Smartphone App for Smoking Cessation

Overseen By Marilyn Horta, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Household member enrolled

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

3600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a smartphone app in helping people quit smoking when used alongside regular quitline services. Participants will use either the quitline alone, the quitline with a smartphone app, or an updated version of the app designed to be more engaging. The study seeks individuals who smoke daily and have either recently quit or currently smoke at least three cigarettes a day. Smartphone owners interested in quitting smoking may find this trial suitable. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important research on smoking cessation.

Do I need to stop my current medications to join the trial?

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 has shown that smartphone apps designed to help people quit smoking are generally safe. These apps can manage cravings and offer personalized quitting plans without causing significant side effects. For example, a study on an app called OKquit found that users found it easy to use and did not report any serious problems. The app sends personalized messages to help people quit smoking, which users found helpful and not bothersome.

Various studies have tested these types of apps, and participants usually receive them well. The aim is to provide tools to help users resist smoking, and so far, they seem to do this safely. While studies have not found any major safety issues, participants should always share their experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help people quit smoking using smartphone technology. Unlike traditional methods like nicotine replacement or counseling, this trial combines quitline services with a smartphone app that tracks smoking urges and abstinence. One arm even includes an updated app designed to be more engaging and user-friendly, enhancing user satisfaction. Another arm takes it further by introducing smoking extinction trials after 48 hours of abstinence, potentially making the quitting process more effective. This blend of technology and traditional support could offer a more interactive and personalized quitting experience.

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

Research has shown that smartphone apps can help people quit smoking. One study found that users of the iCanQuit app were more likely to stop smoking, particularly after 26 weeks. Another study revealed that the SmartQuit 2.0 app helped 21% of users quit smoking and 75% reduce their smoking. In this trial, participants will be assigned to different treatment arms: one will update an existing smartphone app to enhance user engagement and satisfaction, another will use quitline services only, and a third will combine quitline services with a smartphone app. Using these apps alongside quitline services may make quitting easier and more appealing. These apps offer support and help track smoking urges, assisting users in staying smoke-free. ^{1 5 6 7 8}

Who Is on the Research Team?

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who smoke daily and either quit within the last 3 months or currently smoke at least 3 cigarettes a day. Participants must have a smartphone that supports AR, be willing to download an app, and speak English. People with another household member in the study can't join.

Inclusion Criteria

I quit smoking recently or smoke at least 3 cigarettes daily for the past year.

I have a working phone.

I own a smartphone that supports AR and am willing to download an app.

Exclusion Criteria

Has another household member already enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

App Update and User Satisfaction

Update the existing smartphone app to be engaging and user-friendly, and verify user satisfaction

1 week

1 visit (virtual)

Treatment

Participants receive usual care for smoking cessation via the quitline and use a smartphone app to track smoking urges and abstinence

6 months

Follow-up

Participants are monitored for smoking abstinence and app usability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Quitline Services
• Quitline Services and Smartphone App
• Updating Existing Smartphone App

Trial Overview The study tests if using a smartphone app that exposes users to smoking cues can help people stop smoking when combined with Quitline services. Some will use just Quitline services, others will get additional support from updating an existing app.

How Is the Trial Designed?

Group I: Aim 2:Quitline plus smartphone App Experimental Treatment 3 Interventions

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.

Group II: Aim 2: Quit Line Only Experimental Treatment 1 Intervention

Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence.

Group III: Aim 1: Update an existing smartphone App Experimental Treatment 1 Intervention

An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

A pay-for-performance program significantly increased the rate of referrals to tobacco quitline services, with intervention clinics referring 11.4% of smokers compared to only 4.2% in usual care clinics, based on a study involving 49 clinics.

The program was particularly effective in clinics that had previously been less engaged in quality improvement, demonstrating that financial incentives can enhance clinician referral rates to evidence-based smoking cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a pay-for-performance program targeting clinician referral to a state tobacco quitline. An, LC., Bluhm, JH., Foldes, SS., et al.[2022]

A survey of 773 smokers revealed that 63.2% of low-income smokers rely solely on cell phones, which can limit their access to quitline (QL) services due to potential costs associated with cell minutes.

