Tobacco SmokingA2QNCT04720625
Adapt2Quit - An Adaptive Motivational System for Socio-Economically Disadvantaged Smokers
A study testing Adapt2Quit in people with Tobacco Smoking, run by University of Massachusetts, Worcester at 3 sites in United States.
Trial summary
The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Adapt2Quit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 757 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Jun 2021to 31 Mar 2025
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smoker
- Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
- English-speaking
- Active in care (at least two clinical visits in the last year)
- Have a texting-enabled cell phone
Who cannot join
- Not a current smoker
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
- Pilot study participants
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Baystate Health
Springfield, Massachusetts, 01199
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers
The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.
Read the detailed description
The Adapt2Quit trial (NCT04720625) is a randomized controlled trial testing a machine-learning-driven text messaging system aimed at increasing smoking cessation rates among socioeconomically disadvantaged adults.
The 6-month study compares an adaptive, personalized motivational messaging intervention against standard Quitline facilitation, utilizing AI to select tailored behavioral prompts based on user feedback.
- Conditions
- Tobacco Smoking
- Being tested
- Adapt2Quit, Control
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapt2QuitBehavioural
Motivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages.
ControlBehavioural
Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
| Study group | Role | What they receive |
|---|---|---|
| Adapt2Quit | Experimental | These participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months. Receives: Behavioral: Adapt2Quit |
| Control | Active comparator | These participants will receive quitline facilitation-only messaging for 6 months. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor. Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of >6 ppm were classified as tobacco users.
Measured: 6-months post-randomization
Secondary outcomes (1)
Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months
Self-reported cigarette abstinence was assessed at the 6-month follow-up using the question: "Do you currently smoke cigarettes, even one puff in the last 7 days?" Participants who answered "No" were classified as self-reported abstinent.
Measured: 6-months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start28 Jun 2021
- Primary completion10 Oct 2024
- Study completion31 Mar 2025
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 Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 757 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Johns Hopkins University, Baystate Health
- Responsible party
- Principal investigator, Rajani Sadasivam, University of Massachusetts, Worcester
- Investigators
- Rajani Sadasivam, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720625
- Sponsor's protocol ID
- H00018991
- Other IDs
- 1R01CA240551-01A1
- Acronym
- A2Q
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2021
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kamberi A, Weitz B, Flahive J, Eve J, Najjar R, Liaghat T, Ford D, Lindenauer P, Person S, Houston TK, Gauvey-Kern ME, Lobien J, Sadasivam RS, Balakrishnan K. Testing a Machine Learning-Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 16;14:e63693. doi: 10.2196/63693.
PubMed 40239194
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapt2Quit - A Machine-Learning, Adaptive Motivational System: RCT for Socio-Economically Disadvantaged Smokers
- ClinicalTrials.gov ID
- NCT04720625
- Acronym / sponsor ID
- A2Q / H00018991
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 757 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI), Johns Hopkins University, Baystate Health
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Posted 31 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to test the Adapt2Quit computer program that uses participant input (message rating on how much the text motivational message might influence one to quit smoking) to select and text motivational messages that are more likely to help a user stop smoking. This Adapt2Quit system will be compared with a quitline facilitation-only control (text messages will be sent to facilitate quitline use). The primary research hypothesis is that the Adapt2Quit recommender-selected messages will be more effective than a texting quitline facilitation-only control for smoking cessation among socioeconomically disadvantaged (SED) smokers.
Detailed description
The Adapt2Quit trial (NCT04720625) is a randomized controlled trial testing a machine-learning-driven text messaging system aimed at increasing smoking cessation rates among socioeconomically disadvantaged adults.
The 6-month study compares an adaptive, personalized motivational messaging intervention against standard Quitline facilitation, utilizing AI to select tailored behavioral prompts based on user feedback.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapt2Quit | Experimental | Behavioral: Adapt2QuitThese participants will receive Adapt2Quit motivational messaging and quitline facilitation messaging for 6 months. |
| Control | Active comparator | Behavioral: ControlThese participants will receive quitline facilitation-only messaging for 6 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current smoker
- Socioeconomically disadvantaged (SED) (using the following criteria: unemployed or underemployed, low income as defined by the federal poverty level guidelines, uninsured or underinsured, and/or have less than a high school education)
- English-speaking
- Active in care (at least two clinical visits in the last year)
- Have a texting-enabled cell phone
Key exclusion criteria (6 listed)
- Not a current smoker
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
- Pregnant women
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 |
|---|---|---|
| Adapt2QuitMotivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages. | Behavioural | Adapt2Quit |
| ControlQuitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages. | Behavioural | Control |
Primary outcome
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months
Time frame: 6-months post-randomization
Participants who self-reported no tobacco use in the past 7 days at the 6-month follow-up underwent biochemical verification using the CoVita Smokerlyzer breath carbon monoxide (CO) monitor. Participants with a CO measurement of ≤6 ppm were classified as abstinent; those with a CO measurement of >6 ppm were classified as tobacco users.
1 secondary outcome
Number of Participants With Self-Reported 7-Day Point Prevalence Cigarette Abstinence at 6 Months
Time frame: 6-months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40239194Kamberi A, Weitz B, Flahive J, Eve J, Najjar R, Liaghat T, Ford D, Lindenauer P, Person S, Houston TK, Gauvey-Kern ME, Lobien J, Sadasivam RS, Balakrishnan K. Testing a Machine Learning-Based Adaptive Motivational System for Socioeconomically Disadvantaged Smokers (Adapt2Quit): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 16;14:e63693. doi: 10.2196/63693.
- Individual participant dataSharing planned: No
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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.
Rajani Sadasivam, PhD principal investigator
Associate Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapt2Quit in people with Tobacco Smoking, run by University of Massachusetts, Worcester at 3 sites 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 6 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 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 31 Jul 2026). 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?
Number of Participants With Biochemically Verified 7-Day Point Prevalence Tobacco Abstinence at 6 Months (time frame: 6-months post-randomization). 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 NCT04720625, 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 31 Jul 2026.