Exploring the effects of heavy alcohol use on oral health and saliva

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the relationship between alcohol use disorder (AUD) and oral health by evaluating how oral health behaviors impact inflammation in individuals with AUD. It consists of two parts: the first part involves cognitive interviews to assess a new questionnaire on oral health behaviors, while the second part focuses on collecting biological data, including saliva and blood samples, to measure inflammation and stress biomarkers. The study seeks to produce preliminary data on the associations between oral health, salivary biomarkers, and clinical characteristics in AUD patients compared to healthy controls.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Katherine A Maki, C.R.N.P. — National Institutes of Health Clinical Center (CC)
• Study coordinator: Chantal M Gerrard
• Email: chantal.gerrard@nih.gov
• Phone: (202) 839-7356

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.