NCT06584929

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
41mo left

Started May 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Aug 2029

First Submitted

Initial submission to the registry

September 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

September 3, 2024

Last Update Submit

March 10, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Number of participants abstinent from all combustible tobacco products

    Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months.

    3 months

Secondary Outcomes (1)

  • Cigarettes per day (CPD)

    1 and 3 months

Study Arms (3)

Intervention Condition

EXPERIMENTAL

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 patchDrug: Nicorette Nicotine Lozenges

Control Condition

NO INTERVENTION

Weekly text and email messages referring to Smokefree.gov

RHE - Intervention Condition

NO INTERVENTION

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

Interventions

Nicoderm CQ nicotine patchDRUG

Two week supply provided to participants on study.

Intervention Condition
Nicorette Nicotine LozengesDRUG

Two week supply provided to participants on study.

Intervention Condition

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Dana Carroll, PhD

CONTACT

612-624-4511dcarroll@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2024

First Posted

September 5, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

August 31, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03