[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06684483":3,"trial-entities:NCT06684483":130,"trial-summary:NCT06684483":135},{"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":21,"study_type":29,"primary_purpose":15,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":35,"secondary_outcomes":47,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":79,"locations":82,"central_contacts":99,"overall_officials":108,"references":111,"see_also_links":126},"NCT06684483","10002005","The Impact of Heavy Alcohol Use on Saliva and Oral Health","Quantifying Associations of Stress and Inflammation-Associated Oral Biomarkers With Oral Health, Oral Health Behaviors, Systemic Biomarkers and Clinical Phenotype in Individuals With Alcohol Use Disorder (AUD)","RECRUITING","2026-12-31","2026-08-21","2026-08-28","2025-01-09","National Institutes of Health Clinical Center (CC)","NIH",null,"Background:\n\nPeople with alcohol use disorder (AUD) have a higher rate of dental and gum disease. Poor oral health can increase the risk of other diseases, such as diabetes and stroke. Researchers want to learn more about how to identify developing inflammation in the mouth. They also want to know how improved oral health education and behaviors can affect inflammation in people with AUD.\n\nObjective:\n\nThis study has 2 goals: (1) to test the usefulness of a new questionnaire about oral health and (2) to learn more about how oral health behaviors affect inflammation in people with AUD.\n\nEligibility:\n\nPeople aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed.\n\nDesign:\n\nThe study is divided into 2 parts: People will participate in either one part or the other.\n\nIn part 1, participants will have 1 visit. They will have a physical exam. They will answer 18 questions for a survey about how they care for their teeth.\n\nIn part 2, participants with AUD will have a physical exam. They will provide saliva and blood samples. They will have a dental exam with X-rays. They will fill out questionnaires about their health, mental health, social habits, diet, and sleep. They will keep a diary of their nicotine use for 4 weeks while inpatient.\n\nHealthy volunteers will have 1 visit. They will have a physical exam and provide blood and saliva samples. They will have a dental exam with X-rays. They will fill out questionnaires.","Study Description:\n\nThis is an observational pilot protocol aimed at exploring relationships between clinical phenotype, subjective oral health behaviors, objective oral health, salivary\u002Foral biomarkers, and blood biomarkers in treatment-seeking individuals with alcohol use disorder (AUD). This study has two parts: Part 1 will consist of cognitive interviews to evaluate the content validity and interpretability of the Oral Health Behaviors Assessment Questionnaire (OHBA). Part 2 will include collecting biological and behavioral data including saliva samples, oral mouthwash samples, blood samples, dental exams, and health behavior and symptom data using instruments including the OHBA. The aims of Part 2 are to evaluate the feasibility of salivary biospecimen collection in the quantification of oral and systemic stress and inflammation-associated biomarkers in patients with AUD, and to produce preliminary data for associations of specific oral biomarkers with objective oral health, oral health behaviors, systemic biomarkers, and clinical phenotype in patients with AUD compared to controls matched on age, sex, and smoking status.\n\nObjectives:\n\nPart 1\n\nPrimary Objective:\n\nTo evaluate the interpretability and construct validity of the OHBA by conducting cognitive interviews in both treatment-seeking participants with AUD and healthy control participants.\n\nPart 2\n\nPrimary Objectives:\n\n* To evaluate study procedures in using saliva samples to measure inflammation and stress-associated biomarkers in participants with AUD and controls.\n* To examine relationships between oral health behaviors, oral health, clinical symptoms, salivary characteristics, salivary biomarkers, and blood biomarkers in patients with AUD and controls.\n\nSecondary Objectives:\n\n* To assess the impact of heavy alcohol consumption on salivary characteristics and salivary biomarkers in treatment-seeking patients with AUD at inpatient admission versus controls.\n* To evaluate if oral health, salivary characteristics, and salivary biomarkers change as patients undergo inpatient treatment for AUD.