Smoking CessationNCT06544811
American Indian Smokefree Native RCT
A study testing Smoking Cessation Program and Cultural Smoking Cessation Program in people with Smoking Cessation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Smoking Cessation Program and Cultural Smoking Cessation Program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 1 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- AI race based on self-report;
- ≥ 18 years of age via photo ID confirmation;
- Average smoked cigarettes per day, ≥ 3 in the past 30 days;
- considering or willing to make a quit attempt;
- self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
- able to read and speak English.
Who cannot join
- None
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
About this study
Official title: Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
Read the detailed description
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
- Conditions
- Smoking Cessation
- Being tested
- Smoking Cessation Program, Cultural Smoking Cessation Program
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation ProgramOther
A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking.
Cultural Smoking Cessation ProgramOther
A free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons.
| Study group | Role | What they receive |
|---|---|---|
| Tailored | Active comparator | Tailored texting program for quit smoking Receives: Other: Cultural Smoking Cessation Program |
| Standard | Placebo comparator | Standard texting program for quit smoking Receives: Other: Smoking Cessation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days [not even a puff of cigarettes, cigars, hookah, or pipe tobacco] with a negative breath CO test ≤ 4 ppm).
Measured: 6 months
Secondary outcomes (10)
Percent of participants that are biochemically-confirmed 7-day abstinence
Percent of participants that are biochemically-confirmed 7-day abstinence at 1, 3 months
Measured: 1 and 3 months
Percent of participants that self-report 24-hour abstinence
Percent of participants that self-report 24-hour abstinence at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Percent of participants that self-report 7-day abstinence
Percent of participants that self-report 7-day abstinence at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Percent of participants that self-report 30-day abstinence
Percent of participants that self-report 30-day abstinence at 3 and 6 months
Measured: 3 and 6 months
Mean cigarettes per day in past 7 days
Change in mean cigarettes per day in past 7 days at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Number of 24-hour quit attempts in past 30 days
Number of 24-hour quit attempts in past 30 days at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Percent of participants that used nicotine replacement therapy and pharmacotherapy
Percent of participants that used nicotine replacement therapy and pharmacotherapy (e.g.
nicotine patch, Chantix) in past 30 days at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Percent of participants that used other behavioral support
Percent of participants that used other behavioral support (e.g. in-person, quitline) for smoking cessation in past 30 days at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Percent of participants that used other commercial tobacco products
Percent of participants that used other commercial tobacco products (e.g., smokeless tobacco, e-cigarettes) in the past 7 days 1, 3, and 6 months
Measured: 1, 3, and 6 months
Mean cigarette dependence
mean cigarette dependence at 1, 3, and 6 months
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start14 Apr 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Oct 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
- Model description
- Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544811
- Sponsor's protocol ID
- 2024LS126
- Status last verified
- Jul 2026
- First submitted
- 5 Aug 2024
- Last updated
- 8 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of A Culturally Aligned Digital Smoking Cessation Resource for American Indian Persons
- ClinicalTrials.gov ID
- NCT06544811
- Acronym / sponsor ID
- 2024LS126
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 9 Aug 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.
The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.
Detailed description
This is a two-arm, parallel group, randomized controlled clinical trial. Eligible participants (n=416) will be randomized to either the culturally aligned resource or the general audience version. Participants will use the assigned resource for 6 months, and partake in surveys at baseline, and 1, 3 and 6 months, during which they will be asked several questions related to use of their assigned resource, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 1, 3 and 6 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-condition, parallel group, RCT design, will examine the efficacy of a culturally aligned digital quit resource versus a general audience version of the resource. This is a multi-site study that will involve participants engaging with their assigned quit resource, and following up with them during months 1, 3 and 6.
| Arm | Type | Receives |
|---|---|---|
| Tailored | Active comparator | Other: Cultural Smoking Cessation ProgramTailored texting program for quit smoking |
| Standard | Placebo comparator | Other: Smoking Cessation ProgramStandard texting program for quit smoking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- AI race based on self-report;
- ≥ 18 years of age via photo ID confirmation;
- Average smoked cigarettes per day, ≥ 3 in the past 30 days;
- considering or willing to make a quit attempt;
- self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Smoking Cessation ProgramA free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking. | Other | Standard |
| Cultural Smoking Cessation ProgramA free text message smoking cessation program that provides 24/7 encouragement, advice, and tips to those trying to quit smoking and has been developed for American Indian and Alaska Native persons. | Other | Tailored |
Primary outcome
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test
Time frame: 6 months
Percent of participants that are biochemically confirmed 7-day abstinence from all combustible tobacco products (defined as self-reported abstinence during the past seven days [not even a puff of cigarettes, cigars, hookah, or pipe tobacco] with a negative breath CO test ≤ 4 ppm).
10 secondary outcomes
Percent of participants that are biochemically-confirmed 7-day abstinence
Time frame: 1 and 3 months
Percent of participants that self-report 24-hour abstinence
Time frame: 1, 3, and 6 months
Percent of participants that self-report 7-day abstinence
Time frame: 1, 3, and 6 months
Percent of participants that self-report 30-day abstinence
Time frame: 3 and 6 months
Mean cigarettes per day in past 7 days
Time frame: 1, 3, and 6 months
Number of 24-hour quit attempts in past 30 days
Time frame: 1, 3, and 6 months
Percent of participants that used nicotine replacement therapy and pharmacotherapy
Time frame: 1, 3, and 6 months
Percent of participants that used other behavioral support
Time frame: 1, 3, and 6 months
Percent of participants that used other commercial tobacco products
Time frame: 1, 3, and 6 months
Mean cigarette dependence
Time frame: 1, 3, and 6 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 8 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 Smoking Cessation Program and Cultural Smoking Cessation Program 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 6 inclusion and 1 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 8 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. Some participants in this study may receive a placebo. 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 (612-624-0132, dcarroll@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants that are biochemically confirmed 7-day abstinence from from all combustible tobacco products with a negative breath CO test (time frame: 6 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 8 Jul 2026.