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

Trial Summary

What is the purpose of this trial?

To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit 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 data supports the effectiveness of the treatment Smartphone App + Nicotine Patches for Smoking Cessation?

Research shows that nicotine patches can nearly double the chances of quitting smoking compared to not using them, and smartphone apps can provide additional support to help people quit smoking. Combining these two methods may increase the likelihood of successfully quitting smoking. ^{1 2 3 4 5}

Is the combination of smartphone apps and nicotine patches safe for smoking cessation?

The transdermal nicotine patch has been shown to be generally safe for smoking cessation, with minimal side effects reported in studies. While the specific combination with a smartphone app hasn't been detailed, the patch itself is considered safe for use in humans. ^{6 7 8 9 10}

How is the treatment using smartphone app and nicotine patches for smoking cessation different from other treatments?

This treatment is unique because it combines nicotine patches with a smartphone app, allowing for personalized and adjustable nicotine delivery, which can be remotely controlled and tailored to the individual's needs, potentially improving smoking cessation rates compared to standard nicotine patches alone. ^{5 8 10 11 12}

Research Team

Yong Cui, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

Seeking smoking cessation treatment

Fluency in spoken and written English

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

Exclusion Criteria

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

I am currently taking medication for mental health, seizures, or pain.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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 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 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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A content analysis of popular smartphone apps for smoking cessation. [2022]

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

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

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

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

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

The use of transdermal nicotine in smoking cessation. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

[Effects of transdermal nicotine as an adjunct in smoking cessation therapy. A double-blind randomized study controlled with placebo]. [2015]

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

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

7. Ireland pubmed.ncbi.nlm.nih.gov

Cotinine replacement levels for a 21 mg/day transdermal nicotine patch in an outpatient treatment setting. [2019]

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

Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. [2019]

9. Singapore pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled study of transdermal nicotine patch for smoking cessation. [2016]

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

Comparison of the pharmacokinetics of two nicotine transdermal systems: nicoderm and habitrol. [2019]

11. United States 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. [2017]

12. Netherlands pubmed.ncbi.nlm.nih.gov

A preclinical evaluation of a programmable CNT membrane device for transdermal nicotine delivery in hairless Guinea pigs. [2020]