An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04308759
• Other study ID #: RG1006844
• Secondary ID: NCI-2020-00136RG
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 24, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1647
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Other:
• Experimental Smoking Cessation Program
Participate in Quitbot experimental cessation program
• Control Smoking Cessation Program
Participate in Quitbot control cessation program

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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