Quitbot Program for Smoking Cessation

Overseen By Brie Sullivan

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Fred Hutchinson Cancer Research Center

Disqualifiers: Under 18, No smartphone, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

1647 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial compares two remote digital smoking cessation programs to see how well they work for quitting smoking.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot use other smoking cessation interventions while participating.

What data supports the effectiveness of the QuitBot Smoking Cessation Program treatment?

Research shows that computer-based smoking cessation programs, especially when combined with medication, can effectively help people quit smoking. Additionally, chat-bots have been studied for their potential to increase long-term nicotine abstinence rates, suggesting that the QuitBot program could be beneficial. ^{1 2 3 4 5}

How is the QuitBot Smoking Cessation Program different from other smoking cessation treatments?

The QuitBot Smoking Cessation Program is unique because it likely uses technology to provide personalized support for quitting smoking, which can be delivered on a large scale and at a low cost. This approach allows for individualized feedback and can be easily accessed online, making it more convenient and accessible compared to traditional face-to-face or telephone-based support. ^{1 6 7 8 9}

Research Team

Jonathan B Bricker

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

This trial is for smokers who have smoked at least one cigarette daily for the past year, want to quit within a month, and are willing to try a digital program. They must live in the US, read English, not use other cessation methods, be open to random assignment to either program, and have daily access to a smartphone with text messaging and Facebook Messenger.

Inclusion Criteria

Has at least daily access to their own smartphone

Not using other smoking cessation interventions (This eligibility requirement helps ensure results are due to the treatments we recommend rather than those that participants are doing on their own.)

I am 18 years old or older.

Exclusion Criteria

I do not meet the specific requirements listed for the trial.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants participate in the Quitbot program for 42 days to support quitting smoking

6 weeks

Follow-up

Participants are monitored for smoking cessation at 3, 6, and 12 months after treatment

12 months

Treatment Details

Interventions

• Control Smoking Cessation Program
• Experimental Smoking Cessation Program
• QuitBot Smoking Cessation Program
• Texting Smoking Cessation Program

Trial Overview The study compares two remote digital smoking cessation programs. Participants will receive support through their smartphones using either an experimental or control program designed to help them stop smoking.

Participant Groups

Group I: Group I (QuitBot Experimental) Experimental Treatment 1 Intervention

Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Group II: Group II (QuitBot Control) Active Control 1 Intervention

Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Research Center

Lead Sponsor

Trials

444

Recruited

148,000+

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

In a study involving 2,054 smokers from a Veterans Affairs Medical Center, various smoking cessation interventions were tested over 30 months, showing that stage-matched manuals alone achieved a cessation rate of 20.3%.

Adding nicotine replacement therapy (NRT) and other expert or automated counseling methods did not significantly improve cessation rates compared to the manuals alone, indicating that the effectiveness of these additional interventions may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. Velicer, WF., Friedman, RH., Fava, JL., et al.[2019]

This study is a randomized controlled trial involving 460 smokers, assessing the effectiveness of a chat-bot intervention for smoking cessation compared to usual treatment, with a focus on long-term nicotine abstinence validated by chemical testing at 6 months.

The research aims to provide evidence on the effectiveness of technology-based interventions in smoking cessation, potentially improving accessibility and adherence to treatment while ensuring patient safety through scientific validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). Avila-Tomas, JF., Olano-Espinosa, E., Minué-Lorenzo, C., et al.[2020]

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]

The minimal-contact smoking cessation program effectively engages smokers in both inpatient and outpatient settings by providing a brief consultation and a self-help kit, which includes exercises and a stop-smoking contract.

The program encourages compliance through weekly follow-up calls and incentives, such as lottery tickets, making it adaptable for various health care settings and practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A minimal-contact smoking cessation program in a health care setting. Strecher, VJ.[2018]

A personalized and automated Internet-based smoking cessation program (e-coaching) showed a higher cessation rate at 3 months compared to a control group receiving a smoking cessation booklet, with 27.5% of e-coaching participants abstaining versus 23.5% in the control group.

While the e-coaching program was effective in the short term, its superiority over the booklet diminished at 6 and 12 months, indicating that while it can provide immediate support, long-term effectiveness may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP). Nguyen Thanh, V., Guignard, R., Lancrenon, S., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Counselor and stimulus control enhancements of a stage-matched expert system intervention for smokers in a managed care setting. [2022]

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

Evaluating nicotine replacement therapy and stage-based therapies in a population-based effectiveness trial. [2019]

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

Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). [2020]

5. England pubmed.ncbi.nlm.nih.gov

A review of computer and Internet-based interventions for smoking behavior. [2022]

6. 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]

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

A minimal-contact smoking cessation program in a health care setting. [2018]

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

Using Diverse Communication Strategies to Re-Engage Relapsed Tobacco Quitline Users in Treatment, New York State, 2014. [2018]

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

Effectiveness of a Fully Automated Internet-Based Smoking Cessation Program: A Randomized Controlled Trial (STAMP). [2020]