Smoking CessationNCT06111755
Quit Smoking Text Message Study
A study testing SmokefreeTXT and Smartband in people with Smoking Cessation, run by Yale University at 1 site in United States.
Trial summary
This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- SmokefreeTXT and Smartband
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- daily smokers for at least 6 months
- report an interest in quitting smoking.
Who cannot join
- reporting being currently enrolled in another quit smoking program
Trial locations and contacts
1 site in 1 country.
United States1 site
National online recruitment
New Haven, Connecticut, 06511
About this study
Official title: Evaluating Digital Health Interventions To Promote Smoking Cessation
This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.
Read the detailed description
Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.
Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.
Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.
- Conditions
- Smoking Cessation
- Being tested
- SmokefreeTXT, Smartband
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmokefreeTXTOther
National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.
SmartbandDevice
A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight.
| Study group | Role | What they receive |
|---|---|---|
| SmokefreeTXT | Active comparator | Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT. Receives: Other: SmokefreeTXT |
| SmokefreeTXT + smartband | Experimental | Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband. Receives: Other: SmokefreeTXT; Device: Smartband |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
7-day PPA at end of treatment with be confirmed via cotinine testing in saliva
Measured: 8 weeks
Secondary outcomes (4)
Change in cigarettes smoked per day
Change in average number cigarettes smoked per day by self report
Measured: baseline, 4 weeks and 8 weeks
Percent days smoke-free
Percentage of smoke-free days by self report
Measured: up to 8 weeks
Average number of days to relapse
Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date.
Measured: 2 weeks post quit date
Treatment satisfaction assessed using the Mobile Application Rating Scale User version
This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start26 Mar 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Lung Association
- Responsible party
- Sponsor
- Investigators
- Kathleen A Garrison, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111755
- Sponsor's protocol ID
- 2000035868
- Other IDs
- IA-1049344
- Status last verified
- Aug 2025
- First submitted
- 26 Oct 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Digital Health Interventions To Promote Smoking Cessation
- ClinicalTrials.gov ID
- NCT06111755
- Acronym / sponsor ID
- 2000035868
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Lung Association
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.
Detailed description
Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction.
Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.
Outcomes will be evaluated for those who complete enrollment, defined as those who complete study onboarding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SmokefreeTXT | Active comparator | Other: SmokefreeTXTDaily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT. |
| SmokefreeTXT + smartband | Experimental | Other: SmokefreeTXT, Device: SmartbandDaily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- daily smokers for at least 6 months
- report an interest in quitting smoking.
Key exclusion criteria (1 listed)
- reporting being currently enrolled in another quit smoking program
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 |
|---|---|---|
| SmokefreeTXTNational Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user. | Other | SmokefreeTXT, SmokefreeTXT + smartband |
| SmartbandA smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight. | Device | SmokefreeTXT + smartband |
Primary outcome
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks)
Time frame: 8 weeks
7-day PPA at end of treatment with be confirmed via cotinine testing in saliva
4 secondary outcomes
Change in cigarettes smoked per day
Time frame: baseline, 4 weeks and 8 weeks
Percent days smoke-free
Time frame: up to 8 weeks
Average number of days to relapse
Time frame: 2 weeks post quit date
Treatment satisfaction assessed using the Mobile Application Rating Scale User version
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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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.
Kathleen A Garrison, PhD principal investigator
Yale University
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 and Smartband in people with Smoking Cessation, run by Yale University 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 2 inclusion and 1 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 6 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2025.