Smartphone App + Nicotine Patches for Smoking Cessation

Overseen By Yong Cui, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Psychotropics, Anticonvulsives, Narcotics

Disqualifiers: Depression, Suicidality, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a smartphone app, combined with nicotine patches, can help people quit smoking. Researchers seek to understand users' experiences with the app and its effectiveness in reducing smoking. Participants will use the app to follow a smoking schedule and record their smoking habits for up to three months. This trial is open to individuals who smoke at least 10 cigarettes a day, are interested in quitting, and can use an Android smartphone. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could assist others in quitting smoking.

Will I have to stop taking my current medications?

The trial requires participants to stop using marijuana, prescription medications not prescribed to them, and illegal drugs. If you are taking psychotropic, anticonvulsive, or narcotic medication, you cannot participate in the trial.

What prior data suggests that this smartphone app and nicotine patches are safe for smoking cessation?

Research shows that nicotine patches, such as Nicoderm CQ, are generally safe and effective for helping people quit smoking. They release a small, steady amount of nicotine through the skin, reducing cravings and withdrawal symptoms. Studies indicate that the risk of side effects from nicotine patches is low, making them a safer option than smoking.

Research suggests that the smartphone app can also aid in quitting smoking. Many users have successfully stopped smoking with its help. Although the app's safety hasn't been specifically studied, smoking cessation apps are generally considered safe and can complement nicotine patches. Together, they offer a well-tolerated approach to support quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines a smartphone app with nicotine patches to tackle smoking cessation. Unlike standard methods that rely solely on nicotine replacement therapies like patches or gums, this approach uses a digital tool to actively guide and track smoking reduction. The app provides a structured smoking schedule and requires participants to log their smoking habits and complete online surveys, potentially offering a more personalized and engaging way to quit smoking. By integrating technology with traditional treatment, this method aims to enhance adherence and success rates in quitting smoking, which is a novel approach in the field.

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

Research has shown that smartphone apps can help people quit smoking. Studies have found that individuals using these apps are more likely to quit than those without any support. For example, one study found that app users were 1.49 times more likely to quit. In this trial, participants will use a smartphone app designed to aid smoking cessation. Using these apps with nicotine patches, already known to reduce cravings, may further improve the chances of quitting. Quitting smoking greatly reduces the risk of early death, making these tools a promising option for those who want to quit. ^{6 7 8 9 10}

Who Is on the Research Team?

Yong Cui, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults who smoke at least 10 cigarettes or similar products daily, want to quit smoking, and are willing to use a smartphone app with nicotine patches. They must speak English, not be pregnant or breastfeeding, and agree to avoid other tobacco/nicotine products and drugs.

Inclusion Criteria

Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen

Expired carbon monoxide (CO): > 6 ppm

Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team

Exclusion Criteria

I am considered a stable candidate without cognitive impairments and do not live in a shelter or treatment facility.

Meet criteria for a current major depressive episode or suicidality according to the PHQ

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Development and Usability Testing

Develop the COSSR app and evaluate its usability with 15 participants over 4 weeks

4 weeks

Remote participation

Treatment

Participants use the COSSR app and nicotine patches to reduce smoking over 3 months

12 weeks

Remote participation with online surveys

Follow-up

Participants are monitored for smoking cessation and app usability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Patches
• Smart Phone App

Trial Overview

The study tests if a smartphone app can help smokers reduce or quit by using the app alongside nicotine patches. Participants will provide feedback on the app's user experience and its effectiveness when combined with the patches.

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 2 Interventions

Participants will also use the app for the duration of the study (about 3 months). Participants will be asked to record your smoking using the app and complete online surveys

Group II: Part 1 Experimental Treatment 2 Interventions

Participants will use the app for 4 weeks, during which participants will follow a smoking schedule on the app to help you reduce your cigarette consumption

Nicotine Patches is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Nicoderm CQ for:

• Smoking cessation

Approved in Canada as Nicoderm for:

• Smoking cessation

Approved in European Union as Nicotine Patches for:

• Smoking cessation

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

A new transdermal nicotine delivery device using switchable carbon nanotube membranes can be programmed to deliver variable doses of nicotine, potentially improving smoking cessation rates beyond the current 25% achieved with traditional methods.

In tests on hairless guinea pigs, this device delivered nicotine at rates 2-2.4 times higher than commercial nicotine patches, suggesting it could provide more effective support for smokers trying to quit when combined with smartphone counseling applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preclinical evaluation of a programmable CNT membrane device for transdermal nicotine delivery in hairless Guinea pigs. Gulati, GK., Berger, LR., Hinds, BJ.[2020]

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2015]

In a study involving 24 male smokers, the Nicoderm nicotine patch delivered significantly higher plasma nicotine concentrations compared to the Habitrol patch, especially in the first 8 hours after application.

