An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Phase 3

Active, not recruiting

• Conditions: Cigarette Smoking-Related Carcinoma
• Interventions: Other: Control Smoking Cessation Program; Other: Experimental Smoking Cessation Program

• Registration Number: NCT04308759
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-16
• Study Start: 2022-07-24
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1647

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (QuitBot Control)	Control Smoking Cessation Program	Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.
Group I (QuitBot Experimental)	Experimental Smoking Cessation Program	Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Primary Outcome Measures

Name	Time	Method
Number of participants with 30-day biochemically confirmed cigarette smoking cessation	At 12 months after randomization	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).

Secondary Outcome Measures

Name	Time	Method
Number of participants with 30-day biochemically confirmed cigarette smoking cessation	At 3 and 6 months after randomization	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).

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States