The Impact of Heavy Alcohol Use on Saliva and Oral Health

NCT06684483 | Recruiting

• 2 other identifiers: 10002005002005-CC
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Background: People 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. Objective: This 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. Eligibility: People aged 18 years and older who are staying on an inpatient unit being treated for AUD. Healthy volunteers are also needed. Design: The study is divided into 2 parts: People will participate in either one part or the other. In 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. In 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. Healthy 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.

Conditions

Alcohol Use Disorder; Alcohol Dependence

Keywords

Oral Health Behaviors; Alcohol Use Disorder; Salivary Bioscience; Stress; Health Behaviors; Salivary Biomarker; Inflammation; Neuropsychological Symptoms

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

  When recruitment and sample processing is complete.

Secondary Outcomes (3)

• Quantification of oral health, clinical symptoms, salivary characteristics in patients with AUD at inpatient admission visit and controls at dental exam visit.

  When recruitment and sample processing is complete.

• Changes in oral health, salivary characteristics, and salivary biomarker levels in patients with AUD from admission visit to dental exam visit

  When recruitment and sample processing is complete.

• 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.

  When recruitment and sample processing is complete.

Study Arms (2)

Healthy volunteers

Age, smoking status and gender matched healthy volunteers.

Patients with AUD

Patients with alcohol use disorder seeking inpatient treatment.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Part 1 of the study will recruit adults (\>=18 years) who are enrolled in inpatient treatment for AUD (n=6) and healthy controls (n=6) to conduct cognitive interviews and evaluate the interpretation of the Oral Health Behaviors Assessment measure. Part 2 will recruit adults (\>=18 years) who are enrolled in inpatient treatment for AUD at the NIH Clinical Center (n=30) and healthy controls matched on age, sex, and smoking status (n=30). The total sample size of this study, including both Parts 1 and 2 participants will be n=72.

You may qualify if:

• To be eligible to participate in this study, an individual must meet all the following criteria:
• AUD participants:
• 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/m\^2.
• Healthy Control Participants:
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Individuals aged 18 years or older.
• Able to read and speak English.
• Self-reported to be in good physical health.
• Part 1 Only: Agree for audio recording of cognitive interview.
• Part 2 Only: BMI less than or equal to 30 kg/m\^2.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Patients with AUD and Healthy Control Participants:
• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• 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/s12967-022-03785-x.

  PMID: 36503487 BACKGROUND

• 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: 10.1080/20002297.2021.2004790. eCollection 2022.

  PMID: 34880965 BACKGROUND

• 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/bmjopen-2023-079823.

  PMID: 38514150 BACKGROUND

• 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/bmjopen-2025-101197.

  PMID: 41407429 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Health Behavior; Inflammation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katherine A Maki, C.R.N.P.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal M Gerrard

CONTACT

(202) 839-7356; chantal.gerrard@nih.gov

Katherine A Maki, C.R.N.P.

CONTACT

(301) 451-8338; katherine.maki@nih.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: In line with publication of results.
• Access Criteria: De-identified datasets used to generate results presented in manuscripts will be deposited into a repository that can be publicly accessible in line with NIH regulations. In compliance with ethical standards and institutional policies, other access to individual participant data will be governed by a structured data-sharing framework to ensure participant privacy and confidentiality. Access to IPD will be granted under a Data Use Agreement that specifies permissible uses, prohibits re-identification or further data sharing, and requires secure storage and handling of data. Access will be restricted to de-identified or coded datasets, with direct identifiers removed.

Locations

US (1)