[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06556238":3,"trial-entities:NCT06556238":112,"trial-summary:NCT06556238":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":50,"sex":60,"minimum_age":61,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":62,"std_ages":85,"locations":88,"central_contacts":104,"overall_officials":106,"references":110,"see_also_links":111},"NCT06556238","1958237","Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT)","Metabolism-Informed Care to Aid Alaska Native People to Quit Smoking (QUIT): Pilot Intervention and Assessment of Barriers and Facilitators of Implementation","RECRUITING","2026-06","2026-04","2026-04-24","2025-11-17","Southcentral Foundation","OTHER",false,"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.",null,[19],"Smoking Cessation",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},50,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"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\u002Fml 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.",[30],[34,38,41,44,47],{"measure":35,"description":36,"timeFrame":37},"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",{"measure":39,"description":40,"timeFrame":37},"Feasibility of intervention implementation: Treatment recommendations","Proportion who use treatment recommended by NMR results",{"measure":42,"description":43,"timeFrame":37},"Feasibility of intervention implementation: Semi-structured interviews","Qualitatively, based on semi-structured interviews with a selection of participants and care team\u002Fadministrators, thematic analysis will explore barriers and facilitators to using metabolism-informed care, as well as fidelity challenges in adhering to the recommended treatment.",{"measure":45,"description":46,"timeFrame":37},"Acceptability of metabolism-informed intervention: Quantitative","Mean of fourteen, 3-point, Likert-scale survey responses (agree\u002Fneither agree nor disagree\u002Fdisagree, 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.",{"measure":48,"description":49,"timeFrame":37},"Acceptability of metabolism-informed intervention: Qualitative","Additional data will be collected qualitatively via semi-structured interviews with selected participants and care team\u002Fadministrators.",[51,54,57],{"measure":52,"description":53,"timeFrame":37},"Smoking Cessation: Self-report","self-report of cigarette smoking for the past 7 days",{"measure":55,"description":56,"timeFrame":37},"Smoking Cessation: Expelled CO","expelled CO\\\u003C4ppm according to a handheld breath monitor which connects to a mobile device (iCO Smokerlyzer®, Bedfont Scientific)",{"measure":58,"description":59,"timeFrame":37},"Smoking Cessation: Nicotine \u003C10ng\u002FmL","nicotine \\\u003C10ng\u002FmL measured by a saliva test strip (Accutest® NicAlert Saliva Collection Kit)","ALL","18 Years",{"inclusion":63,"exclusion":77,"raw_text":84},[64,65,66,67,68,69,70,71,72,73,74,75,76],"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",[78,79,80,81,82,83],"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","Inclusion Criteria:\n\n(Patients)\n\n* Alaska Native or American Indian person by self-report\n* eligible for or already receiving services at Southcentral Foundation (SCF)\n* age 18 years or older\n* daily smoking in the past 30-days\n* if other nicotine or tobacco products are used, cigarettes are main product used\n* planning to schedule an appointment with the Quit Tobacco Program to seek smoking cessation treatment in the next 30 days\n* willing to make a quit attempt within 30 days of enrollment in the Quit Tobacco Program\n* willing to have a blood test to inform their treatment\n* willing to try a pharmacologic treatment\n* willing to provide a saliva sample\n* has phone service\n* has access to broadband internet on mobile phone at home, work, or other location\n* has an Android or iPhone mobile phone compatible with the Smokerlyzer app\n\n(Staff)\n\n\\- 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\u002Fhealth educators, pharmacists, nurse case managers, behavioral health consultants, certified medical assistants, and lab technicians.\n\nExclusion Criteria:\n\n(Patients)\n\n* Participated in the prior study phase\n* participated in a cessation program during the past 3 months\n* their provider has not approved varenicline in their referral to the Quit Tobacco Program\n* has history of serious hypersensitivity or skin reactions to varenicline\n* has bleeding disorder or is currently receiving cancer treatment\n* questionable capacity or impaired decision-making capacity",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"Anchorage Native Primary Care Center","Anchorage","Alaska","99508","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Georgia Michlig, PhD","CONTACT","907-729-5421","gmichlig@SouthcentralFoundation.com",{"lat":102,"lon":103},61.21806,-149.90028,[105],{"name":97,"role":98,"phone":99,"email":100},[107],{"name":108,"affiliation":13,"role":109},"Georgia J Michlig, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":114},[19],[115],"Nicotine Metabolite Ratio Measurement",{"nct_id":4,"found":117,"summary":118,"prompt_version":127},true,{"design":119,"status":120,"heading":6,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is a single-arm pilot study, meaning all participants will receive the same intervention. It plans to enroll 50 participants.","completed","This study is looking at a new way to help Alaska Native and American Indian people quit smoking. It uses a test called the Nicotine Metabolite Ratio (NMR) to help doctors choose the best medicine to help you stop smoking. The study will involve taking blood samples to measure your NMR. We want to see if this approach is practical and helpful in increasing the number of people who successfully quit smoking. You may be able to join if you are an Alaska Native or American Indian person, are 18 or older, smoke daily, and plan to get help quitting through the Southcentral Foundation Quit Tobacco Program. This study aims to enroll 50 participants.","Participants will be followed for 26 weeks after starting the intervention.",114,"You would have blood drawn by clinical staff. Your participation would involve assessments at 6, 12, and 26 weeks.","Not stated in the trial record.",[30],"v2"]