Cigarette SmokingNCT07356297
Remote Interventions for Menthol Cigarette Use
A study testing Quitline (QL) and Mobile incentive-based intervention in people with Cigarette Smoking, run by University of Michigan.
Trial summary
The purpose of this study is to evaluate whether a digital, incentive-based program, used in conjunction with traditional quitline (QL) services, can be beneficial to quitline callers who smoke menthol cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Quitline (QL) and Mobile incentive-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adults (ages 18+) who call partnered quitlines (QL); and
- currently smoke menthol cigarettes; and
- are fluent in English; and
- plan to live in the United States for the full trial duration; and
- have daily smartphone access (including data access) or are willing to use a study-provided smartphone and data plan
- ability to provide informed consent
Who cannot join
- not ready to set a quit date within 30 days; or
- have not smoked in the past 7 days
- Inability to speak/understand English
- Conditions precluding informed consent or understanding of intervention or assessment content
- PI discretion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Remotely-delivered Interventions to Promote Cessation Among Adults Who Smoke Menthol Cigarettes
The purpose of this study is to evaluate whether a digital, incentive-based program, used in conjunction with traditional quitline (QL) services, can be beneficial to quitline callers who smoke menthol cigarettes. The services evaluated focus on coaching, support, and/or incentives for individuals who wish to quit smoking.
- Conditions
- Cigarette Smoking
- Being tested
- Quitline (QL), Mobile incentive-based intervention
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline (QL)Behavioural
QL services include scheduled and on-demand phone and digital interactions with a coach, as well as optional ancillary services and nicotine replacement therapy by mail.
Mobile incentive-based interventionBehavioural
The app-based intervention incentivizes participants for daily check-ins, smoking cessation, and QL calls. Participants also receive encouragement to set a smoking quit date from a study interventionist and receive motivational messages in the app.
| Study group | Role | What they receive |
|---|---|---|
| Quitline (QL) | Active comparator | Participants complete QL services Receives: Behavioral: Quitline (QL) |
| Quitline (QL) + App | Active comparator | Participants complete QL services and download our incentive-based mobile app Receives: Behavioral: Quitline (QL); Behavioral: Mobile incentive-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation
Participants will self-report (yes/no) past 30-day combustible tobacco use.
Measured: 3-, 6-, 9- and 12- months post baseline
Secondary outcomes (1)
Smoking Cessation With Lapses
Participants will self-report of cessation from combustible tobacco products, with the exception of up to 5 cigarettes (lapses), since 2 weeks after their quit date (i.e., 2 week "grace period").
Measured: 3-, 6-, 9- and 12- months post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Lara Coughlin, University of Michigan
- Investigators
- Lara Coughlin, PhD, Principal investigator, University of MichiganErin Bonar, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356297
- Sponsor's protocol ID
- HUM00275412
- Other IDs
- SU-2024C2-40036
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Consistent with sponsor requirements, de-identified data will be shared with the Patient Centered Outcomes Research Institute (PCORI), its collaborators, and associated research partners.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Remotely-delivered Interventions to Promote Cessation Among Adults Who Smoke Menthol Cigarettes
- ClinicalTrials.gov ID
- NCT07356297
- Acronym / sponsor ID
- HUM00275412
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 21 Jan 2026 (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.
The purpose of this study is to evaluate whether a digital, incentive-based program, used in conjunction with traditional quitline (QL) services, can be beneficial to quitline callers who smoke menthol cigarettes. The services evaluated focus on coaching, support, and/or incentives for individuals who wish to quit smoking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quitline (QL) | Active comparator | Behavioral: Quitline (QL)Participants complete QL services |
| Quitline (QL) + App | Active comparator | Behavioral: Quitline (QL), Behavioral: Mobile incentive-based interventionParticipants complete QL services and download our incentive-based mobile app |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults (ages 18+) who call partnered quitlines (QL); and
- currently smoke menthol cigarettes; and
- are fluent in English; and
- plan to live in the United States for the full trial duration; and
- have daily smartphone access (including data access) or are willing to use a study-provided smartphone and data plan
Key exclusion criteria (5 listed)
- not ready to set a quit date within 30 days; or
- have not smoked in the past 7 days
- Inability to speak/understand English
- Conditions precluding informed consent or understanding of intervention or assessment content
- PI discretion
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 |
|---|---|---|
| Quitline (QL)QL services include scheduled and on-demand phone and digital interactions with a coach, as well as optional ancillary services and nicotine replacement therapy by mail. | Behavioural | Quitline (QL), Quitline (QL) + App |
| Mobile incentive-based interventionThe app-based intervention incentivizes participants for daily check-ins, smoking cessation, and QL calls. Participants also receive encouragement to set a smoking quit date from a study interventionist and receive motivational messages in the app. | Behavioural | Quitline (QL) + App |
Primary outcome
Smoking Cessation
Time frame: 3-, 6-, 9- and 12- months post baseline
Participants will self-report (yes/no) past 30-day combustible tobacco use.
1 secondary outcome
Smoking Cessation With Lapses
Time frame: 3-, 6-, 9- and 12- months post baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Yes. Consistent with sponsor requirements, de-identified data will be shared with the Patient Centered Outcomes Research Institute (PCORI), its collaborators, and associated research partners.
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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.
Lara Coughlin, PhD principal investigator
University of Michigan
Erin Bonar, PhD principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Quitline (QL) and Mobile incentive-based intervention in people with Cigarette Smoking, run by University of Michigan.
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 6 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Lavigne, BA (734-787-2059, lavignem@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation (time frame: 3-, 6-, 9- and 12- months post baseline). 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 14 Sep 2026.