An Innovative Conversational Agent (Quitbot) for Smoking Cessation

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

Detailed Description
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OUTLINE: Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program. GROUP I: Experimental program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months. GROUP II: Control program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Official Title
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Full Scale Randomized Trial of an Innovative Conversational Agent for Smoking Cessation (QuitBot)

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Other: Experimental Smoking Cessation Program
* Other: Control Smoking Cessation Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Smokes at least one cigarette a day for the past 12 months Wants to quit cigarette smoking within the next 30 days (consistent with text messaging intervention trials) If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days Interested in learning skills to quit smoking Willing to be randomly assigned to either intervention Resides in United States (US) and will continue to reside in the US for the next 12 months Has at least daily access to their own smartphone Has text messaging on their smartphone and knows how to download a smartphone application Willing and able to read in English, and 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.) Exclusion Criteria: The reverse of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (QuitBot Experimental)<br>Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study. | Other: Experimental Smoking Cessation Program<br>* Participate in Quitbot experimental cessation program<br>* Other names: Experimental;|
| Active Comparator: Group II (QuitBot Control)<br>Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study. | Other: Control Smoking Cessation Program<br>* Participate in Quitbot control cessation program<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with 30-day biochemically confirmed cigarette smoking cessation | No smoking at all in the past 30 or more days. Complete the biochemical verification procedure that is mailed (Alere saliva-based smoking cessation verification test). | At 12 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with 30-day biochemically confirmed cigarette smoking cessation | No smoking at all in the past 30 or more days. Complete the biochemical verification procedure that is mailed (Alere saliva-based smoking cessation verification test). | At 3 and 6 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, smoking cessation, quitting smoking, chatbot