Recruiting

Metabolism-Informed Care

Sponsor:

Southcentral Foundation

Code:

NCT06556238

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nicotine Metabolite Ratio

Study Details

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

Study ID

NCT06556238

Start date

Nov 17, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 ]
  • Feasibility of intervention implementation: Treatment recommendations [ Time Frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks ]
  • 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 ]
  • Acceptability of metabolism-informed intervention: Quantitative [ Time Frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks ]
  • Acceptability of metabolism-informed intervention: Qualitative [ Time Frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks ]

Central Contacts and Locations

Central contacts

Georgia Michlig, PhD

907-729-5421gmichlig@SouthcentralFoundation.com

Locations

Anchorage Native Primary Care Center

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Georgia Michlig, PhD

907-729-5421gmichlig@SouthcentralFoundation.com

More Information

Sponsor

Southcentral Foundation

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Southcentral Foundation on 2026-04-24.