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

Southcentral Foundation

Status: Enrolling

Conditions: Smoking Cessation

Treatments: Other: Nicotine Metabolite Ratio

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06556238

S06GM142122 (U.S. NIH Grant/Contract)

1958237

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nicotine Metabolite Ratio

Experimental group

Description:

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.

Treatment:

Other: Nicotine Metabolite Ratio