Smoking CessationNCT05055778
Establishing the Effectiveness of Publicly Available Smoking Cessation Resource
A study testing SmokefreeTXT in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SmokefreeTXT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22904
About this study
Official title: Establishing the Effectiveness of Publicly Available Smoking Cessation Resources: Does Rurality Matter?
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.
- Conditions
- Smoking Cessation
- Being tested
- SmokefreeTXT
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokefreeTXTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SmokfreeTXT | Experimental | Research version of the publicly available SmokefreeTXT program Receives: Behavioral: SmokefreeTXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 3 months
Secondary outcomes (4)
Self-reported Continuous Abstinence
Continuous abstinence, 6 weeks after initiating the quit attempt (Question wording: In the last 6 weeks, have you smoked at all? Response options: Yes; No; Not sure)
Measured: 7 weeks after study start
Self-reported Continuous Abstinence
Continuous abstinence 3 months after initiating the quit attempt (Question wording: In the last 3 months, have you smoked at all? Response options: Yes; No; Not sure)
Measured: 3 months
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)
Measured: 6 months
Self-reported Continuous Abstinence
Continuous abstinence 6 months after initiating the quit attempt (Question wording: In the last 6 months, have you smoked at all? Response options: Yes; No; Not sure)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start3 Nov 2021
- Primary completion6 Feb 2024
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara Wiseman, MPH, PhD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055778
- Sponsor's protocol ID
- 3928
- Status last verified
- Feb 2025
- First submitted
- 16 Aug 2021
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, a de-identified dataset will be available to other researchers after the study is completed.
Publications
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.
PubMed 41257752
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Effectiveness of Publicly Available Smoking Cessation Resources: Does Rurality Matter?
- ClinicalTrials.gov ID
- NCT05055778
- Acronym / sponsor ID
- 3928
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 6 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 24 Sep 2021 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmokfreeTXT | Experimental | Behavioral: SmokefreeTXTResearch version of the publicly available SmokefreeTXT program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmokefreeTXTThe 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. | Behavioural | SmokfreeTXT |
Primary outcome
Self-reported Smoking Cessation
Time frame: 7 weeks after study start
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)
Self-reported Smoking Cessation
Time frame: 3 months
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)
4 secondary outcomes
Self-reported Continuous Abstinence
Time frame: 7 weeks after study start
Self-reported Continuous Abstinence
Time frame: 3 months
Self-reported Smoking Cessation
Time frame: 6 months
Self-reported Continuous Abstinence
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41257752Kinchen 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.
- Individual participant dataSharing planned: Yes. If requested, a de-identified dataset will be available to other researchers after the study is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmokefreeTXT in people with Smoking Cessation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Smoking Cessation (time frame: 7 weeks after study start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05055778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.