Robust use of QL services could consume 11%-29% of a low-income smoker's typical 250 monthly cell minutes, suggesting that exempting QL calls from counting against calling plans could enhance access to this effective treatment for tobacco dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Phone Ownership and Service Plans Among Low-Income Smokers: The Hidden Cost of Quitlines. Bernstein, SL., Rosner, JM., Toll, B.[2018]

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]

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]

Tobacco use is the leading preventable cause of death and disability in the U.S., highlighting the urgent need for effective cessation resources.

Establishing a national tobacco quitline network, as recommended in 2003, can significantly reduce tobacco use by providing accessible, evidence-based support through health professionals, emphasizing the importance of collaboration between nurses and quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco quitlines in the United States. Fildes, EE., Wilson, MA., Crawford, BJ., et al.[2018]

A study involving 159 participants revealed that while many smokers, including adolescents, are aware of quitline services, there is a lack of interest in using them, with some only considering it if they struggle to quit on their own.

To enhance the effectiveness of quitlines in promoting smoking cessation, future marketing should focus on educating smokers about the free and confidential nature of these services and their benefits, potentially increasing call volume and improving public health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of the US National Tobacco Quitline Among Adolescents and Adults: A Qualitative Study, 2012-2013. Waters, EA., McQueen, A., Caburnay, CA., et al.[2022]

The study found that the placement of antismoking advertisements and higher television target audience rating points (TARPS) significantly increased calls to Quitline Victoria, indicating that effective advertising can enhance public engagement with smoking cessation resources.

Calls to Quitline were highest from Monday to Wednesday, suggesting that timing and frequency of advertisements may play a crucial role in maximizing the effectiveness of tobacco control interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the relation between placement of Quit antismoking advertisements and number of telephone calls to Quitline: a semiparametric modelling approach. Erbas, B., Bui, Q., Huggins, R., et al.[2022]

The national Tips campaign effectively increased calls to the 1-800-QUIT-NOW quitline in both states with and without alternate quitline numbers, indicating its broad impact on tobacco cessation efforts.

However, states with alternate quitline numbers experienced fewer absolute calls to 1-800-QUIT-NOW, suggesting that having a state-specific number may divert some calls away from the national quitline, with an average decrease of 98 calls per week in those areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of State-Specific Quitline Numbers on Call Volume During a National Tobacco Education Campaign Promoting 1-800-QUIT-NOW. Zhang, L., Malarcher, A., Mann, N., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5183543/

Single-Arm Trial of the Second Version of an Acceptance & ... Participants were receptive (73%-84%) to the SmartQuit 2.0 smoking cessation app. The app's quit rate was 21% (7D PP) and smoking reduction rate was high (75%).

2. researchprotocols.org researchprotocols.org/2024/1/e56827

Smartphone-Based Smoking Cessation Intervention ... Adjunctive smartphone-based cessation apps such as OKquit could increase convenience, appeal, reach, and effectiveness of quitline services.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39088254

Smartphone-Based Smoking Cessation Intervention (OKquit ... This study will examine the efficacy of OKquit, a low-burden smartphone-based app for smoking cessation.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871616309802

Single-arm trial of the second version of an acceptance & ... Participants were receptive (73%–84%) to the SmartQuit 2.0 smoking cessation app. •. The app's quit rate was 21% (7D PP) and smoking reduction ...

5. pulmonologyadvisor.com pulmonologyadvisor.com/news/smoking-cessation-apps-smart-t-vs-nci-quitguide/

Quit Rate Higher With Smart-T vs NCI QuitGuide The Smart-T app may more effectively support smoking cessation in adults with lower socioeconomic status than the NCI QuitGuide app.

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2770816

Efficacy of Smartphone Applications for Smoking Cessation This randomized clinical trial examines the efficacy of a smartphone application for smoking cessation based on acceptance and commitment ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03740490

Smartphone Based Smoking Cessation Intervention The Smart-T app uses a lapse risk estimator to identify moments of heightened risk for lapse, and the algorithm tailors treatment messages in real-time based ...

8. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.