Mobile Health Smoking Cessation for Quitting Smoking

(PROMOTE-UP Trial)

Overseen By Ramzi Salloum, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Unstable medical, psychiatric illness

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

Compensation: Varies

Number of Visits: 2

Duration: 7 weeks

1332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method best helps people quit smoking: the iCanQuit app, the iCanQuit app plus Motiv8, or the Florida quit line. The iCanQuit app assists users in accepting and managing their smoking triggers. The iCanQuit + Motiv8 option includes a device that checks breath for smoking markers, while the Florida quit line provides telephone support for smoking cessation. The study seeks participants who smoke, are over 21, receive care at certain clinics, and have daily access to a smartphone. As an unphased trial, it offers a unique opportunity to explore innovative methods 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments under study for smoking cessation are generally safe. The iCanQuit app has proven effective and user-friendly. In past studies, it helped more people quit smoking compared to other apps, without major safety concerns. The Motiv8 addition includes a device that checks smoking status and has been used in many studies without major issues.

The Florida quit line is another widely used option, offering phone counseling as part of state-supported programs. This service also provides additional resources like medications, which are safe when used as directed.

Overall, these options have been used in various settings without reports of serious side effects. They aim to help people quit smoking safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for smoking cessation because they leverage modern technology to enhance support and accountability. The iCanQuit app uses cognitive behavioral therapy and acceptance and commitment therapy (ACT) principles to help users accept smoking triggers and stay committed to their values, making it a personalized and flexible option. iCanQuit+Motiv8 goes a step further by incorporating a breath carbon monoxide monitor that connects to a smartphone, providing tangible feedback on smoking status and offering a unique form of contingency management. Unlike traditional methods like telephone counseling from the Florida quit line, these app-based treatments integrate seamlessly into daily life, offering users a more interactive and engaging way to quit smoking.

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

Research has shown that the iCanQuit app, one of the treatments in this trial, helps people quit smoking. After 12 months, those using iCanQuit were 1.46 times more likely to quit than those using another app, QuitGuide, with 27% quitting compared to 20%. In this trial, some participants will use the iCanQuit app combined with the Motiv8 approach, which uses a breath monitor to check smoking status. Early results suggest this combination could improve quitting success by providing real-time feedback.

Another treatment arm in this trial involves the Florida quit line. Past data shows it has helped over 295,000 Floridians quit tobacco, indicating that phone counseling can be a powerful tool for quitting smoking. Together, these treatments offer different ways to quit smoking, each supported by evidence. ^{2 6 7 8 9}

Who Is on the Research Team?

Jesse Dallery, PhD

Principal Investigator

University of Florida

Ramzi Salloum, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for individuals over 21 who smoke and want to quit. They must have daily access to a smartphone, be referred by their primary care provider, and receive care at a participating clinic. People with unstable medical or psychiatric conditions cannot join.

Inclusion Criteria

Receiving care at one of the participating clinics

No household members already enrolled

I am 21 years old or older.

Exclusion Criteria

I do not have any unstable medical or mental health conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants complete the first 4 iCanQuit modules to prepare for their quit day

1-2 weeks

Treatment

Participants receive one of three smoking cessation therapies: iCanQuit, iCanQuit+Motiv8, or Florida quit line

7 weeks

Follow-up

Participants are monitored for smoking cessation and other outcomes

12 months

Visits at months 2, 6, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Florida quit line
• iCanQuit
• iCanQuit + Motiv8

Trial Overview

The study compares three smoking cessation methods: the iCanQuit mobile app, iCanQuit combined with another app called Motiv8, and the Florida quit line service. It aims to find out which is most effective in helping underserved patients stop smoking.

How Is the Trial Designed?

Group I: iCanQuit+Motiv8 Active Control 1 Intervention

Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.

Group II: Florida quit line Active Control 1 Intervention

The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.

Group III: iCanQuit Active Control 1 Intervention

iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.

Florida quit line is already approved in United States for the following indications:

Approved in United States as Florida Quitline for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

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 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]

After implementing changes to the QUITPLAN® Services in Minnesota, there was a significant increase in smokeless tobacco users enrolling in quitline services, unlike in Wisconsin where no change was observed.

Popular features such as a 2-week starter kit of nicotine replacement therapy and online registration contributed to the increased participation of smokeless tobacco users in Minnesota, indicating that tailored quitline services can effectively engage this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Smokeless Tobacco Users in Population-Based Cessation Services: Findings From an Observational Study. Keller, PA., Boyle, RG., Lien, RK., et al.[2023]

Mobile phone-based interventions, particularly text messaging, significantly improve long-term smoking cessation rates, with a risk ratio of 1.71 based on a meta-analysis of five studies involving over 9,000 participants.

While the evidence supports the effectiveness of these interventions, there is substantial variability in results, indicating that further research is needed to explore different types of mobile interventions and their effectiveness in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based interventions for smoking cessation. Whittaker, R., McRobbie, H., Bullen, C., et al.[2022]

This study will compare the effectiveness of three smoking cessation interventions—Florida Quitline, iCanQuit alone, and iCanQuit combined with Motiv8—across 1,332 adult smokers in underserved primary care settings, focusing on 7-day smoking abstinence at 6 months as the primary outcome.

The use of mobile health (mHealth) interventions like iCanQuit and Motiv8 aims to improve access to smoking cessation resources, potentially enhancing community health outcomes and patient satisfaction in diverse healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of mobile health smoking cessation approaches among underserved patients in primary care: Study protocol for the PROMOTE-UP trial. Salloum, RG., Bricker, JB., Lee, JH., et al.[2023]

Mobile phone-based interventions, particularly text message programs, significantly increased short-term quitting rates among smokers, with a risk ratio of 2.18, indicating that participants were more than twice as likely to report quitting in the short term compared to those not using these interventions.

