Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)

NCT06556238 | Recruiting

• 2 other identifiers: 1958237S06GM142122
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. This is a single-arm pilot trial to assess and improve acceptability and feasibility.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (5)

• Feasibility of intervention implementation: Enrollment

  Proportion of eligible persons who enroll

  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

  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.

  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.

  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.

  Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

Secondary Outcomes (3)

• Smoking Cessation: Self-report

  Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

• Smoking Cessation: Expelled CO

  Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

• Smoking Cessation: Nicotine <10ng/mL

  Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

Study Arms (1)

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.

Other: Nicotine Metabolite Ratio

Interventions

Nicotine Metabolite Ratio OTHER

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.

Nicotine Metabolite Ratio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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
• 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)

You may not qualify if:

• (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

Sponsors & Collaborators

• Southcentral Foundation: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Anchorage Native Primary Care Center

Anchorage, Alaska, 99508, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Georgia J Michlig, PhD

  Southcentral Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgia Michlig, PhD

CONTACT

907-729-5421; gmichlig@SouthcentralFoundation.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 15, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)