Smoking CessationQUITNCT06556238
Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)
A study testing Nicotine Metabolite Ratio in people with Smoking Cessation, run by Southcentral Foundation at 1 site in United States.
Trial summary
The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Nicotine Metabolite Ratio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Jun 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (Patients)
- Alaska Native or American Indian person by self-report
- eligible for or already receiving services at Southcentral Foundation (SCF)
- age 18 years or older
- daily smoking in the past 30-days
- if other nicotine or tobacco products are used, cigarettes are main product used
Show all 16Show fewer
- planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days
- willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program
- willing to have a blood test to inform their treatment
- willing to try a pharmacologic treatment
- willing to provide a saliva sample
- has phone service
- has access to broadband internet on mobile phone at home, work, or other location
- has an Android or iPhone mobile phone compatible with the Smokerlyzer app
- (Staff)
- Staff participants of qualitative interviews to assess acceptability and feasibility of the intervention must be a health care professional at Southcentral Foundation (SCF), involved in the care of one of the participants of the study, that is their care team staff; including but not limited to: primary care providers, tobacco treatment specialists/health educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.
Who cannot join
- (Patients)
- Participated in the prior study phase
- participated in a cessation program during the past 3 months
- their provider has not approved varenicline in their referral to the Quit Tobacco Program
- has history of serious hypersensitivity or skin reactions to varenicline
- has bleeding disorder or is currently receiving cancer treatment
- questionable capacity or impaired decision-making capacity
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
Anchorage Native Primary Care Center
Anchorage, Alaska, 99508
Georgia Michlig, PhD, 907-729-5421, gmichlig@SouthcentralFoundation.com
About this study
Official title: Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation
The purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.
- Conditions
- Smoking Cessation
- Being tested
- Nicotine Metabolite Ratio
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Metabolite RatioOther
Blood specimens will be drawn, in clinic, by clinical staff trained in blood collection (e.g., certified medical assistant, nurse). Through regular clinic procedures, lab staff will ship for processing to Quest. Quest uses liquid chromatography tandem mass spectrometry with a limit of detection of 2ng/ml for all analytes and will quantify NMR within 3-6 days of sample arrival. Samples will be consumed during testing. Results of NMR will be returned to primary care providers, and NMR-informed medication recommendations will be made to participants.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Metabolite Ratio | Experimental | Subjects identified as cigarette smokers wishing to quit will receive the Nicotine Metabolite Ratio (NMR) test in a primary care setting and the results of the NMR will be used to inform medication recommendations for tobacco cessation. Receives: Other: Nicotine Metabolite Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention implementation: Enrollment
Proportion of eligible persons who enroll
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Feasibility of intervention implementation: Treatment recommendations
Proportion who use treatment recommended by NMR results
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Feasibility of intervention implementation: Semi-structured interviews
Qualitatively, based on semi-structured interviews with a selection of participants and care team/administrators, thematic analysis will explore barriers and facilitators to using metabolism-informed care, as well as fidelity challenges in adhering to the recommended treatment.
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Acceptability of metabolism-informed intervention: Quantitative
Mean of fourteen, 3-point, Likert-scale survey responses (agree/neither agree nor disagree/disagree, with a "prefer not to answer" option). These items will assess intervention and process acceptability including timeliness of the procedures and recommendation, composition of the team, clarity of communication, ease of understanding pilot measures, willingness to recommend, and satisfaction. These items will be combined into a summary score indicating overall acceptability of the intervention.
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Acceptability of metabolism-informed intervention: Qualitative
Additional data will be collected qualitatively via semi-structured interviews with selected participants and care team/administrators.
