokers seeking nicotine replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. Azzopardi, D., Ebajemito, J., McEwan, M., et al.[2022]

Nicotine gum has been shown to improve long-term quit rates for smokers in several randomized, double-blind, placebo-controlled trials, indicating its efficacy as a smoking cessation aid.

The gum's effectiveness is primarily attributed to its ability to relieve withdrawal symptoms, but successful use also relies on proper instructions and additional support therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine gum to help stop smoking. Hughes, JR., Miller, SA.[2016]

Nicotine replacement therapies (NRTs) significantly increase the chances of quitting smoking, with an overall odds ratio of 1.71 based on a review of 53 trials involving 17,703 patients.

Among different NRT forms, the transdermal patch and inhaled nicotine showed the highest effectiveness, with odds ratios of 2.07 and 3.05 respectively, indicating that these methods may be particularly beneficial for smokers trying to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

In a clinical trial with 1818 smokers, the nicotine polacrilex lozenge demonstrated significant efficacy for smoking cessation, achieving 28-day abstinence rates of 46.0% for the 2-mg dose and 48.7% for the 4-mg dose compared to much lower rates in placebo groups.

The lozenge not only helped smokers quit but also reduced cravings and withdrawal symptoms, with most side effects being moderate and similar to those experienced with nicotine gum, indicating it is a safe option for both low- and high-dependence smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine lozenge for smoking cessation. Shiffman, S., Dresler, CM., Hajek, P., et al.[2022]

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Medicinal nicotine has significantly improved smoking cessation rates over the past 20 years, with various products like patches, gum, and inhalers available to help smokers quit.

Innovative nicotine delivery methods, such as high-dose patches and new forms like drinks and lollipops, are being developed to enhance cessation success and manage withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. Shiffman, S., Fant, RV., Buchhalter, AR., et al.[2015]

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

Varenicline is the most effective first-line pharmacotherapy for smoking cessation, showing a significant effect compared to placebo with an odds ratio of 2.27, followed by bupropion (1.69) and nicotine replacement therapy (1.60).

Despite some safety concerns, regulatory agencies deem bupropion and varenicline to have a favorable benefit/risk profile, but healthcare providers should monitor patients for potential neuropsychiatric symptoms, especially in those with psychiatric comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. Aubin, HJ., Luquiens, A., Berlin, I.[2022]

In a study involving over 6,000 smokers, nicotine replacement therapies (gum and patch) showed higher smoking cessation rates in over-the-counter (OTC) settings compared to prescription (Rx) settings, particularly at 6 weeks.

At 6 weeks, 16.1% of OTC gum users and 19.0% of OTC patch users achieved abstinence, compared to only 7.7% and 16.0% for Rx users, respectively, indicating that self-selection of doses in OTC settings may enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. Shiffman, S., Rolf, CN., Hellebusch, SJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2834192/

Nicotine Patch vs. Nicotine Lozenge for Smoking Cessation However, only 20-25% of smokers who use transdermal nicotine or nicotine lozenges report abstinence 6-months after a quit date (Shiffman et al., 2002a; Stead et ...

2. academic.oup.com academic.oup.com/ntr/article/27/10/1695/8129442

Effectiveness of Nicotine Replacement Therapy and ... The abstinence rate decreased from 62.4% to 47.3% at the end of the study. This reflects a reduced quit rate with increased time and follow-ups. The abstinence ...

3. tobaccopreventioncessation.com tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.html

The effectiveness of nicotine replacement therapy on oral ... A previous systematic review found that nicotine patches or gum did not receive much evidence to help individuals abstain from using smokeless ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2025.1525510/full

Nicotine replacement therapy as a smoking cessation tool ... Results: NRT demonstrated limited success in long-term smoking cessation among adolescents, with low cessation rates that often declined post- ...

5. evidence.nihr.ac.uk evidence.nihr.ac.uk/alert/using-both-nicotine-patches-and-gum-together-improves-the-chances-of-quitting-smoking/

Using both nicotine patches and gum together improves ... Using a nicotine patch together with a fast-acting type of nicotine replacement therapy (NRT) such as gum or lozenges improves smoking cessation rates.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK493148/

Nicotine Replacement Therapy - StatPearls - NCBI Bookshelf NRTs are designed to replicate the nicotine response typically experienced through smoking, thereby helping individuals manage cravings and withdrawal symptoms.

7. cancer.org cancer.org/cancer/risk-prevention/tobacco/guide-quitting-smoking/nicotine-replacement-therapy.html

Nicotine Replacement Therapy to Help You Quit Tobacco Many studies have shown using NRT can almost double the chances of quitting smoking. It hasn't been studied as much for quitting smokeless ...

8. cdc.gov cdc.gov/tobacco/campaign/tips/quit-smoking/quit-smoking-medications/how-to-use-quit-smoking-medicines/how-to-use-the-nicotine-lozenge.html

How to Use Nicotine Lozenges | Quit Smoking The nicotine lozenge is an FDA-approved medicine that can help people quit smoking. It can be used every 1-2 hours by itself to control withdrawal symptoms (up ...

9. fda.gov fda.gov/media/167599/download

Developing Nicotine Replacement Therapy Drug Products an NRT gum product for smoking cessation could involve a new18 ... other smoking cessation drugs and any non-study nicotine or tobacco products should be.

10. wakehealth.edu wakehealth.edu/-/media/wakeforest/clinical/files/cancer/oche/community-tobacco-group---session-3-pdf.pdf

Nicotine Replacement Therapy Getting nicotine from the patch, gum or lozenge is safe. Using cigarettes, e-cigarettes (such as JUUL), or chewing tobacco/snuff is not safe.