Protocol Details

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)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

002005-CC

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 100 Years

Referral Letter Required

No

Population Exclusion(s)

Children;
Pregnant Women;
Non-English Speaking;
Adults who are or may become unable to consent

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Alcohol Use Disorder;
Alcohol Dependence

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

Eligibility

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.


Citations:

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; PMCID: PMC9743777.

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. PMID: 34880965; PMCID: PMC8648028.

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; PMCID: PMC10961520.

Contacts:

Principal Investigator

Referral Contact

For more information:

Katherine A. Maki, C.R.N.P.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2B10
10 CENTER DR
BETHESDA MD 20892
(301) 451-8338
katherine.maki@nih.gov
Chantal M. Gerrard
National Institutes of Health Clinical Center (CC)
BG 10 RM 4C422
10 CENTER DR
BETHESDA MD 20814
(202) 839-7356
chantal.gerrard@nih.gov
Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT06684483
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