\n\nTo determine if associations between oral health, salivary characteristics, salivary biomarker levels, blood biomarker levels, and clinical symptoms differ after a period of abstinence from alcohol as patients undergo inpatient treatment for AUD (i.e., within-group comparison of admission visit versus dental exam visit).\n\nTertiary\u002FExploratory Objectives:\n\n* To explore correlations and measure differences between oral microbiome-associated biomarkers and oral health, salivary characteristics, salivary biomarker levels, blood biomarker levels, and clinical symptoms in patients with AUD and controls.\n* To determine if associations between oral microbiome characteristics and oral health, salivary characteristics, salivary biomarker levels, blood biomarker levels, and clinical symptoms differ after a period of abstinence from alcohol as patients undergo inpatient treatment for AUD.\n\nEndpoints:\n\nPart 1\n\nPrimary Endpoint:\n\nCompletion of cognitive interviewing, research team meeting to discuss results and editing of any language in the OHBA (if applicable) based on the cognitive interviewing results used to improve subject understanding and acceptability of the questions in the instrument. Submission of OHBA revisions to IRB will be made if edits to the instrument are made.\n\nPart 2\n\nPrimary Endpoints:\n\n* Feasibility (sample processing, saliva characterization, analyte measurement and analysis considerations) of saliva biomarker quantification measured after two visits in patients with AUD (admission visit, dental exam visit) and one visit in controls (dental exam visit).\n* Quantification of oral health behaviors, oral health, clinical symptoms, salivary characteristics (salivary flow rate, salivary pH) and salivary and blood biomarker levels in patients with AUD and controls at dental exam visit.\n\nSecondary Endpoints:\n\n* Quantification of oral health (Modified Beck's Oral Assessment Scale \\[Modified BOAS\\], dental exam assessment metrics), clinical symptoms (perceived stress, anxiety, depression, and sleep disturbance), salivary characteristics (salivary flow rate, salivary pH) in patients with AUD at inpatient admission visit and controls at dental exam visit.\n* Changes in oral health, salivary characteristics, and salivary biomarker levels in patients with AUD from admission visit to dental exam visit.\n* Changes in relationships between oral health, salivary characteristics, and salivary biomarker levels with blood biomarker levels, and clinical symptoms in patients with AUD from admission visit to dental exam visit.\n\nTertiary\u002FExploratory Endpoints:\n\n* Quantification of oral microbiome community characteristics in patients with AUD and controls at dental exam visit. Measurement of relationships between oral microbiome characteristics with oral health behaviors, oral health, clinical symptoms, salivary characteristics, and salivary and blood biomarker levels in patients with AUD and controls at dental exam visit.\n* Differences in oral microbiome community characteristics in patients with AUD from admission visit to dental exam visit. Changes in relationships between oral microbiome community characteristics with oral health, salivary characteristics, and salivary biomarker levels with blood biomarker levels, and clinical symptoms in patients with AUD from admission visit to dental exam visit.",[19,20],"Alcohol Use Disorder","Alcohol Dependence",[22,19,23,24,25,26,27,28],"Oral Health Behaviors","Salivary Bioscience","Stress","Health Behaviors","Salivary Biomarker","Inflammation","Neuropsychological Symptoms","OBSERVATIONAL",[],{"count":32,"type":33},72,"ESTIMATED",[],[36,40,44],{"measure":37,"description":38,"timeFrame":39},"Completion of a total of 12 cognitive interviews in participants with AUD (n=6) & healthy participants (n=6). Editing of any language in the OHBA (if applicable) as a result of the cognitive interviewing results.","The endpoint will refine the OHBA questionnaire, if needed, to improve subject understanding and acceptability of the questions in the instrument; a primary measure in the Part 2 portion of the current study.","Until endpoint is reached.",{"measure":41,"description":42,"timeFrame":43},"Feasibility of saliva biomarker quantification measured after 2 visits in patients with AUD and one dental visit in controls.","This endpoint will identify if salivary samples are appropriate to measure inflammation and