Smartphone App for Smoking Cessation

(OKquit Trial)

Overseen By Krista Kezbers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must be taking: Nicotine replacement

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

Compensation: Varies

Number of Visits: Unknown

Duration: 27 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartphone app, OKquit, designed to help people quit smoking. OKquit offers personalized messages and on-demand content to support users, potentially making it easier than traditional methods like phone counseling. Participants will receive either standard helpline care or the same care plus access to the new app. This study suits smokers in Oklahoma who currently smoke at least five cigarettes a day, are willing to quit within three weeks, and have a smartphone.

As an unphased trial, this study explores innovative, personalized support for quitting smoking.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on smoking cessation and using a smartphone app, so it's likely you can continue your medications, but you should confirm with the study team.

What prior data suggests that this smartphone app is safe for smoking cessation?

Research has shown that smartphone apps for quitting smoking, like OKquit, are generally safe to use. Many similar apps, such as QuitSure and quitSTART, have gained popularity among those trying to quit smoking. Users often report that these apps help them manage withdrawal symptoms and provide support without causing side effects.

OKquit is part of a larger treatment plan, which includes standard helpline support and nicotine replacement therapy. These methods are well-known for helping people quit smoking and are considered safe. The OKquit app adds personalized messages and support, which is expected to ease the quitting process without adding any risks.

In summary, evidence on similar apps and treatments suggests that OKquit should be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OKquit app for smoking cessation because it offers personalized support through tailored messages and on-demand content directly on your smartphone. Unlike the standard helpline care that primarily relies on phone-based support, OKquit integrates technology to provide continuous, interactive engagement. This innovative approach could make quitting smoking more accessible and appealing, especially for those who prefer digital solutions over traditional methods.

What evidence suggests that the OKquit app is effective for smoking cessation?

Research has shown that smartphone apps for quitting smoking, such as OKquit, are promising tools to help smokers quit. In this trial, participants in the OKquit group will receive tailored smoking cessation messages through the app, along with standard helpline care. Specifically, one study found that the iCanQuit app helped 34% of users quit smoking, compared to 20% with the QuitGuide app. This finding suggests that personalized content and messages can significantly impact success rates. These apps provide flexible and easy support, which is particularly beneficial for those who may not find traditional methods helpful. Overall, evidence indicates that smartphone-based tools can effectively support individuals in their journey to stop smoking. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael S Businelle, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for adults in Oklahoma who smoke at least 5 cigarettes a day, are willing to quit within 21 days after starting the study, and can use a smartphone compatible with the Insight mHealth Platform. They must be able to complete daily and weekly surveys for 27 weeks. People with low health literacy (as measured by REALM-SF) or without an Oklahoma address are excluded.

Inclusion Criteria

Possession of an active smartphone that is compatible with the Insight mHealth Platform

Provide evidence that they are a current smoker (e.g., text a picture of their pack of cigarettes when requested during the screening call)

Valid Oklahoma residential address to mail study materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Remote screening via phone, email, or text

Baseline and Randomization

Participants complete a baseline survey and are randomized into intervention groups

1 week

Remote baseline survey and randomization call

Treatment

Participants receive daily check-ins and weekly surveys via the smartphone app, with tailored messages for the OKquit group

27 weeks

Daily and weekly remote app-based interactions

Follow-up

Participants are monitored for smoking abstinence and engagement with the app

4 weeks

Remote follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• OKquit
• Standard Helpline Care

Trial Overview

The study tests a new smoking cessation app called OKquit against Standard Helpline Care provided by the Oklahoma Tobacco Helpline. Participants will either get standard care plus daily check-ins and weekly surveys through an app or this standard care along with additional features from the OKquit app.

How Is the Trial Designed?

Group I: The Standard Helpline Care (SC) group Active Control 1 Intervention

The SC group will receive standard Oklahoma Smoking Cessation Helpline care AND complete daily check-ins and weekly surveys for 27 weeks.

Group II: OKquit group Active Control 1 Intervention

The OKquit group will receive SC plus daily check-ins and weekly surveys for 27 weeks. In addition, the OKquit group will receive tailored smoking cessation messages in the smartphone application following completion of each survey. Further, the OKquit group will have access to on-demand smoking cessation content through the app.

OKquit is already approved in United States for the following indications:

Approved in United States as OKquit for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

The study analyzed registrations to the Oklahoma Tobacco Helpline from January 2006 to June 2017, revealing that American Indian participants were more concentrated in rural areas with a larger tribal presence, compared to other racial groups.

There were significant trends in Helpline registrations, with a notable increase in American Indian registrations from July 2008 to March 2009, suggesting a need for targeted public health efforts to sustain and enhance tobacco cessation support in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatiotemporal Analysis of Oklahoma Tobacco Helpline Registrations Using Geoimputation and Joinpoint Analysis. Dilekli, N., Janitz, A., Martinez, S., et al.[2020]

The iCanQuit smartphone app significantly outperformed the QuitGuide app in helping participants quit smoking, achieving a 34% quit rate compared to 20% for QuitGuide among those using FDA-approved cessation medications.

