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NCT Number: NCT06556238

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anchorage Native Primary Care Center

Anchorage, Alaska, 99508, United States

Location status: Recruiting

Location contact

Georgia Michlig, PhD

CONTACT

[email protected]

907-729-5421

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Smoking Cessation: Self-report

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

    self-report of cigarette smoking for the past 7 days

  2. Smoking Cessation: Expelled CO

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

    expelled CO<4ppm according to a handheld breath monitor which connects to a mobile device (iCO Smokerlyzer®, Bedfont Scientific)

  3. Smoking Cessation: Nicotine <10ng/mL

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

    nicotine <10ng/mL measured by a saliva test strip (Accutest® NicAlert Saliva Collection Kit)

Study contacts

Contact information is provided by the study sponsor or research team.

Georgia Michlig, PhD

CONTACT

[email protected]

907-729-5421

Sponsors and collaborators

Lead sponsor

Southcentral Foundation

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation

Acronym: QUIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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