stress-associated biomarkers in patients with AUD, if special procedures need to be performed to quantify salivary biomarkers in patients with AUD and the identification of other variables that may influence salivary samples in patients with AUD for future research consideration.","When recruitment and sample processing is complete.",{"measure":45,"description":46,"timeFrame":43},"Quantification of oral health behaviors, oral health, clinical symptoms, salivary characteristics, and salivary and blood biomarker levels in patients with AUD and controls at dental exam visit.","The endpoints will be measured to evaluate relationships between potential salivary signaling biomarkers and multiple facets of oral and systemic health and health behaviors.",[48,51,54],{"measure":49,"description":50,"timeFrame":43},"Quantification of oral health, clinical symptoms, salivary characteristics in patients with AUD at inpatient admission visit and controls at dental exam visit.","Comparison of saliva characteristics and associated biomarkers shortly after a period of heavy alcohol use in patients with AUD compared to controls.",{"measure":52,"description":53,"timeFrame":43},"Changes in oral health, salivary characteristics, and salivary biomarker levels in patients with AUD from admission visit to dental exam visit","This will allow evaluation if saliva characteristics and associated biomarkers change during a period of abstinence from alcohol after heavy use in patients with AUD.",{"measure":55,"description":56,"timeFrame":43},"Changes in relationships between oral health, salivary characteristics, and salivary biomarker levels with blood biomarker levels, and clinical symptoms in patients with AUD from admission visit to dental exam visit.","Assessment if there is a difference in associations between oral health and salivary characteristics with blood biomarker levels and clinical symptoms when evaluated in the context of heavy alcohol use compared to a period of sobriety in the same population during inpatient treatment for AUD.","ALL","18 Years","100 Years",true,{"inclusion":62,"exclusion":72,"raw_text":78},[63,64,65,66,67,68,63,69,65,70,67,68,71],"Stated willingness to comply with all study procedures and availability for the duration of the study.","Treatment-seeking individuals aged 18 years or older.","Able to read and speak English.","Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.","Part 1 Only: Agree for audio recording of cognitive interview.","Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.","Individuals aged 18 years or older.","Self-reported to be in good physical health.","AUDIT score of 7 or below.",[73,74,75,76,77],"The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).","Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).","Pregnant or breastfeeding","Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.","Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.","* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\nAUD participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Treatment-seeking individuals aged 18 years or older.\n* Able to read and speak English.\n* Admitted and consented for 14-AA-0181 at the NIH CC for inpatient treatment.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n\nHealthy Control Participants:\n\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Individuals aged 18 years or older.\n* Able to read and speak English.\n* Self-reported to be in good physical health.\n* Part 1 Only: Agree for audio recording of cognitive interview.\n* Part 2 Only: BMI less than or equal to 30 kg\u002Fm\\^2.\n* AUDIT score of 7 or below.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nPatients with AUD and Healthy Control Participants:\n\n* The presence of a condition or illness that would hamper the individual giving informed consent (e.g., cognitive impairment).\n* Part 2 Only: Self-reported presence of a condition or illness that would prevent the individual to have a diagnostic oral examination (e.g., oral cancer of the mouth, Sjogren's syndrome).\n* Part 2 Only: Currently taking or have taken any of the following medications within the last month by self-report; Antibiotics, Corticosteroids, Immunosuppressive or Cytotoxic agents. Topical antibiotics and\u002For corticosteroids on areas other than the oral cavity are not exclusion criteria.\n* Pregnant or breastfeeding\n* Subjects who participate in Part 1 of the protocol will not be eligible for Part 2.