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Rural Smoking Cessation

NCT ID: NCT06584929

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2029-08-31

Brief Summary

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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

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Nicoderm CQ nicotine patch

Intervention Type DRUG

Two week supply provided to participants on study.

Nicorette Nicotine Lozenges

Intervention Type DRUG

Two week supply provided to participants on study.

Control Condition

Weekly text and email messages referring to Smokefree.gov

Group Type NO_INTERVENTION

No interventions assigned to this group

RHE - Intervention Condition

Weekly text and email messages on reduced harm or exposure (RHE) tobacco products.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nicoderm CQ nicotine patch

Two week supply provided to participants on study.

Intervention Type DRUG

Nicorette Nicotine Lozenges

Two week supply provided to participants on study.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dana Carroll, PhD

Role: CONTACT

[email protected]
612-624-4511

Other Identifiers

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2024LS139

Identifier Type: -

Identifier Source: org_study_id