The Impact of Heavy Alcohol Use on Saliva and Oral Health

Study Description:

This is an observational pilot protocol aimed at exploring relationships between clinical phenotype, subjective oral health behaviors, objective oral health, salivary/oral 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.

Objectives:

Part 1

Primary Objective:

To evaluate the interpretability and construct validity of the OHBA by conducting cognitive interviews in both treatment-seeking participants with AUD and healthy control participants.

Part 2

Primary Objectives:

• To evaluate study procedures in using saliva samples to measure inflammation and stress-associated biomarkers in participants with AUD and controls.
• To examine relationships between oral health behaviors, oral health, clinical symptoms, salivary characteristics, salivary biomarkers, and blood biomarkers in patients with AUD and controls.

Secondary Objectives:

• 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.
• To evaluate if oral health, salivary characteristics, and salivary biomarkers change as patients undergo inpatient treatment for AUD.

To 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).

Tertiary/Exploratory Objectives:

• 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.
• 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.

Endpoints:

Part 1

Primary Endpoint:

Completion 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.

Part 2

Primary Endpoints:

• 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).
• 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.

Secondary Endpoints:

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

Tertiary/Exploratory Endpoints:

• 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.
• 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.

• INCLUSION CRITERIA:

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.
• AUDIT score of 7 or below.

Exclusion criteria

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).
• 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/or corticosteroids on areas other than the oral cavity are not exclusion criteria.
• 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.