\n* Non-English speakers: we do not have a Spanish version of OHBA, and we are exploring cognitive interviewing of the instrument in English currently. Also, the pt's on 1SE (half of the focused population for this study) are not typically Spanish speakers. We also do not have many of the surveys we plan to administer in Spanish, and they may not be available in other languages.",[80,81],"ADULT","OLDER_ADULT",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":96},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States",[90],{"name":91,"role":92,"phone":93,"phoneExt":94,"email":95},"NIH Clinical Center Office of Patient Recruitment (OPR)","CONTACT","800-411-1222","TTY dial 711","ccopr@nih.gov",{"lat":97,"lon":98},38.98067,-77.10026,[100,104],{"name":101,"role":92,"phone":102,"email":103},"Chantal M Gerrard","(202) 839-7356","chantal.gerrard@nih.gov",{"name":105,"role":92,"phone":106,"email":107},"Katherine A Maki, C.R.N.P.","(301) 451-8338","katherine.maki@nih.gov",[109],{"name":105,"affiliation":13,"role":110},"PRINCIPAL_INVESTIGATOR",[112,116,119,122],{"pmid":113,"type":114,"citation":115},"36503487","BACKGROUND","Maki KA, Ganesan SM, Meeks B, Farmer N, Kazmi N, Barb JJ, Joseph PV, Wallen GR. The role of the oral microbiome in smoking-related cardiovascular risk: a review of the literature exploring mechanisms and pathways. J Transl Med. 2022 Dec 12;20(1):584. doi: 10.1186\u002Fs12967-022-03785-x.",{"pmid":117,"type":114,"citation":118},"34880965","Barb JJ, Maki KA, Kazmi N, Meeks BK, Krumlauf M, Tuason RT, Brooks AT, Ames NJ, Goldman D, Wallen GR. The oral microbiome in alcohol use disorder: a longitudinal analysis during inpatient treatment. J Oral Microbiol. 2021 Dec 1;14(1):2004790. doi: 10.1080\u002F20002297.2021.2004790. eCollection 2022.",{"pmid":120,"type":114,"citation":121},"38514150","Maki KA, Crayton CB, Butera G, Wallen GR. Examining the relationship between the oral microbiome, alcohol intake and alcohol-comorbid neuropsychological disorders: protocol for a scoping review. BMJ Open. 2024 Mar 21;14(3):e079823. doi: 10.1136\u002Fbmjopen-2023-079823.",{"pmid":123,"type":124,"citation":125},"41407429","DERIVED","Maki KA, Xu S, Wallen GR, Gerrard C, Sung C, Papneja S, Tuason RTS, Ramchandani VA, Diazgranados N, Barb JJ. Associations between oral health behaviours, oral health, salivary biomarkers and clinical phenotype in individuals with alcohol use disorder: protocol for a longitudinal observational study. BMJ Open. 2025 Dec 17;15(12):e101197. doi: 10.1136\u002Fbmjopen-2025-101197.",[127],{"label":128,"url":129},"NIH Clinical Center Detailed Web Page","https:\u002F\u002Fclinicalstudies.info.nih.gov\u002Fcgi\u002Fdetail.cgi?A_002005-CC.html",{"nct_id":4,"conditions":131,"biomarkers":134},[132,133],"Alcohol use disorder","Health, Oral",[],{"nct_id":4,"found":60,"summary":136,"prompt_version":146},{"design":137,"status":138,"heading":139,"summary":140,"follow_up":141,"word_count":142,"commitments":143,"compensation":144,"drugs_mentioned":145},"This is an observational study involving 72 participants. It is designed to explore the links between oral health, behaviors, and biological markers in people with alcohol use disorder and healthy individuals.","completed","Observational Study on Alcohol Use and Oral Health","This observational study is looking at how heavy alcohol use affects your mouth and overall health. People with alcohol use disorder (AUD) often have more dental and gum problems, which can lead to other health issues like diabetes or stroke. Researchers want to understand how to spot early signs of inflammation in the mouth and how better oral hygiene can help people with AUD. The study has two main goals: to test a new questionnaire about oral health behaviors and to learn more about how these behaviors impact inflammation in people with AUD. You can join if you are 18 or older, are being treated for AUD, and can speak English. Healthy volunteers are also needed. The study is currently recruiting 72 participants.","The study measures outcomes when recruitment and sample processing are complete, and until the primary endpoint of cognitive interviews is reached.",123,"You will have at least two visits if you have AUD, or one dental visit if you are a control. These visits will involve collecting saliva, mouthwash, and blood samples, as well as dental exams and filling out questionnaires.","Not stated in the trial record.",[],"v2"]