Rural Smoking Cessation

July 24, 2026 updated by: Masonic Cancer Center, University of Minnesota

Evaluating Population-Based Strategies for Rural Smoking Cessation

Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a SMART, where eligible rural people who smoke (RPWS) can be randomized up to two times to different resources/ways to help quit smoking. For each randomization, participants will use the assigned resources for 3 months, and partake in surveys at baseline, 1, and 3 months, during which they will be asked several questions related to use of resources, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 3 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/) to determine biochemically confirmed abstinence.

Study Type

Interventional

Enrollment (Estimated)

544

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • Masonic Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥ 21 years
  • smoke ≥ 5 cigarettes per day
  • daily access to their own iPhone/Android smartphone or tablet

Exclusion Criteria:

  • past 30-day NRT use or contraindications listed on the NRT labels
  • currently pregnant/breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Condition
Weekly text and email messages referring to Smokefree.gov, NRT Starter kit, free 2-week supply of patches (Nicoderm CQ in either 21 or 14 mg nicotine) and lozenges (Nicorette Nicotine Lozenges, Mint Flavor in either 4 or 2 mg nicotine) with NRT education plus referral to where to request more NRT.
Drug: Nicoderm CQ nicotine patch
Two week supply provided to participants on study.
Drug: Nicorette Nicotine Lozenges
Two week supply provided to participants on study.
No Intervention: Control Condition
Weekly text and email messages referring to Smokefree.gov
No Intervention: RHE - Intervention Condition
Weekly text and email messages on reduced harm or exposure (RHE) tobacco products.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants abstinent from all combustible tobacco products
Time Frame: 3 months
Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cigarettes per day (CPD)
Time Frame: 1 and 3 months
Number of cigarettes smoked per day.
1 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 24, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024LS139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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