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Remote Interventions for Menthol Cigarette Use

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07356297
Enrollment
1200
Registered
2026-01-21
Start date
2026-11-01
Completion date
2030-04-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cigarette Smoking

Brief 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.

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.

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.

Sponsors

University of Michigan
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Smoking Cessation3-, 6-, 9- and 12- months post baselineParticipants will self-report (yes/no) past 30-day combustible tobacco use.

Secondary

MeasureTime frameDescription
Smoking Cessation With Lapses3-, 6-, 9- and 12- months post baselineParticipants 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").

Contacts

CONTACTMegan Lavigne, BA
lavignem@med.umich.edu734-787-2059
CONTACTSimran Dhaliwal, BS
simrand@med.umich.edu734-395-0040
PRINCIPAL_INVESTIGATORLara Coughlin, PhD

University of Michigan

PRINCIPAL_INVESTIGATORErin Bonar, PhD

University of Michigan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026