Digital Cessation Program for Quitting Smoking

Overseen By Managing Director, Research

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Truth Initiative

Disqualifiers: Age 25 or above

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

2220 Participants Needed

Trial Summary

What is the purpose of this trial?

The Cessation Clinical Trial will investigate the effectiveness of a digital quit tobacco program in promoting abstinence from tobacco product use compared to usual care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Truth Initiative Digital Cessation Program treatment for quitting smoking?

Research on similar digital smoking cessation programs, like Pivot and CASC, shows that using a smartphone app with features like a carbon monoxide breath sensor and coaching can significantly improve quitting rates compared to standard treatments. These programs have been effective in helping people quit smoking by providing accessible and engaging support. ^{1 2 3 4 5}

Is the Digital Cessation Program for Quitting Smoking safe for humans?

There is no specific safety data available for the Digital Cessation Program for Quitting Smoking, but general safety reporting in clinical trials often lacks detailed information on adverse effects. It's important for trials to systematically collect and report safety data to ensure participant safety. ^{6 7 8 9 10}

How is the Truth Initiative Digital Cessation Program different from other smoking cessation treatments?

The Truth Initiative Digital Cessation Program is unique because it combines a smartphone app, a carbon monoxide breath sensor, and text-based human coaching to help people quit smoking. This digital approach allows for personalized support and feedback, making it more accessible and engaging compared to traditional methods. ^{2 3 11 12 13}

Eligibility Criteria

This trial is for tobacco users in the US who've used products like cigarettes or e-cigarettes in the last 30 days. They must have an active text message plan for phase 2 of the study. However, individuals aged 25 or above are excluded from phase 2.

Inclusion Criteria

Current tobacco use (past 30-day use of one or more of the following: cigarettes, cigars, little cigars, cigarillos, e-cigarettes, or oral nicotine products)

US residence

Active text message plan (phase 2 only)

Exclusion Criteria

I am 25 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a digital quit tobacco program or usual care for tobacco cessation

7 months

Follow-up

Participants are monitored for 30-day point prevalent abstinence and abstinence from all tobacco products

7 months

Treatment Details

Interventions

• Truth Initiative Digital Cessation Program

Trial Overview The trial is testing a digital program designed to help people quit using tobacco against what's normally done (usual care). Participants will either use this new digital tool or continue with standard support methods to see which helps more with quitting.

Participant Groups

Group I: Sponsored cessation intervention Experimental Treatment 1 Intervention

Intervention arm receiving sponsored version only available for enterprise client users.

Group II: Free cessation intervention Experimental Treatment 1 Intervention

Intervention arm receiving free version of a cessation intervention.

Group III: Usual Care Active Control 1 Intervention

Usual care control arm receiving referral to a free digital cessation program

Group IV: Assessment-only Active Control 1 Intervention

Periodic assessment check-ins only, no active intervention

Who Is Running the Clinical Trial?

Truth Initiative

Lead Sponsor

Trials

20

Recruited

32,000+

Findings from Research

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 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]

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]

In a study involving 584 participants, the CureApp Smoking Cessation (CASC) system, which includes a smartphone app and a mobile CO checker, significantly improved the continuous abstinence rate (CAR) from smoking compared to a control app, with rates of 63.9% versus 50.5% from weeks 9 to 24.

The CASC system also showed a higher CAR from weeks 9 to 52 (52.3% vs. 41.5%), indicating its effectiveness in supporting long-term smoking cessation without any reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. Masaki, K., Tateno, H., Nomura, A., et al.[2023]

Computer-based smoking cessation programs are effective and can be delivered on a large scale at a low cost, making them accessible to many smokers.

These programs work best when combined with pharmacotherapy and can serve as a helpful addition to counseling provided by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. Etter, JF.[2017]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.

To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. Ioannidis, JP., Lau, J.[2018]

In 2011, the MedWatch system received 600,000 adverse event reports, highlighting its role in improving drug and device safety awareness, but it also faces challenges with reporting bias and data accuracy.

A study analyzing 10.2 million reports found that while patient information was mostly accurate, suspect product data was often incomplete or incorrect, with significant gaps in key details like dosage and product lot numbers, which could lead to incorrect conclusions about drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the completeness and accuracy of MedWatch data. Getz, KA., Stergiopoulos, S., Kaitin, KI.[2017]

The NCI developed a software tool to collect patient-reported adverse events in clinical trials, which underwent iterative usability testing with 169 patients and 47 professionals to enhance its functionality.

Modifications based on user feedback improved the software's usability, leading to significant enhancements in task performance for professionals, indicating that the tool is now effectively used in multiple cancer clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. Schoen, MW., Basch, E., Hudson, LL., et al.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The Web-based smoking cessation program significantly improved short-term smoking abstinence rates at 6 weeks, with odds ratios indicating higher chances of quitting compared to the control group (e.g., 24-hour abstinence OR 1.85).

However, after 6 months, the program did not show sustained effects on smoking cessation, suggesting that while it may help in the short term, further strategies are needed to maintain long-term abstinence and address participant attrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers. Smit, ES., de Vries, H., Hoving, C.[2022]

A scoping review of 82 studies on remote biochemical verification of smoking status found that the most common methods used were expired air and saliva samples, with carbon monoxide and cotinine as the primary biomarkers.

The study revealed that self-reported abstinence rates were significantly higher (21%) than biochemically verified rates (10%), indicating potential misreporting or challenges in sample return, highlighting the need for improved strategies in remote verification methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review and Meta-analysis of the Use of Remote Biochemical Verification Methods of Smoking Status in Tobacco Research. Thrul, J., Howe, CL., Devkota, J., 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]

References

1. 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]

2. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a smoking cessation smartphone application with a carbon monoxide checker. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Using new information technology to treat tobacco dependence. [2017]

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

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. [2016]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Improving safety reporting from randomised trials. [2018]

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

Evaluating the completeness and accuracy of MedWatch data. [2017]

9. Canada pubmed.ncbi.nlm.nih.gov

Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

11. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a Web-based multiple tailored smoking cessation program: a randomized controlled trial among Dutch adult smokers. [2022]

12. England pubmed.ncbi.nlm.nih.gov

A Scoping Review and Meta-analysis of the Use of Remote Biochemical Verification Methods of Smoking Status in Tobacco Research. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

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