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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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^
- •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^
- •AUDIT score of 7 or below.
排除标准
- •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
- •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.
研究组 & 干预措施
Healthy volunteers
Age, smoking status and gender matched healthy volunteers.
Patients with AUD
Patients with alcohol use disorder seeking inpatient treatment.
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Quantification of oral health, clinical symptoms, salivary characteristics in patients with AUD at inpatient admission visit and controls at dental exam visit.(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(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.(When recruitment and sample processing is complete.)