ChatGPT-Supported Text Messaging Program for Smoking Cess... | NCT07079306

Studies
ChatGPT-Supported Text Messaging Program for Smoking Cessation

NCT07079306

Sponsor

George Washington University

Status

Not yet recruiting

Last Update Posted

May 22, 2026Actual

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Smoking Cessation

Interventions

BeFree+Bot
BeFree

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2026Estimated

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Jan 30, 2027Estimated

First Submitted Date

Jul 14, 2025

First Submission Date that Met QC Criteria

Jul 14, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current research proposal aims to explore how a purpose driven LLM ChatGPT chatbot, BeFreeBot, might enhance an evidence-based text messaging smoking cessation program, BeFree. The research will consist of a formative evaluation comparing quitting related outcomes among users of BeFree+Bot and BeFree.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Text messages about quitting smoking and access to specialized ChatGPT chatbot	Behavioral: BeFree+Bot
Control	Active Comparator	Text messages about quitting smoking	Behavioral: BeFree

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BeFree+Bot	Behavioral	Text messaging program called BeFree and access to BBot, ChatGPT chatbot	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Continuous abstinence	the longest continuous period (in days) that you did not smoke a cigarette	at 1 month follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

lives in the US
smoked a cigarette within the last 7 days
has a mobile phone
willing to receive text messages about the health effects of smoking on their mobile phone for 30 days

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lorien Abroms, ScD	Contact	202-994-3518		lorien@gwu.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prolific		Washington D.C.	District of Columbia	20052	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

It is a small pilot study

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016540	Smoking Cessation

Ancestor Terms

ID	Term
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided