NCT05055778

Brief Summary

The purpose of this study is to evaluate the effectiveness of SmokefreeTXT, a smoking cessation text messaging program currently available to anyone in the United States through www.smokefree.gov, and to compare cessation outcomes for smokers living in different regions of Virginia while participants use the program. Participants will be asked to complete assessments at Baseline, 7 weeks, 3 months, and 6 months and will be asked to use a research version of SmokefreeTXT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration 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

August 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 3, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 3, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

August 16, 2021

Results QC Date

February 3, 2025

Last Update Submit

February 3, 2025

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

  • Self-reported Smoking Cessation

    7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No)

    7 weeks after study start

  • Self-reported Smoking Cessation

    7-day point prevalence of abstinence (Question wording: Have you smoked a cigarette (even a puff) in the past 7 days? Response options: Yes; No)

    3 months

Secondary Outcomes (4)

  • Self-reported Continuous Abstinence

    7 weeks after study start

  • Self-reported Continuous Abstinence

    3 months

  • Self-reported Smoking Cessation

    6 months

  • Self-reported Continuous Abstinence

    6 months

Study Arms (1)

SmokfreeTXT

EXPERIMENTAL

Research version of the publicly available SmokefreeTXT program

Behavioral: SmokefreeTXT

Interventions

SmokefreeTXTBEHAVIORAL

The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting "keywords" to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings.

SmokfreeTXT

Eligibility Criteria

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

You may qualify if:

  • Age 18 and over
  • Current cigarette smoker (has smoked at least 100 cigarettes in their lifetime and currently smokes)
  • Ability to read and speak English
  • Resident of Virginia
  • Owns a cell phone

You may not qualify if:

  • Not a current smoker (e.g., started a quit attempt between providing interest information and starting the study)
  • Identity not able to be verified from information provided on interest form
  • Does not own a cell phone
  • Pregnant smoker or may become pregnant in the next 6 months
  • Lives in an area that has met recruitment criteria (after recruitment has begun)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

  • Kinchen JW, Little MA, Ritterband LM, Wiseman KP. Pilot study examining the effect of rurality on engagement and abstinence for adult users of a text-message cessation intervention. BMC Public Health. 2025 Nov 19;25(1):4061. doi: 10.1186/s12889-025-25284-6.

    PMID: 41257752DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Kara P. Wiseman, MPH, PhD
Organization
University of Virginia
kara.wiseman@virginia.edu
434-243-8126

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Public Health Sciences

Study Record Dates

First Submitted

August 16, 2021

First Posted

September 24, 2021

Study Start

November 3, 2021

Primary Completion

February 6, 2024

Study Completion

February 6, 2024

Last Updated

March 3, 2025

Results First Posted

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

If requested, a de-identified dataset will be available to other researchers after the study is completed.

Shared Documents
STUDY PROTOCOL
Time Frame
After study completion

Locations

US(1)