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Completed

NCT Number: NCT04308759

An Innovative Conversational Agent (Quitbot) for Smoking Cessation

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

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Key information

Conditions

Smoking &Amp; Tobacco Cessation Behavior Health Behavior Smoking Smoking Cessation Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

OUTLINE:

Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program.

GROUP I: Experimental QuitBot chatbot 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 SmokefreeTXT text messaging program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Smoking Cessation Program

Other

Participate in Quitbot experimental cessation program

Other names: Experimental

Control Smoking Cessation Program

Other

Participate in Quitbot control cessation program

Other names: Control

Primary outcomes

  1. Number of Participants With 30-day Cigarette Smoking Cessation

    Time frame: At 12 months after randomization

    The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 12 months post-randomization. At 12 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.

Secondary outcomes

  1. Number of Participants With 30-day Cigarette Smoking Cessation

    Time frame: At 6 months after randomization

    The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 6 months post-randomization. At 6 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 16, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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