Alcohol Use DisorderNCT06684483
The Impact of Heavy Alcohol Use on Saliva and Oral Health
An observational study of Alcohol Use Disorder and Alcohol Dependence, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Dependence
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: 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)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder, Alcohol Dependence
- Keywords
- Oral Health Behaviors, Alcohol Use Disorder, Salivary Bioscience, Stress, Health Behaviors, Salivary Biomarker, Inflammation, Neuropsychological Symptoms
- Medical subject headings
- Alcoholism, Health Behavior, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Age, smoking status and gender matched healthy volunteers. | |
| Patients with AUD | Patients with alcohol use disorder seeking inpatient treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Comparison of saliva characteristics and associated biomarkers shortly after a period of heavy alcohol use in patients with AUD compared to controls.
Measured: 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
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.
Measured: 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.
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.
Measured: When recruitment and sample processing is complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start9 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine A Maki, C.R.N.P., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684483
- Sponsor's protocol ID
- 10002005
- Other IDs
- 002005-CC
- Status last verified
- 21 Aug 2026
- First submitted
- 9 Nov 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be deposited into a data repository in line with NIH regulations.
Publications
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.
PubMed 36503487Barb 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.
PubMed 34880965Maki 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.
PubMed 38514150Maki 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.
PubMed 41407429
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06684483
- Acronym / sponsor ID
- 10002005
- Conditions
- Alcohol Use Disorder, Alcohol Dependence
- Keywords
- Oral Health Behaviors, Alcohol Use Disorder, Salivary Bioscience, Stress, Health Behaviors, Salivary Biomarker, Inflammation, Neuropsychological Symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | –Age, smoking status and gender matched healthy volunteers. |
| Patients with AUD | – | –Patients with alcohol use disorder seeking inpatient treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- To be eligible to participate in this study, an individual must meet all the following criteria:
- 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.
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Until endpoint is reached.
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.
Feasibility of saliva biomarker quantification measured after 2 visits in patients with AUD and one dental visit in controls.
Time frame: When recruitment and sample processing is complete.
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.
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.
Time frame: When recruitment and sample processing is complete.
The endpoints will be measured to evaluate relationships between potential salivary signaling biomarkers and multiple facets of oral and systemic health and health behaviors.
3 secondary outcomes
Quantification of oral health, clinical symptoms, salivary characteristics in patients with AUD at inpatient admission visit and controls at dental exam visit.
Time frame: 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
Time frame: 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.
Time frame: When recruitment and sample processing is complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Background: PubMed 36503487Maki 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.
- Background: PubMed 34880965Barb 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.
- Background: PubMed 38514150Maki 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.
- Derived from this study: PubMed 41407429Maki 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be deposited into a data repository in line with NIH regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine A Maki, C.R.N.P. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder and Alcohol Dependence, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal M Gerrard ((202) 839-7356, chantal.gerrard@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Until endpoint is reached.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06684483, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.