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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Nicotine Metabolite Ratio

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Georgia Michlig, PhD; Phone Number: 907-729-5421; Email: gmichlig@SouthcentralFoundation.com

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Recruiting
      • Anchorage Native Primary Care Center
      • Contact: Georgia Michlig, PhD; Phone Number: 907-729-5421; Email: gmichlig@SouthcentralFoundation.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

(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)

- 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:

(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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation: Self-report	self-report of cigarette smoking for the past 7 days	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)	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)	Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks

Collaborators and Investigators

• Sponsor: Southcentral Foundation
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Georgia J Michlig, PhD, Southcentral Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1958237; S06GM142122 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No