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Secondary outcomes (3)
Smoking Cessation: Self-report
self-report of cigarette smoking for the past 7 days
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Smoking Cessation: Expelled CO
expelled CO<4ppm according to a handheld breath monitor which connects to a mobile device (iCO Smokerlyzer®, Bedfont Scientific)
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Smoking Cessation: Nicotine <10ng/mL
nicotine <10ng/mL measured by a saliva test strip (Accutest® NicAlert Saliva Collection Kit)
Measured: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start17 Nov 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southcentral Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Georgia Michlig, Southcentral Foundation
- Investigators
- Georgia J Michlig, PhD, Principal investigator, Southcentral Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556238
- Sponsor's protocol ID
- 1958237
- Other IDs
- S06GM142122
- Acronym
- QUIT
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation
- ClinicalTrials.gov ID
- NCT06556238
- Acronym / sponsor ID
- QUIT / 1958237
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Southcentral FoundationUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 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 purpose of this study is to refine and pilot an intervention using the Nicotine Metabolite Ratio (NMR) to inform the selection of pharmacologic treatment to increase smoking abstinence among Alaska Native and American Indian people. This is a single-arm pilot trial to assess and improve acceptability and feasibility.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Metabolite Ratio | Experimental | Other: Nicotine Metabolite RatioSubjects identified as cigarette smokers wishing to quit will receive the Nicotine Metabolite Ratio (NMR) test in a primary care setting and the results of the NMR will be used to inform medication recommendations for tobacco cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- (Patients)
- Alaska Native or American Indian person by self-report
- eligible for or already receiving services at Southcentral Foundation (SCF)
- age 18 years or older
- daily smoking in the past 30-days
Key exclusion criteria (7 listed)
- (Patients)
- Participated in the prior study phase
- participated in a cessation program during the past 3 months
- their provider has not approved varenicline in their referral to the Quit Tobacco Program
- has history of serious hypersensitivity or skin reactions to varenicline
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 |
|---|---|---|
| Nicotine Metabolite RatioBlood specimens will be drawn, in clinic, by clinical staff trained in blood collection (e.g., certified medical assistant, nurse). Through regular clinic procedures, lab staff will ship for processing to Quest. Quest uses liquid chromatography tandem mass spectrometry with a limit of detection of 2ng/ml for all analytes and will quantify NMR within 3-6 days of sample arrival. Samples will be consumed during testing. Results of NMR will be returned to primary care providers, and NMR-informed medication recommendations will be made to participants. | Other | Nicotine Metabolite Ratio |
Primary outcome
Feasibility of intervention implementation: Enrollment
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Proportion of eligible persons who enroll
Feasibility of intervention implementation: Treatment recommendations
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Proportion who use treatment recommended by NMR results
Feasibility of intervention implementation: Semi-structured interviews
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Qualitatively, based on semi-structured interviews with a selection of participants and care team/administrators, thematic analysis will explore barriers and facilitators to using metabolism-informed care, as well as fidelity challenges in adhering to the recommended treatment.
Acceptability of metabolism-informed intervention: Quantitative
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Mean of fourteen, 3-point, Likert-scale survey responses (agree/neither agree nor disagree/disagree, with a "prefer not to answer" option). These items will assess intervention and process acceptability including timeliness of the procedures and recommendation, composition of the team, clarity of communication, ease of understanding pilot measures, willingness to recommend, and satisfaction. These items will be combined into a summary score indicating overall acceptability of the intervention.
Acceptability of metabolism-informed intervention: Qualitative
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Additional data will be collected qualitatively via semi-structured interviews with selected participants and care team/administrators.
3 secondary outcomes
Smoking Cessation: Self-report
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Smoking Cessation: Expelled CO
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
Smoking Cessation: Nicotine <10ng/mL
Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Georgia J Michlig, PhD principal investigator
Southcentral Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Metabolite Ratio in people with Smoking Cessation, run by Southcentral Foundation 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 16 inclusion and 7 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 24 Apr 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 Georgia Michlig, PhD (907-729-5421, gmichlig@SouthcentralFoundation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention implementation: Enrollment (time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks). The study lists 5 primary outcomes in all. 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 24 Apr 2026.