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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the Pivot smoking cessation treatment?

Research shows that the Pivot program, which includes a smartphone app, a breath sensor, and coaching, is based on proven methods and has shown promising results in helping people quit smoking. Studies have reported positive outcomes in both short-term and longer-term follow-ups, indicating its potential effectiveness. ^{1 2 3 4 5}

Is the Pivot smoking cessation program safe for humans?

The Pivot smoking cessation program, which includes a smartphone app, a carbon monoxide breath sensor, and coaching, has been evaluated in several studies. The carbon monoxide breath sensor used in the program is cleared by the Food and Drug Administration (FDA), indicating it meets safety standards for use. ^{1 2 3 4 6}

How does the Pivot smoking cessation treatment differ from other treatments?

The Pivot smoking cessation program is unique because it combines a smartphone app, a personal carbon monoxide breath sensor, and text-based human coaching, making it a comprehensive digital solution. This approach leverages technology to provide personalized support and engagement, which is different from traditional methods that may not include these digital components. ^{1 2 3 4 7}

What is the purpose of this trial?

Prospective, open label, single center clinical study enrolling up to 120 participants to evaluate the Pivot cigarette smoking cessation program in adult smokers, previously unable to quit, who also use other smoke-free nicotine product(s) (poly-use) and wish to stop cigarette smoking by switching to these smoke-free nicotine products.

Research Team

Jennifer Marler, MD

Principal Investigator

Pivot Health Technologies Inc.

Eligibility Criteria

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 currently use at least one smoke-free nicotine product.

Has daily internet access on smartphone

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

Exclusion Criteria

Pregnant or breast-feeding

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

Smokes marijuana ≥ 4 days per week

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

References

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

Outcomes of a Comprehensive Mobile Smoking Cessation Program With Nicotine Replacement Therapy in Adult Smokers: Pilot Randomized Controlled Trial. [2022]

2. Canada 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. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

A Comprehensive Digital Program for Smoking Cessation: Assessing Feasibility in a Single-Group Cohort Study. [2020]

4. Canada 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. [2023]

5. Canada 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. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

Assessment of a Personal Interactive Carbon Monoxide Breath Sensor in People Who Smoke Cigarettes: Single-Arm Cohort Study. [2021]

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

Smiling Instead of Smoking: Development of a Positive Psychology Smoking Cessation Smartphone App for Non-daily Smokers. [2021]