However, the evidence for long-term effectiveness is inconclusive, as significant variability was found in long-term outcomes, and the authors call for more rigorous studies to assess the lasting impact of these mobile interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone-based interventions for smoking cessation. Whittaker, R., Borland, R., Bullen, C., et al.[2022]

The pilot study involving 71 participants showed that the iQuit Mindfully text messaging program, when combined with Mindfulness-Based Addiction Treatment (MBAT), was feasible and well-received, with high engagement rates (88% read most texts) and strong retention (76% completed treatment).

Biochemically confirmed smoking cessation rates were 22% at the end of treatment and 19% at 1-month follow-up, indicating that while the text messaging support did not significantly change cessation rates compared to MBAT alone, it provided valuable support, especially for low-income smokers facing barriers to quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. Spears, CA., Abroms, LC., Glass, CR., et al.[2023]

In a study involving 4086 smokers, quitline users had a higher 30-day point prevalence abstinence (PPA) rate of 32% compared to 27% for Web-based users, indicating that quitlines may be more effective for tobacco cessation.

After adjusting for demographic factors, quitline users had 1.26 times the odds of achieving abstinence compared to Web-based users, suggesting that traditional quitline support may offer additional benefits in helping individuals quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use and effectiveness of quitlines versus Web-based tobacco cessation interventions among 4 state tobacco control programs. Neri, AJ., Momin, BR., Thompson, TD., et al.[2022]

The iCanQuit smartphone application, which uses Acceptance and Commitment Therapy (ACT), was found to be more effective for helping highly nicotine-dependent adults quit tobacco compared to the QuitGuide application, with a 30-day abstinence rate of 24% versus 17% at 12 months.

Participants using iCanQuit not only reported higher rates of quitting but also engaged with the app more frequently and expressed greater satisfaction, indicating that the increase in acceptance of smoking cues played a key role in the success of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy-Based Smartphone Applications for Cessation of Tobacco Use among Adults with High Nicotine Dependence: Results from the iCanQuit Randomized Trial. Santiago-Torres, M., Mull, KE., Sullivan, BM., et al.[2023]

The txt2stop trial demonstrated that mobile-phone-based smoking cessation support significantly increases quitting rates, with an estimated cost of £278 per additional quitter, making it a cost-effective intervention.

Incorporating future healthcare savings from reduced smoking-related diseases, the text-based support not only improves health outcomes, gaining 18 life years and 29 quality-adjusted life years per 1,000 smokers, but is also projected to be cost-saving for the NHS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop. Guerriero, C., Cairns, J., Roberts, I., et al.[2022]

Automated text messaging interventions for smoking cessation significantly increase quit rates compared to minimal support, with a risk ratio of 1.54 based on 13 studies involving over 14,000 participants.

Text messaging added to other smoking cessation methods also shows improved effectiveness, with a risk ratio of 1.59, indicating that it enhances the success of existing interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging and app-based interventions for smoking cessation. Whittaker, R., McRobbie, H., Bullen, C., et al.[2022]

Citations

1.

floridahealth.gov

floridahealth.gov/programs-and-services/prevention/tobacco-free-florida/_documents/2024-tff-annual-report.pdf

2024 Annual Report

Since the TFF program began in 2007, more than 295,000 Floridians have successfully quit tobacco using one of TFF's free tools and services. There are now ...

2.

cdc.gov

cdc.gov/pcd/issues/2020/19_0271.htm

Effect of a Statewide Media Campaign on Smoking ...

The study found that exposure to the Tobacco Free Florida campaign influenced the rate of quit attempts among adult smokers in Florida.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7085912/

Effect of a Statewide Media Campaign on Smoking ...

The study found that exposure to the Tobacco Free Florida campaign influenced the rate of quit attempts among adult smokers in Florida.

4.

pdastats.com

pdastats.com/wp-content/uploads/2022/06/2020-Florida-Priority-Population-Quit-Rates-full-report.pdf

Tobacco Free Florida Cessation Programs:

This report examines the effectiveness of the current BTFF cessation programs for tobacco users within five demographic groups for which sufficient data were.

5.

tobaccofreeflorida.com

tobaccofreeflorida.com/

Tobacco Free Florida | Smoking Cessation Information ...

Whenever you feel ready to quit tobacco, our free tools and resources can help you with the first step. Check out our Quit Your Way program.

6.

floridahealth.gov

floridahealth.gov/programs-and-services/prevention/tobacco-free-florida/index.html

Tobacco Free Florida

To learn more about the effects of tobacco use and the free quit tools and services available, please visit the Tobacco Free Florida website.

7.

cdc.gov

cdc.gov/pcd/issues/2023/23_0033.htm

A Safety Net Tobacco Use Cessation Resource: Quitline ...

Among quitlines that reported medication data (n = 38 of 40), 65.2% of callers overall received cessation medications in addition to counseling ...

8.

flboardofmedicine.gov

flboardofmedicine.gov/forms/team-up-to-quit.pdf

Team Up to Quit

Classes are offered in every county. The toll-free Florida Quitline at 1-877-U-CAN-NOW (1-877-822-6669) allows you to speak with a trained and certified Quit ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11593654/

Participation in Tobacco Cessation Programs Among ...

Partnered with state cessation services through Tobacco Free Florida (TFF) for quitline, online, and group therapy. Participants received ...