ClinicalTrials.gg
Not yet recruitingNCT07356297Updated Nov 9, 2026

Remote Interventions for Menthol Cigarette Use

An interventional study of Quitline (QL) and Mobile incentive-based intervention in Cigarette Smoking, sponsored by University of Michigan. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Updated Nov 9, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. The services evaluated focus on coaching, support, and/or incentives for individuals who wish to quit smoking.

02

Conditions studied

  • Cigarette Smoking

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03

In context

Cigarette Smoking

475 studies on the registry are indexed under Cigarette Smoking; 86 are open to participants now.

This study's planned enrollment of 1,200 is above the median of 96 across 406 interventional studies indexed under Cigarette Smoking.

Browse Cigarette Smoking studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 or understanding of intervention or assessment content
  • PI discretion
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
1,200 participants (estimated)

Study arms

  • Active comparator
    Quitline (QL)

    Participants complete QL services

    Behavioral: Quitline (QL)

  • Active comparator
    Quitline (QL) + App

    Participants complete QL services and download our incentive-based mobile app

    Behavioral: Quitline (QL) · Behavioral: Mobile incentive-based intervention

Interventions

  • BehavioralQuitline (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.

  • BehavioralMobile incentive-based intervention

    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.

06

What researchers measure

Primary outcomes

  1. Smoking Cessation

    Participants will self-report (yes/no) past 30-day combustible tobacco use.

    Time frame: 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").

    Time frame: 3-, 6-, 9- and 12- months post baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Nov 2026→Dec 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Start date Nov 2026→Dec 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07356297
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Lara Coughlin (Principal Investigator, University of Michigan) — Principal investigator
First posted
Jan 21, 2026
Start date
Dec 2026 (estimated)
Primary completion
Apr 2030 (estimated)
Completion
Apr 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Megan Lavigne, BA
Contact
lavignem@med.umich.edu
734-787-2059
Simran Dhaliwal, BS
Contact
simrand@med.umich.edu
734-395-0040
Lara Coughlin, PhD
principal investigator · University of Michigan
Erin Bonar, PhD
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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