Mobile App + NRT for Quitting Smoking

Recruiting at 2 trial locations

Overseen By Michael Zvolensky, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must be taking: Nicotine replacement

Must not be taking: Smoking cessation drugs

Disqualifiers: Substance abuse, Psychotherapy, Hypertension, others

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

Compensation: Varies

Number of Visits: 3

245 Participants Needed

Trial Summary

What is the purpose of this trial?

We seek to refine and evaluate the novel mobile intervention, Mobile Anxiety Sensitivity Program for Smoking (MASP) which was initially developed and previously tested by our team, targeting sensitivity to interoceptive stress, and to apply it among African American smokers. Our culturally adapted intervention is framed within a sociocultural context of interoceptive stress, which is supported by theory, empirical evidence, and characteristics of African American smokers. The MASP app contains educational content on the history of tobacco and the African American community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any other smoking cessation treatments not provided by the researchers.

What data supports the effectiveness of the treatment MASP app + NRT for quitting smoking?

Research shows that mobile apps can help people quit smoking by providing behavior change techniques and support, as seen in the Smoke Free app study, which found higher quit rates with the full app version. Additionally, a study on HIV-positive smokers using nicotine patches and counseling showed significant quit rates, suggesting that combining mobile app support with nicotine replacement therapy (NRT) could be effective. ^{1 2 3 4 5}

Is the Mobile App + NRT for Quitting Smoking safe for humans?

The research articles reviewed do not provide specific safety data for the Mobile App + NRT for Quitting Smoking. However, they highlight the need for apps to adhere to evidence-based practices, suggesting that safety and effectiveness should be considered in their development. ^{1 3 6 7 8}

What makes the Mobile App + NRT treatment for quitting smoking unique?

The Mobile App + NRT treatment combines a mobile app designed to address anxiety sensitivity with nicotine replacement therapy (NRT), offering a novel approach by targeting both the psychological and physical aspects of smoking addiction. This dual approach is particularly beneficial for individuals with anxiety, as it helps manage anxiety while supporting smoking cessation. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for African American adults who smoke at least 5 cigarettes daily for over 2 years, have high anxiety sensitivity, and are motivated to quit. They must be fluent in English, willing to use nicotine replacement therapy (NRT), and able to complete surveys. Excluded are those under ongoing psychotherapy for anxiety or depression, using other smoking cessation aids, with recent heart attacks or uncontrolled high blood pressure.

Inclusion Criteria

Provide their social security number, residency status, and date of birth

I am willing to keep the study app on my phone for a year.

I am 18 years old or older.

Exclusion Criteria

Non-African American

I am currently using medication or therapy to quit smoking not given by this study's team.

I am currently receiving therapy for anxiety or depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants complete a baseline assessment and receive necessary equipment and instructions for the study

1 week

1 visit (virtual)

Phase II Treatment

Participants use the MASP app and receive NRT for smoking cessation, with app-based check-ins and tailored messages

6 weeks

App-based interactions

Phase III Treatment

Participants receive either MASP 3.0 or QuitGuide app for smoking cessation, with app-based follow-up assessments

30-36 months

App-based interactions

Follow-up

Participants are monitored for smoking cessation outcomes and other measures at various intervals

54 weeks

App-based follow-up assessments at 1, 2, 3, 4, 5, 6, 28, and 54 weeks

Treatment Details

Interventions

• MASP app
• MASP app + NRT
• QuitGuide app
• QuitGuide app + NRT

Trial Overview The study tests a mobile app called MASP designed to help African American smokers manage stress related to quitting by providing educational content on tobacco history within their community. It's compared with the QuitGuide app; both groups receive NRT. Participants will be randomly assigned to one of these interventions.

Participant Groups

Group I: QuitGuide app + NRT Experimental Treatment 1 Intervention

The QuitGuide app is a standard of care app that allows users to track their nicotine cravings, and provides users with motivational messages.

Group II: MASP app + NRT Experimental Treatment 1 Intervention

MASP is an intervention designed to assist African American smokers with anxiety sensitivity quit smoking through the use of educational videos, tailored messages, and interoceptive exercises designed to help the user overcome negative feelings of stress and nicotine withdrawal.

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

University of Oklahoma

Collaborator

Trials

484

Recruited

95,900+

Findings from Research

A study of 955 Dutch smokers and ex-smokers found that the intention to use a smoking cessation app is strongly influenced by the number of previous quit attempts and the level of nicotine dependence, rather than demographic factors like age or education.

