An Innovative Conversational Agent (Quitbot) for Smoking Cessation

Overview

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

Full Title of Study: “Full Scale Randomized Trial of an Innovative Conversational Agent for Smoking Cessation (QuitBot)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2025

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Group I (QuitBot Experimental)
    • Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.
  • Active Comparator: Group II (QuitBot Control)
    • Participants participate in the Quitbot program for 42 days to support quitting smoking. Therapy description withheld to protect the integrity of the study.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with 30-day biochemically confirmed cigarette smoking cessation
    • Time Frame: 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 Measures

  • Number of participants with 30-day biochemically confirmed cigarette smoking cessation
    • Time Frame: 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Fred Hutchinson Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jonathan B. Bricker, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium

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