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

Trial Summary

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.

What data supports the effectiveness of the treatment Smartphone App for Smoking Cessation?

Research shows that tobacco quitlines, like 1-800-QUIT-NOW, are effective in helping people quit smoking by providing accessible, evidence-based support. Additionally, text messaging programs on mobile phones have shown promise in aiding smoking cessation, suggesting that smartphone apps could also be effective by offering similar support and reminders. ^{1 2 3 4 5}

Is the Smartphone App for Smoking Cessation safe for humans?

The research articles do not provide specific safety data for the Smartphone App for Smoking Cessation, but they do discuss the effectiveness of quitlines and apps in helping people quit smoking. ^{1 4 6 7 8}

How does the smartphone app for smoking cessation differ from other treatments?

The smartphone app for smoking cessation is unique because it leverages mobile technology to provide personalized, interactive support and reminders, which can be more accessible and engaging compared to traditional methods like telephone quitlines or text messaging programs. ^{1 2 4 5 9}

What is the purpose of this trial?

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Research Team

Christine Vinci, PhD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

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]

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]

References

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

Perceptions of the US National Tobacco Quitline Among Adolescents and Adults: A Qualitative Study, 2012-2013. [2022]

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

Tobacco quitlines in the United States. [2018]

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

A randomized trial of a pay-for-performance program targeting clinician referral to a state tobacco quitline. [2022]

4. England 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. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

7. England 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. [2022]

8. 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]

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

Cell Phone Ownership and Service Plans Among Low-Income Smokers: The Hidden Cost of Quitlines. [2018]