Both patches had similar safety profiles, with no significant difference in the incidence of adverse events, but they were not bioequivalent, indicating that Nicoderm may provide a more effective nicotine delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. Gupta, SK., Okerholm, RA., Eller, M., et al.[2019]

In a study involving 802 adults, the transdermal nicotine patch significantly increased smoking cessation rates, achieving a 12% quit rate compared to 5.5% for the placebo group after 6 weeks, demonstrating its efficacy in an over-the-counter setting.

The nicotine patch maintained a 2:1 quit rate advantage over placebo at 24 weeks, with 8.2% of participants in the active group remaining nonsmokers, although 57% of those using the patch reported at least one adverse event.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Davidson, M., Epstein, M., Burt, R., et al.[2019]

In a study of 186 participants, only 1.6% showed delayed contact sensitization to the nicotine transdermal system, indicating a low risk of allergic reactions.

The transdermal nicotine system was well tolerated, with less than 3% of applications causing nonallergic skin irritation, and all reactions resolved without complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the contact sensitization potential of a transdermal nicotine system (Nicoderm) Jordan, WP.[2015]

In a study of 62 heavy smokers, the 30-mg transdermal nicotine patch significantly reduced nicotine dependence and withdrawal symptoms, with 63% of users quitting smoking after 6 weeks compared to 34% in the placebo group.

Although the nicotine patch showed effectiveness in the short term, the long-term abstinence rates after one year were not statistically different between the patch and placebo groups, suggesting that while the patch aids in quitting, maintaining abstinence may still be challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation. Perng, RP., Hsieh, WC., Chen, YM., et al.[2016]

In a study involving 935 healthy volunteers, a new transdermal nicotine system significantly improved smoking cessation rates, with 61% of participants using the 21 mg dose remaining abstinent during the last 4 weeks of treatment compared to only 27% in the placebo group.

The transdermal nicotine system not only increased cessation rates but also effectively reduced withdrawal symptoms and cigarette use among those who did not quit, with no serious adverse effects reported, indicating a safe and effective option for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. [2016]

In a study of 158 smokers, transdermal nicotine patches significantly improved smoking cessation rates, with 39% of participants using 24-hour patches and 35% using patches during wakeful hours achieving abstinence, compared to only 13.5% in the placebo group.

The nicotine patches also effectively reduced tobacco withdrawal symptoms during the initial weeks of quitting, demonstrating their safety and efficacy as an adjunct to low-intervention therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transdermal nicotine delivery as an adjunct to low-intervention smoking cessation therapy. A randomized, placebo-controlled, double-blind study. Daughton, DM., Heatley, SA., Prendergast, JJ., et al.[2017]

In a study of 56 outpatient smokers using a 21 mg/day transdermal nicotine patch, the average cotinine replacement level was 107%, indicating that the patch effectively delivers nicotine, but replacement levels varied widely from 35% to 232%.

Factors such as baseline cotinine levels, prior quit attempts, gender, and nicotine dependence (measured by the Fagerström Tolerance Questionnaire) significantly influenced cotinine replacement, suggesting that individual characteristics should be considered when prescribing nicotine patches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cotinine replacement levels for a 21 mg/day transdermal nicotine patch in an outpatient treatment setting. Gariti, P., Alterman, AI., Barber, W., et al.[2019]

A study of 252 smoking cessation apps for iPhone and 148 for Android revealed that popular apps generally have low adherence to U.S. Public Health Service guidelines, scoring an average of only 12.9 out of 42 on the Adherence Index.

None of the apps recommended calling a quitline, and only 4.1% suggested using approved medications, indicating a significant gap in evidence-based support for users trying to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. Abroms, LC., Lee Westmaas, J., Bontemps-Jones, J., et al.[2022]

The Stop-Tabac app, designed for smoking cessation, is being tested in a large randomized trial with 5200 participants to assess its effectiveness over 6 months, providing personalized support and feedback to users.

This study aims to address the lack of evidence on the impact of health apps for smoking cessation, potentially improving access to support and compliance with nicotine therapy for smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population. Etter, JF., Khazaal, Y.[2021]

The transdermal nicotine system (TNS) effectively doubles smoking cessation rates compared to placebo, with abstinence rates of 36% and 39% in TNS groups versus 23% and 20% in placebo groups over 3 months and 9 weeks, respectively.

The TNS maintains plasma nicotine levels similar to those in smokers, suggesting it can be a practical option for smoking cessation even with minimal support, making it accessible for general medical advice settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of transdermal nicotine in smoking cessation. Müller, P., Abelin, T., Ehrsam, R., et al.[2019]

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