Smoking CessationNCT06584929
Rural Smoking Cessation
A study testing Nicoderm CQ nicotine patch and Nicorette Nicotine Lozenges in people with Smoking Cessation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicoderm CQ nicotine patch and Nicorette Nicotine Lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 21 years
- smoke ≥ 5 cigarettes per day
- daily access to their own iPhone/Android smartphone or tablet
Who cannot join
- past 30-day NRT use or contraindications listed on the NRT labels
- currently pregnant/breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Masonic Cancer Center
Minneapolis, Minnesota, 55455
Dana Carroll, PhD, MPH, 612-624-4610, tobacco@umn.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Nicoderm CQ nicotine patch, Nicorette Nicotine Lozenges
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicoderm CQ nicotine patchDrug
Two week supply provided to participants on study.
Nicorette Nicotine LozengesDrug
Two week supply provided to participants on study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nicoderm CQ nicotine patch; Drug: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants abstinent from all combustible tobacco products
Biochemically-confirmed 7-day abstinence from all combustible tobacco products at 3 months.
Measured: 3 months
Secondary outcomes (1)
Cigarettes per day (CPD)
Number of cigarettes smoked per day.
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start17 Mar 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584929
- Sponsor's protocol ID
- 2024LS139
- Status last verified
- Jul 2026
- First submitted
- 3 Sep 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Population-Based Strategies for Rural Smoking Cessation
- ClinicalTrials.gov ID
- NCT06584929
- Acronym / sponsor ID
- 2024LS139
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Drug: Nicoderm CQ nicotine patch, Drug: Nicorette Nicotine LozengesWeekly 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 21 years
- smoke ≥ 5 cigarettes per day
- daily access to their own iPhone/Android smartphone or tablet
Key exclusion criteria (2 listed)
- past 30-day NRT use or contraindications listed on the NRT labels
- currently pregnant/breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicoderm CQ nicotine patchTwo week supply provided to participants on study. | Drug | Intervention Condition |
| Nicorette Nicotine LozengesTwo week supply provided to participants on study. | Drug | Intervention Condition |
Primary outcome
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.
1 secondary outcome
Cigarettes per day (CPD)
Time frame: 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicoderm CQ nicotine patch and Nicorette Nicotine Lozenges in people with Smoking Cessation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dana Carroll, PhD (612-624-4511, dcarroll@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants abstinent from all combustible tobacco products (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.