NCT07079306

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

July 14, 2025

Last Update Submit

May 20, 2026

Conditions

Smoking Cessation

Keywords

smoking cessationaitext messaging

Outcome Measures

Primary Outcomes (1)

  • Continuous abstinence

    the longest continuous period (in days) that you did not smoke a cigarette

    at 1 month follow-up

Study Arms (2)

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

BeFree+BotBEHAVIORAL

Text messaging program called BeFree and access to BBot, ChatGPT chatbot

Intervention
BeFreeBEHAVIORAL

Text messaging program called BeFree

Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prolific

Washington D.C., District of Columbia, 20052, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Lorien Abroms, ScD

CONTACT

202-994-3518lorien@gwu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 23, 2025

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

It is a small pilot study

Locations

US(1)