Comparative Risk of Oral Complications Associated with Medications for Opioid Use Disorder: A Mixed-Methods Approach

与阿片类药物使用障碍药物相关的口腔并发症的风险比较：混合方法

基本信息

批准号：
10765049
负责人：
Anne Mobley Butler
金额：
$ 127.51万
依托单位：
UNIVERSITY OF PITTSBURGH AT PITTSBURGH
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-21 至 2025-09-20
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10765049
关键词：
Accounting Address Adherence Adverse event Attitude Benefits and Risks Buprenorphine Case Series Case Study Cessation of life Characteristics Clinical Communication Data Data Set Databases Decision Making Dental Edentulous Mouth Education Ensure Epidemiologic Methods Etiology Evaluation Formulation Fostering Goals Health Health Services Research Healthcare Helping to End Addiction Long-term Hour Individual Injectable Intervention Interview Knowledge Life Link Medicaid Medical Medicine Methadone Methodology Methods Modernization Morbidity - disease rate Mucous Membrane Naltrexone Observational Study Oral Oral health Outcome Overdose Pain Patients Persons Pharmaceutical Preparations Population Process Provider Qualitative Methods Radar Recommendation Reporting Risk Safety Salivary Sampling Selection Bias Structure System Testing Tooth Extraction Tooth structure Traction United States Food and Drug Administration United States National Institutes of Health Writing Xerostomia active comparator addiction case finding clinical practice comparative comparative safety design empowerment equilibration disorder experience health care service utilization human centered design illicit opioid innovation long term abstinence medication for opioid use disorder medication safety microbial mortality opioid epidemic opioid use opioid use disorder oral care oral infection pilot test prototype risk mitigation safety study social stigma sugar treatment choice uptake usability

项目摘要

Project Summary/Abstract Combating the opioid epidemic is a federal priority. While medications for opioid use disorder (MOUD) substantially reduce mortality, treatment uptake remains low due to multiple barriers, including societal stigma as well as patient and provider safety concerns. In January 2022, the US Food and Drug Administration (FDA) released a Drug Safety Communication warning that transmucosal buprenorphine for opioid use disorder (OUD) and pain may be associated with dental problems. This Communication was based on case reports and adverse events reporting. In the absence of rigorous evidence, several addiction medicine organizations jointly wrote to the FDA recommending retraction of the Communication due to overwhelming benefit of buprenorphine and “flawed analysis regarding causation.” As a result, the FDA Communication may contribute to barriers for MOUD initiation without rigorous data that demonstrates a causal effect of MOUD on oral complications. Evaluation of the dental safety of MOUD is urgently needed to inform clinical practice and support or refute concerning findings from case series, adverse event reports, and experience of people with opioid use disorder (PWOUD). The lack of understanding of the effects of MOUD on oral complications is a critical information gap, as patients and providers need rigorous evidence to make informed treatment choices and take steps to mitigate risk of poor dental health. We will conduct an observational study using national databases, including linked dental and medical claims data for more than 120,000 Medicaid- or commercially-insured new users of MOUD to treat OUD. Next, we will use qualitative methods to examine the perspectives of PWOUD on the oral health impact of MOUD, the FDA Communication, and barriers to obtaining oral health care. Lastly, we will develop an educational aid using human-centered design activities to inform discussions of the risks and benefits associated with MOUD and oral complications. This large study will generate evidence to address critical gaps in knowledge about the impact of MOUD on adverse oral health outcomes and leverage human-centered design to create an educational aid for patients. Our results will empower PWOUD to seek effective dental treatment and foster high-quality, risk-benefit discussions around MOUD that removes barriers to receiving their life-saving treatment.

项目摘要/摘要打击阿片类药物流行是联邦优先事项。而阿片类药物使用的药物疾病（MOUD）大大降低了死亡率，由于多个障碍，包括社会污名以及患者和提供者的安全关注。 2022年1月，美国食品药品监督管理局（FDA）发布了药物安全通讯警告阿片类药物的传播丁丙诺啡疾病（OUD）和疼痛可能与牙齿问题有关。这个交流基于案例报告和不良事件报告。在没有严格的情况下证据，几个成瘾医学组织共同写给FDA 建议由于压倒性的好处而导致的沟通撤回丁丙诺啡和“有关原因的有缺陷的分析”。结果，FDA 沟通可能会导致穆德开始的障碍，而没有严格的数据证明了穆德对口腔并发症的因果影响。评估牙科迫切需要穆德的安全来为临床实践和支持或驳斥提供信息关于病例系列的发现，不良事件报告和人们的经验与卵毒素使用障碍（Pwoud）。缺乏对穆德影响的理解由于患者和提供者需要，口服并发症是一个关键的信息差距严格的证据以做出明智的治疗选择，并采取措施减轻风险牙齿健康状况不佳。我们将使用国家数据库进行检查，包括链接的牙科和医疗索赔数据，可用于120,000多个医疗补助或 MOUD的商业保险的新用户可以治疗Oud。接下来，我们将使用定性检查Pwoud观点对MOUD口腔健康影响的观点的方法， FDA通信以及获得口腔保健的障碍。最后，我们会的使用以人为本的设计活动来开发教育援助，以告知讨论与MOUD和口服并发症相关的风险和益处。这项大型研究将产生证据，以解决有关知识的关键差距穆德对不良口腔健康结果的影响并利用以人为本的设计为患者创造教育援助。我们的结果将使Pwoud能够寻求有效的牙科治疗并培养高质量的风险效益讨论 MOUD消除了接受救生治疗的障碍。