Remote Interventions for Menthol Cigarette Use

NCT07356297 — Not applicable, Not yet recruiting, 1200 participants, University of Michigan

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Comparing Remotely-delivered Interventions to Promote Cessation Among Adults Who Smoke Menthol Cigarettes

Registry	NCT07356297
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	1200 (Estimated)
Sponsor	University of Michigan (Other); collaborators: Patient-Centered Outcomes Research Institute
Conditions	Cigarette Smoking
Interventions	Quitline (QL), Mobile incentive-based intervention (Behavioral)
Dates	start 2026-11-01 (estimated), primary completion 2030-04-01 (estimated), completion 2030-04-01 (estimated), first posted 2026-01-21, last updated 2026-09-14

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Quitline (QL)	Active comparator	Behavioral: Quitline (QL)	Participants complete QL services
Quitline (QL) + App	Active comparator	Behavioral: Quitline (QL); Behavioral: Mobile incentive-based intervention	Participants complete QL services and download our incentive-based mobile app

Quitline (QL) (Behavioral): 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 intervention (Behavioral): 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.

+Outcome measures

Primary outcomes

Smoking Cessation [3-, 6-, 9- and 12- months post baseline]: Participants will self-report (yes/no) past 30-day combustible tobacco use.

Secondary outcomes

Smoking Cessation With Lapses [3-, 6-, 9- and 12- months post baseline]: 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").

+Eligibility

Sex: All, ages: 18 Years to any

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 informed consent

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 informed consent or understanding of intervention or assessment content
* PI discretion

+Investigators

Lara Coughlin, PhD, Principal investigator, University of Michigan
Erin Bonar, PhD, Principal investigator, University of Michigan