Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)
NCT ID: NCT06556238
Last Updated: 2025-11-14
Study Results
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-11-17
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Nicotine Metabolite Ratio
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.
Nicotine Metabolite Ratio
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.
Interventions
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Nicotine Metabolite Ratio
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Southcentral Foundation
OTHER
Responsible Party
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Georgia Michlig
Senior Researcher
Principal Investigators
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Georgia J Michlig, PhD
Role: PRINCIPAL_INVESTIGATOR
Southcentral Foundation
Locations
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Anchorage Native Primary Care Center
Anchorage, Alaska, United States
Countries
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Central Contacts
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Facility Contacts
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Todd Takeno, MA
Role: primary
Other Identifiers
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1958237
Identifier Type: -
Identifier Source: org_study_id