Smartphone App for Smoking Cessation

(OKquit Trial)

Overseen By Krista Kezbers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

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

Compensation: Varies

Number of Visits: Unknown

Duration: 27 weeks

500 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new smartphone app called OKquit to help smokers quit. It targets smokers who use the Oklahoma Tobacco Helpline and have smartphones. The app provides regular check-ins and personalized messages to support quitting efforts.

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 data supports the effectiveness of the OKquit smoking cessation app treatment?

Research shows that smartphone apps like iCanQuit and CureApp Smoking Cessation have been effective in helping people quit smoking. These apps often include features like craving management tools and can be more effective when combined with other support, such as medications or tailored messages. ^{1 2 3 4 5}

Is the Smartphone App for Smoking Cessation safe for humans?

The available research does not provide specific safety data for the Smartphone App for Smoking Cessation, but similar mobile health programs have been used widely without reported safety concerns. These programs often include features like text message support and crisis line referrals, suggesting a focus on user well-being. ^{1 6 7 8 9}

How is the OKquit smoking cessation app treatment different from other smoking cessation treatments?

The OKquit smoking cessation app is unique because it leverages smartphone technology to provide personalized and interactive support for quitting smoking, which is different from traditional methods like in-person counseling or medication. This app-based approach allows for tailored advice and reminders, making it more accessible and potentially more engaging for users. ^{8 10 11 12 13}

Research Team

Michael S Businelle, PhD

Principal Investigator

University of Oklahoma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Do medications increase the efficacy of digital interventions for smoking cessation? Secondary results from the iCanQuit randomized trial. [2023]

2. Canada 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Web-based smoking cessation intervention that transitions from inpatient to outpatient: study protocol for a randomized controlled trial. [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

The development of the tobacco tactics website. [2021]

5. United States 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. [2022]

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

Spatiotemporal Analysis of Oklahoma Tobacco Helpline Registrations Using Geoimputation and Joinpoint Analysis. [2020]

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

Suicide Prevention Referrals in a Mobile Health Smoking Cessation Intervention. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized trial of Text2Quit: a text messaging program for smoking cessation. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Smoking Cessation: Services and Applications for Mobile Devices. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. England pubmed.ncbi.nlm.nih.gov

How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. [2022]

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

Free smoking cessation mobile apps available in Australia: a quality review and content analysis. [2022]

13. Greece pubmed.ncbi.nlm.nih.gov

Assessment of content, quality and compliance of the STaR mobile application for smoking cessation. [2020]