NCT04308759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,647

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
2.4 years until next milestone

Study Start

First participant enrolled

July 24, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2026

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

March 6, 2020

Results QC Date

March 19, 2026

Last Update Submit

May 20, 2026

Conditions

Smoking &Amp; Tobacco Cessation

Keywords

Smokingsmoking cessationquitting smokingchatbot

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With 30-day Cigarette Smoking Cessation

    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.

    At 12 months after randomization

Secondary Outcomes (1)

  • Number of Participants With 30-day Cigarette Smoking Cessation

    At 6 months after randomization

Study Arms (2)

Group I (QuitBot Experimental)

EXPERIMENTAL

Participants participate in the QuitBot program for 42 days to support quitting smoking. QuitBot is a novel chatbot smartphone application for smoking cessation.

Other: Experimental Smoking Cessation Program

Group II (SmokefreeTXT Control)

ACTIVE COMPARATOR

Participants participate in the SmokefreeTXT program for 42 days to support quitting smoking. SmokefreeTXT is a standard of care smoking cessation text messaging program from the NCI.

Other: Control Smoking Cessation Program

Interventions

Experimental Smoking Cessation ProgramOTHER

Participate in Quitbot experimental cessation program

Also known as: Experimental
Group I (QuitBot Experimental)
Control Smoking Cessation ProgramOTHER

Participate in Quitbot control cessation program

Also known as: Control
Group II (SmokefreeTXT Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • 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.

    PMID: 39490766BACKGROUND

MeSH Terms

Conditions

SmokingTobacco Use CessationSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Results Point of Contact

Title
Dr. Jonathan Bricker
Organization
Fred Hutchinson Cancer Center
jbricker@fredhutch.org
206-667-5074

Study Officials

  • Jonathan B. Bricker

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 16, 2020

Study Start

July 24, 2022

Primary Completion

May 1, 2025

Study Completion

April 8, 2026

Last Updated

May 22, 2026

Results First Posted

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)