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

854 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the iCanQuit App + Nicotine Therapy treatment for smoking cessation?

Research shows that nicotine replacement therapies like patches, gum, and lozenges help many people quit smoking. Combining different nicotine therapies, such as a patch with another form, may be even more effective. This suggests that using the iCanQuit App along with nicotine products could help people stop smoking. ^{1 2 3 4 5}

Is the iCanQuit App + Nicotine Therapy safe for humans?

Nicotine replacement therapies like gum, lozenges, and patches are generally safe for most people, including those with heart conditions, but should be used cautiously during pregnancy. These therapies are well-tolerated, with minor side effects reported, and are effective in helping people quit smoking. ^{5 6 7 8 9}

How does the iCanQuit App + Nicotine Therapy treatment differ from other smoking cessation treatments?

The iCanQuit App + Nicotine Therapy is unique because it combines digital support through an app with traditional nicotine replacement therapies like gum, lozenges, and patches, potentially enhancing motivation and support for quitting smoking. This approach integrates behavioral support with pharmacological intervention, which may improve quit rates compared to using nicotine replacement alone. ^{1 5 7 10 11}

What is the purpose of this trial?

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.

Research Team

Jonathan Bricker, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. [2022]

7. Norway pubmed.ncbi.nlm.nih.gov

[Nicotine preparations and other preparations for smoking cessation]. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Nicotine gum to help stop smoking. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a nicotine lozenge for smoking cessation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. [2022]