Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)
NCT Number: NCT06556238
Acronym: QUIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Smoking Cessation
Interventions: OTHER: Nicotine Metabolite Ratio
Sponsor: Southcentral Foundation
Collaborators: National Institute of General Medical Sciences (NIGMS)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-08
Completion Date: 2025-05
Locations: Anchorage Native Primary Care Center, Anchorage, Alaska, 99508, United States

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.

Primary Outcome Measures: 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: 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