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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of two remote digital programs in helping people quit smoking. Participants will use the QuitBot Smoking Cessation Program for 42 days, with one group testing an experimental version and the other a control version. It suits individuals who have smoked at least one cigarette daily for the past year, wish to quit within the next 30 days, and own a smartphone with text messaging capabilities. As a Phase 3 trial, this study represents the final step before potential FDA approval, providing participants an opportunity to contribute to a treatment that could soon become widely available.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the QuitBot Smoking Cessation Program has been tested in earlier studies. QuitBot effectively helps people quit smoking and keeps users engaged. While these studies primarily focus on its effectiveness, they have not identified any major safety issues, suggesting that users generally tolerate the program well. As this trial is in a later stage, the treatment has already passed initial safety checks with people. It is considered safe enough for testing on larger groups, which typically indicates fewer risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

The Quitbot Program for Smoking Cessation is unique because it leverages digital therapy to help people quit smoking. Unlike traditional methods like nicotine replacement therapy or medications like varenicline, Quitbot offers a tech-driven approach that may provide personalized support and interaction. Researchers are excited about this trial as it could demonstrate how digital solutions can complement or even enhance current smoking cessation strategies by offering a more engaging and accessible way for individuals to kick the habit.

What evidence suggests that this trial's smoking cessation programs could be effective?

Research shows that QuitBot, a digital program designed to help people stop smoking, has promising results. An initial study found that QuitBot kept users engaged and helped many quit smoking. Specifically, 96% of participants continued using the program for three months, indicating strong adherence. In this trial, researchers will assign participants to different groups to evaluate the effectiveness of the QuitBot program. Programs like QuitBot can be effective, especially when combined with medication. Overall, early results suggest that QuitBot could be a useful tool for those wanting to quit smoking. ^{1 3 4 6 7}

Who Is on the Research Team?

Jonathan B Bricker

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

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.)

Smokes at least one cigarette a day for the past 12 months

Exclusion Criteria

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39490766/

Protocol of the QuitBot full-scale randomized controlled trial We developed QuitBot, a quit smoking program of two to three-minute conversations covering topics ranging from motivations to quit, setting a quit date, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424003100

Protocol of the QuitBot full-scale randomized controlled trial The pilot RCT proved feasible, achieving a 96 % retention rate for outcome data at 3 months. QuitBot showed strong user engagement and promising cessation rates ...

3. mhealth.jmir.org mhealth.jmir.org/2024/1/e57318/

Conversational Chatbot for Cigarette Smoking Cessation In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared ...

4. withpower.com withpower.com/trial/phase-3-10-2021-4afd6

Quitbot Program for Smoking Cessation · Info for Participants Research shows that computer-based smoking cessation programs, especially when combined with medication, can effectively help people quit smoking. Additionally ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38913882/

Conversational Chatbot for Cigarette Smoking Cessation In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11303891/

Conversational Chatbot for Cigarette Smoking Cessation In a pilot RCT with 96% three-month outcome data retention, QuitBot demonstrated high user engagement and promising cessation rates compared to the National ...

7. aha.org aha.org/role-hospitals-fred-hutchinson-cancer-center-ai-quitbot

One hospital's quest to beat smoking, with a little help from AI QuitBot guides users through the process of quitting through specially trained AI, which engages with users through quitting-related conversations and provides ...