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Recruiting NCT06556238

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

No phase Interventional Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nicotine Metabolite Ratio.
Who it may be relevant to
Registry conditions: Smoking Cessation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 med

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Smoking Cessation: Self-report [Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Smoking Cessation: Expelled CO [Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]
  • Smoking Cessation: Nicotine <10ng/mL [Time frame: Beta phase (n=10) 6 weeks; Pilot phase (n=40) 6 weeks, 12 weeks, 26 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Anchorage Native Primary Care Center — Anchorage

Identifiers

NCT: NCT06556238 · 1958237 · S06GM142122

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