Personal innovativeness also plays a significant role in users' attitudes toward cessation apps, indicating that app design should focus on addressing the specific needs and experiences of potential users to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study. Chevalking, SKL., Ben Allouch, S., Brusse-Keizer, M., et al.[2019]

In a study involving 28,112 smokers, the full version of the Smoke Free app significantly increased self-reported smoking abstinence rates at 3 months compared to the reduced version, with odds ratios indicating a nearly doubled likelihood of quitting.

The follow-up rates were low (8.5% for the full version and 6.5% for the reduced version), but the results consistently showed that the full version, which included additional features like daily missions and progress updates, was more effective in helping users quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative effectiveness of a full versus reduced version of the 'Smoke Free' mobile application for smoking cessation: a randomised controlled trial. Crane, D., Ubhi, HK., Brown, J., et al.[2019]

Out of 651 smartphone apps analyzed for smoking cessation, only 15 were focused specifically on this goal, with a majority categorized as calendars or information tools.

The evaluated apps showed a low adherence to established smoking cessation guidelines, with a mean score of only 12.8, indicating a need for improvement and the development of future apps based on evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. Formagini, TD., Ervilha, RR., Machado, NM., et al.[2018]

In an 8-week pilot study involving 8 HIV-positive male smokers, a nurse-managed, peer-led smoking cessation intervention resulted in a 62.5% abstinence rate at the end of treatment, significantly higher than the 0% in the control group.

At the 8-month follow-up, 50% of participants in the intervention group remained abstinent, demonstrating the long-term effectiveness of the intervention compared to the control group, which had no abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of a nurse-managed, peer-led tobacco cessation intervention among HIV-positive smokers. Wewers, ME., Neidig, JL., Kihm, KE.[2017]

The CureApp Smoking Cessation (CASC) app demonstrated a high continuous abstinence rate (CAR) of 64% from weeks 9 to 24 among 55 participants, indicating its effectiveness in supporting long-term smoking cessation.

Participants using the CASC app also showed significant improvements in withdrawal and craving symptoms, suggesting that the app enhances the overall smoking cessation experience when combined with standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Novel Smartphone App (CureApp Smoking Cessation) on Nicotine Dependence: Prospective Single-Arm Interventional Pilot Study. Masaki, K., Tateno, H., Kameyama, N., et al.[2023]

The app-based mindfulness intervention, Unwinding Anxiety, was found to be highly feasible and acceptable among 16 participants with HIV who smoke, with 93% completing the study over eight weeks.

Participants experienced a significant reduction in anxiety levels after four weeks, which correlated with an increase in their readiness to quit smoking, suggesting that addressing anxiety may be crucial for successful smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Delivered Mindfulness Training to Reduce Anxiety in People with HIV Who Smoke: A One-Armed Feasibility Trial. Cioe, PA., Sokolovsky, AW., Brewer, JA., et al.[2023]

The Sense2Quit app was developed specifically for people living with HIV to aid in smoking cessation, utilizing rigorous human-centered design methods and feedback from 20 users and 5 experts during 5 rounds of usability testing.

A total of 66 changes were made to the app based on user feedback, including enhancements to visualizations of smoking behaviors and the addition of features like daily tips and games, indicating a strong focus on improving user experience and engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of visualizations of smoking data for integration into the Sense2Quit app for tobacco cessation. Brin, M., Trujillo, P., Huang, MC., et al.[2023]

A study analyzing the first fifty free smoking cessation apps on Android and iOS found that only 15% involved Nicotine Dependence Treatment Providers (NDTP), indicating a lack of evidence-based support in app development.

Despite over half of the apps being downloaded more than 500,000 times and receiving average ratings around 3.8 out of 5, most apps only provided basic tracking features and limited motivational tips, suggesting a need for more innovative and effective tools for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

QUALITY AND USE OF FREE SMOKING CESSATION APPS FOR SMARTPHONES. Regmi, D., Tobutt, C., Shaban, S.[2019]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Identification of Users for a Smoking Cessation Mobile App: Quantitative Study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Relative effectiveness of a full versus reduced version of the 'Smoke Free' mobile application for smoking cessation: a randomised controlled trial. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. [2018]

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

The feasibility of a nurse-managed, peer-led tobacco cessation intervention among HIV-positive smokers. [2017]

5. Canada pubmed.ncbi.nlm.nih.gov

Impact of a Novel Smartphone App (CureApp Smoking Cessation) on Nicotine Dependence: Prospective Single-Arm Interventional Pilot Study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

App-Delivered Mindfulness Training to Reduce Anxiety in People with HIV Who Smoke: A One-Armed Feasibility Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of visualizations of smoking data for integration into the Sense2Quit app for tobacco cessation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

QUALITY AND USE OF FREE SMOKING CESSATION APPS FOR SMARTPHONES. [2019]

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

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