An Innovative Conversational Agent (Quitbot) for Smoking Cessation

NCT ID: NCT04308759

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1647 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-24

Study Completion Date

2026-05-01

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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental Smoking Cessation Program

Intervention Type OTHER

Participate in Quitbot experimental cessation program

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.

Group Type ACTIVE_COMPARATOR

Control Smoking Cessation Program

Intervention Type OTHER

Participate in Quitbot control cessation program

Interventions

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Experimental Smoking Cessation Program

Participate in Quitbot experimental cessation program

Intervention Type OTHER

Control Smoking Cessation Program

Participate in Quitbot control cessation program

Intervention Type OTHER

Other Intervention Names

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Experimental Control

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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan B. Bricker

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Bricker JB, Sullivan BM, Mull KE, Lavista-Ferres J, Santiago-Torres M. Efficacy of a conversational chatbot for cigarette smoking cessation: Protocol of the QuitBot full-scale randomized controlled trial. Contemp Clin Trials. 2024 Dec;147:107727. doi: 10.1016/j.cct.2024.107727. Epub 2024 Oct 28.

Reference Type DERIVED
PMID: 39490766 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2020-00136

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1006844

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA247156

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10359

Identifier Type: OTHER

Identifier Source: secondary_id

RG1006844

Identifier Type: -

Identifier Source: org_study_id

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