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| ID | Type | Description | Link |
|---|---|---|---|
| S06GM142122 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Metabolite Ratio | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
(Patients)
(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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgia Michlig, PhD | Contact | 907-729-5421 | gmichlig@SouthcentralFoundation.com |
| Name | Affiliation | Role |
|---|---|---|
| Georgia J Michlig, PhD | Southcentral Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anchorage Native Primary Care Center | Recruiting | Anchorage | Alaska | 99508 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| 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 |