Rural Smoking Cessation

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation
• Interventions: Drug: Nicoderm CQ nicotine patch; Drug: Nicorette Nicotine Lozenges

• Registration Number: NCT06584929
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-05
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Study Start: 2025-05-01
• Primary Completion: 2028-10-01
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Condition	Nicorette Nicotine Lozenges	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.
Intervention Condition	Nicoderm CQ nicotine patch	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.

Primary Outcome Measures

Name	Time	Method
Number of participants abstinent from all combustible tobacco products	3 months	Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months.

Secondary Outcome Measures

Name	Time	Method
Cigarettes per day (CPD)	1 and 3 months	Number of cigarettes smoked per day.