Remote Interventions for Menthol Cigarette Use

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cigarette Smoking
• Intervention / Treatment: Behavioral: Quitline (QL); Behavioral: Mobile incentive-based intervention

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Lavigne, BA; Phone Number: 734-787-2059; Email: lavignem@med.umich.edu
• Study Contact Backup: Name: Simran Dhaliwal, BS; Phone Number: 734-395-0040; Email: simrand@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quitline (QL); Participants complete QL services	Behavioral: 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.
Active Comparator: Quitline (QL) + App; Participants complete QL services and download our incentive-based mobile app	Behavioral: 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.; Behavioral: Mobile 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Participants will self-report (yes/no) past 30-day combustible tobacco use.	3-, 6-, 9- and 12- months post baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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").	3-, 6-, 9- and 12- months post baseline

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Lara Coughlin, PhD, University of Michigan; Principal Investigator: Erin Bonar, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Smoking; Tobacco Use; Cigarette Smoking
• Other Study ID Numbers: HUM00275412; SU-2024C2-40036 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Consistent with sponsor requirements, de-identified data will be shared with the Patient Centered Outcomes Research Institute (PCORI), its collaborators, and associated research partners.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No