Using nicotine replacement therapy (NRT) alongside the iCanQuit app led to even higher quit rates of 40%, suggesting that combining the app with cessation medications can enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial. Bricker, JB., Santiago-Torres, M., Mull, KE., et al.[2023]

In a study involving 425 adult smokers, the addition of craving management tools in the BupaQuit app did not significantly improve smoking cessation rates compared to a control app without these tools, with only 13.5% of the intervention group achieving 14-day continuous abstinence versus 15.7% in the control group.

Overall app usage was similar between both groups, suggesting that limited engagement with the app may have contributed to the lack of effectiveness in enhancing cessation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial. Herbec, A., Shahab, L., Brown, J., et al.[2022]

A study of 225 Android smoking cessation apps revealed that most apps provide basic tools and only address an average of 2.1 out of 5 recommended support strategies (the 5As), with minimal tailoring features present.

Apps that included more tailored features, such as two-way interactions and proactive alerts, were significantly more popular and received higher user ratings, indicating that users prefer and value tailored support in smoking cessation apps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. Hoeppner, BB., Hoeppner, SS., Seaboyer, L., et al.[2022]

Out of 112 smoking cessation apps reviewed, only six were identified as high-quality and partially adhered to Australian smoking cessation treatment guidelines, indicating a lack of robust options for users.

Only two of the high-quality apps had their efficacy evaluated, highlighting the need for more research to assess the effectiveness of smoking cessation apps and ensure they provide reliable support for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free smoking cessation mobile apps available in Australia: a quality review and content analysis. Thornton, L., Quinn, C., Birrell, L., et al.[2022]

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]

Automated mobile health programs like SmokefreeVET effectively support smoking cessation through text messaging, with nearly 7% of enrollees accessing suicide prevention resources.

Incorporating suicide prevention hotline referrals into smoking cessation mHealth interventions is recommended due to the significant overlap between smoking and suicide risk, enhancing the support provided to users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide Prevention Referrals in a Mobile Health Smoking Cessation Intervention. Christofferson, DE., Hamlett-Berry, K., Augustson, E.[2022]

Mobile health applications are effective tools for helping individuals change their smoking habits, as they provide counseling and motivation for smoking cessation.

The review analyzed 12 studies that highlighted four different technological approaches, demonstrating the versatility and potential of mobile devices in supporting smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. Kefaliakos, A., Pliakos, I., Chardalias, K., et al.[2018]

The study aims to evaluate the effectiveness of the 'CureApp Smoking Cessation' (CASC) app in improving smoking cessation rates among individuals with nicotine dependence, alongside a standard 12-week treatment program, with a total of 580 participants expected to be recruited.

CASC is designed to enhance treatment outcomes by providing personalized support through video tutorials, AI advice, and CO monitoring, and the primary outcome will be the continuous abstinence rate from weeks 9-24, which is anticipated to be significantly higher than that of a control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. Nomura, A., Tateno, H., Masaki, K., et al.[2020]

The Decide2Quit program, a tailored web-based and e-message smoking cessation intervention, is being tested on 1,488 hospitalized smokers to evaluate its effectiveness in promoting tobacco cessation after discharge.

The primary outcome of the study is self-reported 30-day tobacco abstinence at 6 months, with secondary outcomes including various quit rates and cost-effectiveness assessments, highlighting the program's potential for broad implementation with minimal burden on hospital staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. Harrington, KF., McDougal, JA., Pisu, M., et al.[2021]

The Tobacco Tactics website, designed for veterans, underwent usability testing and received positive feedback, leading to over 27 modifications to enhance user experience, with 83% of participants finding it enjoyable and easy to navigate.

In a pilot study, veterans using the Tobacco Tactics website along with nicotine replacement therapy achieved a 40% abstinence rate at 30 days, compared to only 13% in the control group, indicating its potential effectiveness in helping veterans quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. Duffy, SA., Fowler, KE., Flanagan, PS., et al.[2021]

The STaR smartphone application for smoking cessation received an average quality score of 3.31 and a compliance score of 2.50 on a 5-point scale, indicating it meets some but not all quality standards for smoking cessation support.

The app effectively incorporates key components of smoking cessation guidelines, including the 5A and 5R approaches, suggesting that enhancing its content could further improve its effectiveness in helping users quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of content, quality and compliance of the STaR mobile application for smoking cessation. Regmi, K., Kassim, N., Ahmad, NH., et al.[2020]

The Text2Quit program significantly increased biochemically confirmed smoking abstinence rates, with 11.1% of participants in the intervention group remaining smoke-free compared to only 5.0% in the control group, indicating a relative risk of 2.22.

Self-reported smoking abstinence was also higher in the Text2Quit group (19.9%) compared to the control group (10.0%), suggesting that the program is effective across various demographic groups, particularly among non-white participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of Text2Quit: a text messaging program for smoking cessation. Abroms, LC., Boal, AL., Simmens, SJ., et al.[2022]

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quitSTART App · They make quitting less painful · Quit smoking medicines are much safer than smoking · They help you get through the toughest times.