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Mouth may reveal hidden inflammation in alcohol use disorder

NCT ID NCT06684483

Knowledge-focused Sponsor: National Institutes of Health Clinical Center (CC) Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study looks at how stress and oral health habits relate to inflammation in people with alcohol use disorder (AUD). Researchers will test a new questionnaire about oral care and collect saliva, blood, and dental X-rays from 72 participants (AUD patients and healthy volunteers). The goal is to understand how mouth inflammation connects to overall health, which could lead to better ways to prevent gum disease and other illnesses in people with AUD.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify early signs of mouth inflammation in people with alcohol use disorder, leading to better oral health monitoring and prevention of related diseases.
What could go wrong
This is an early observational study with only 72 participants, so results may not apply to everyone. It aims to gather knowledge, not test a treatment, so no direct health benefits are guaranteed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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.

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Conditions

The condition(s) this trial relates to.

alcohol abuse alcohol dependence Health Behavior Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol dependence Alcohol use disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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