Mobile Health Smoking Cessation for Quitting Smoking

(PROMOTE-UP Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ramzi Salloum, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Florida

Disqualifiers: Unstable medical, psychiatric illness

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Mobile Health Smoking Cessation for Quitting Smoking?

The iCanQuit smartphone app, which is part of the treatment, has been shown to be more effective than the QuitGuide app for helping people quit smoking, with 24% of users reporting they quit smoking after 12 months compared to 17% using QuitGuide. Additionally, mobile phone text messaging support, like that used in the txt2stop trial, has been shown to double the chances of quitting smoking. ^{1 2 3 4 5}

Is the Mobile Health Smoking Cessation treatment safe for humans?

The Mobile Health Smoking Cessation treatments, including iCanQuit and Motiv8, have been used in various studies and are generally considered safe for humans. These programs are designed to help people quit smoking through mobile apps and text messaging, and they include features like financial incentives and support for mental health, such as suicide prevention referrals. ^{1 4 6 7 8}

How is the Mobile Health Smoking Cessation treatment different from other smoking cessation treatments?

This treatment is unique because it uses mobile health (mHealth) technology, like smartphone apps and text messaging, to help people quit smoking, making it accessible and affordable even for those who can't attend in-person sessions. It also includes a feature for suicide prevention referrals, which is not commonly found in other smoking cessation programs. ^{1 8 9 10 11}

Research Team

Jesse Dallery, PhD

Principal Investigator

University of Florida

Ramzi Salloum, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Florida quit line (Behavioral Intervention)
• iCanQuit (Behavioral Intervention)
• iCanQuit + Motiv8 (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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

Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. [2023]

3. England 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. [2023]

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

Use and effectiveness of quitlines versus Web-based tobacco cessation interventions among 4 state tobacco control programs. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of smoking cessation support delivered by mobile phone text messaging: Txt2stop. [2022]

6. United States 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. [2023]

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

Engaging Smokeless Tobacco Users in Population-Based Cessation Services: Findings From an Observational Study. [2023]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Mobile phone-based interventions for smoking cessation. [2022]

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

Mobile phone text messaging and app-based interventions for smoking cessation. [2022]

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

Mobile phone-based interventions for smoking cessation. [2022]