Smartphone Program for Smoking Cessation

Overseen By MacKenzie Utley, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pivot Health Technologies Inc.

Must not be taking: Nicotine replacement therapy

Disqualifiers: Pregnancy, Marijuana use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a smartphone app designed to help people quit smoking by switching to smoke-free nicotine products, such as e-cigarettes or nicotine pouches. It targets smokers who have previously attempted to quit without success and are currently using these alternative nicotine options. Participants should be comfortable using smartphone apps and interested in switching to reduced-risk nicotine products to stop smoking cigarettes. The study is open to U.S. residents who smoke at least five cigarettes on most days and have done so for six months or more. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could lead to new methods for quitting smoking.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, you cannot use nicotine replacement therapy, chewing tobacco, or cigars while participating.

What prior data suggests that the Pivot cigarette smoking cessation program is safe?

Research shows that the Pivot program for quitting smoking is user-friendly. Pivot, an online tool, assists people in stopping smoking. Studies have found that users of Pivot are nearly twice as likely to quit smoking compared to those using other methods. This indicates that users find it easy to follow and adhere to the program.

While specific information on negative effects is not available, the program's wide availability and use suggest it is safe for most people. Pivot helps users develop better habits to quit smoking, providing valuable support for those who want to stop. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional smoking cessation aids like nicotine replacement therapies or prescription medications, the Pivot program is a mobile app that combines technology with behavioral support to help people quit smoking. Researchers are excited about this program because it provides real-time feedback and personalized strategies, making quitting more interactive and engaging. This app-based approach can be more accessible and convenient, allowing users to access support anytime and anywhere, which could potentially increase the success rates for quitting smoking.

What evidence suggests that the Pivot program is effective for smoking cessation?

Research has shown that the Pivot program for quitting smoking, which participants in this trial will use, yields promising results. One study found that 44% of Pivot users quit smoking after one year. This success rate surpasses some other programs and was confirmed with medical tests. The program also helped individuals remain smoke-free for up to 52 weeks. These findings suggest that Pivot can be an effective tool for those wanting to quit smoking. ^{5 6 7 8 9}

Who Is on the Research Team?

Jennifer Marler, MD

Principal Investigator

Pivot Health Technologies Inc.

Are You a Good Fit for This Trial?

This trial is for adult smokers who have tried and failed to quit before, and are currently using other smoke-free nicotine products. They should be interested in quitting cigarettes by switching to these alternative products.

Inclusion Criteria

I plan to switch to a lower-risk nicotine product instead of smoking.

Resident of the United States

Able to read and comprehend English

Exclusion Criteria

Failure to provide contact or collateral information, and/or failure to verify email address

Pregnant or breast-feeding

Smokes marijuana ≥ 4 days per week

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening form and phone call

Treatment

Participants use the Pivot cigarette smoking cessation program, including a mobile breath sensor and smartphone app with coaching

12 weeks

Remote participation with online questionnaires and video call for biovalidation

Follow-up

Participants are monitored for changes in smoking behavior and program engagement

14 weeks

Remote participation with online questionnaires

What Are the Treatments Tested in This Trial?

Interventions

• Pivot cigarette smoking cessation program

Trial Overview

The study is testing the Pivot smoking cessation program, which aims to help participants quit cigarette smoking through a smartphone-based switch program. Up to 120 people will join this open label, single center study.

How Is the Trial Designed?

Group I: Pivot cigarette smoking cessation program Experimental Treatment 1 Intervention

A commercially available mobile phone app and program for smoking cessation

Who Is Running the Clinical Trial?

Pivot Health Technologies Inc.

Lead Sponsor

Trials

4

Recruited

490+

Published Research Related to This Trial

The study aims to evaluate the effectiveness of the 'CureApp Smoking Cessation' (CASC) app in improving smoking cessation rates among individuals with nicotine dependence, alongside a standard 12-week treatment program, with a total of 580 participants expected to be recruited.

CASC is designed to enhance treatment outcomes by providing personalized support through video tutorials, AI advice, and CO monitoring, and the primary outcome will be the continuous abstinence rate from weeks 9-24, which is anticipated to be significantly higher than that of a control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. Nomura, A., Tateno, H., Masaki, K., et al.[2020]

The Pivot smoking cessation program showed significant long-term effectiveness, with 35.4% of participants achieving 7-day point prevalence abstinence and 31.3% achieving 30-day point prevalence abstinence three months after completing the program.

Participants reduced their cigarette consumption by an average of 52.6%, and many who achieved short-term abstinence maintained it, indicating that the program not only helps smokers quit but also supports sustained cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Durability of Abstinence After Completing a Comprehensive Digital Smoking Cessation Program Incorporating a Mobile App, Breath Sensor, and Coaching: Cohort Study. Marler, JD., Fujii, CA., Galanko, JA., et al.[2021]

In a randomized controlled trial with 188 smokers, the Pivot smoking cessation program showed significantly higher engagement (mean app openings) compared to the QuitGuide app, indicating better user interaction with the program.

Pivot also demonstrated superior biovalidated cessation rates at 12 weeks (29% vs. 13%) and 26 weeks (21% vs. 10%) compared to QuitGuide, suggesting it is a more effective mobile solution for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. Marler, JD., Fujii, CA., Utley, MT., et al.[2022]

The Pivot digital smoking cessation program showed promising engagement, with participants actively involved for an average of 12.4 weeks, and significant improvements in attitudes towards quitting, such as increased confidence and decreased expected difficulty in maintaining abstinence.

At the end of the program, 32.4% of participants achieved 30-day point prevalence abstinence, demonstrating that Pivot can effectively support both smokers ready to quit and those who are not, potentially expanding access to smoking cessation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Assessment of a Comprehensive Digital Smoking Cessation Program That Incorporates a Mobile App, Breath Sensor, and Coaching: Cohort Study. Marler, JD., Fujii, CA., Utley, DS., et al.[2023]

The Pivot: Explore program, which combines a CO breath sensor, cigarette logging, and human coaching, showed high engagement levels among participants, with over 80% taking daily CO samples and more than 65% logging cigarettes regularly.

Participants reported significant improvements in their attitudes toward quitting smoking, with 78% indicating they reduced their daily cigarette consumption during the 9-day study, highlighting the program's potential effectiveness in promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comprehensive Digital Program for Smoking Cessation: Assessing Feasibility in a Single-Group Cohort Study. Patrick, H., Fujii, CA., Glaser, DB., et al.[2020]

Citations

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This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

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pharmacytimes.com/view/study-new-digital-tobacco-cessation-program-leads-to-44-quit-rate-of-smoking-compared-to-control-program

Study: New Digital Tobacco Cessation Program Leads to ...

Individuals who used Pivot Breathe, a digital tobacco cessation program made by Pivot, reached a 44% quit rate at 1 year and demonstrated ...

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Long-Term Outcomes of a Comprehensive Mobile Smoking ...

This pilot RCT supports the long-term effectiveness of the Pivot mobile smoking cessation program, with abstinence rates durable to 52 weeks.

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pmc.ncbi.nlm.nih.gov/articles/PMC6315234/

A Comprehensive Digital Program for Smoking Cessation

The Pivot app provides participants with a visual display of smoking trends, including information about number, time, and location of ...

7.

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Pivot: Build Better Habits

Randomized Controlled Trial Outcomes Show Pivot's Biovalidated Smoking Cessation Quit Rates Nearly Double that of Control Program from the National Cancer ...

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1 Outcomes from a Mobile Smoking Cessation Program ...

6.1 Data Collection and Confidentiality. Data collection will be electronically administered through participant input in the Pivot online.

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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.