Remote Interventions for Menthol Cigarette Use

NCT07356297 | Not Yet Recruiting

• 2 other identifiers: HUM00275412SU-2024C2-40036
• Study Type: interventional
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

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

  3-, 6-, 9- and 12- months post baseline

Secondary Outcomes (1)

• Smoking Cessation With Lapses

  3-, 6-, 9- and 12- months post baseline

Study Arms (2)

Quitline (QL)

ACTIVE COMPARATOR

Participants complete QL services

Behavioral: Quitline (QL)

Quitline (QL) + App

ACTIVE COMPARATOR

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

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

Interventions

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.

Quitline (QL); Quitline (QL) + App

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.

Quitline (QL) + App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Patient-Centered Outcomes Research Institute: collaborator

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Lara Coughlin, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Erin Bonar, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lavigne, BA

CONTACT

734-787-2059; lavignem@med.umich.edu

Simran Dhaliwal, BS

CONTACT

734-395-0040; simrand@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF