Oral complications from sublingual buprenorphine treatment: A prospective cohort study

舌下含服丁丙诺啡治疗引起的口腔并发症：一项前瞻性队列研究

• 批准号: 10765272
• 负责人: Joji Suzuki
• 金额: $ 41.98万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-09-18
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10765272
• 关键词: 3-Dimensional; Adverse event; Area; Biological Availability; Buprenorphine; Case Study; Chemicals; Classification; Clinical Trials; Cohort Studies; Dental; Dental Care; Dental Enamel; Dental caries; Dentists; Development; Elements; Enrollment; Epidemiologic Methods; Exposure to; Feedback; Funding; Future; Goals; Health Personnel; Health Status; Healthcare; Imaging technology; Incidence; Individual; Intervention; Interview; Measures; Methadone; Mouth Diseases; National Institute of Dental and Craniofacial Research; National Institute of Drug Abuse; Near-infrared optical imaging; Opioid; Opioid agonist; Oral; Oral cavity; Oral health; Outcome; Overdose reduction; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacotherapy; Population Control; Positioning Attribute; Predictive Factor; Prevalence; Principal Investigator; Prospective, cohort study; Provider; Publishing; Qualitative Methods; Questionnaires; Recommendation; Regression Analysis; Reporting; Research; Research Personnel; Risk; Risk Factors; Route; Self Assessment; Series; Structure; System; Three-Dimensional Image; Time; Tooth Attrition; Tooth Loss; Tooth structure; absorption; addiction; adverse outcome; buprenorphine treatment; combat; design; evidence base; experience; follow-up; improved; innovation; methadone treatment; modifiable risk; mortality; opioid epidemic; opioid overdose; opioid use disorder; oral infection; portability; prevent; primary outcome; prospective; recruit; risk mitigation; secondary outcome; serial imaging; stem; tool

Project summary/abstract A critically important intervention to combat the opioid overdose crisis is buprenorphine, a partial-mu opioid agonist that reduces overdose mortality by up to 70%. Buprenorphine undergoes extensive first-pass effect when taken orally, necessitating the sublingual (SL) route of administration which significantly increases bioavailability. To further maximize the absorption, patients with opioid use disorder (OUD) are instructed to wait for the medication to fully dissolve and be absorbed, which can take 5 to 10 minutes or even longer, often taken multiple times a day. Patients also remain on buprenorphine treatment for a prolonged period, often for many years. As such, the oral cavity of OUD patients may experience substantial cumulative exposure to SL buprenorphine during treatment. In 2022, the FDA warned clinicians and patients of the possibility that oral complications may arise from the use of SL buprenorphine, including tooth decay, cavities, oral infections, and tooth loss. While acknowledging the importance of buprenorphine in mitigating the risk for opioid-related adverse outcomes, the notice recommended the inclusion of such dental complications in the prescribing information, and to include strategies to maintain oral health during buprenorphine treatment. Unfortunately, the evidence-base in support of this warning is largely based on case reports/series. In addition, since individuals with OUD infrequently receive dental treatment, to what extent such dental issues arose from the direct effects of SL buprenorphine, or from factors unrelated to buprenorphine, remains unknown. To fill this need, we propose to conduct a prospective cohort study of individuals with OUD receiving either SL buprenorphine or methadone for maintenance treatment. The prevalence of oral diseases and other oral health outcomes will be assessed at enrollment, then prospectively re-assessed at 6- and 12- months. Specifically, we will assess self-reported oral health status as well as tooth enamel loss and dental caries using a portable intra-oral 3D scanner that also utilizes near infra- red imaging technology. As a secondary aim, we will conduct a qualitative study of individuals with OUD to better understand the facilitators and barriers to receiving oral health care. We will also interview OUD treatment providers and dentists to inquire about how to improve oral health care among individuals with OUD. The results from this trial will help inform the design of a clinical trial targeting modifiable risk factors in preventing and treating oral diseases among OUD patients. This innovative R21 proposal is responsive to NIDA and NIDCR programmatic goals and RFA-DE-23-015 by studying the development of oral complications among patients with OUD receiving SL buprenorphine.

项目摘要/摘要 对抗阿片类药物过量危机的至关重要的干预措施是丁丙诺啡，这是一种局部摩托学阿片类药物 激动剂将过量死亡率降低多达70％。丁丙诺啡在 口服，需要舌下（SL）给药途径，从而大大增加生物利用度。 为了进一步最大化吸收，指示患有阿片类药物使用障碍（OUD）的患者等待 完全溶解和吸收的药物可能需要5到10分钟或更长的时间，通常要服用多个 一天的时间。患者还长时间进行了多年的长时间治疗丁丙诺啡治疗。作为 这样，Oud患者的口腔可能会经历大量累积暴露于SL丁丙诺啡 治疗期间。在2022年，FDA警告临床医生和患者口腔并发症可能 由使用SL丁丙诺啡的使用，包括蛀牙，腔，口腔感染和牙齿脱落。尽管 承认丁丙诺啡在减轻阿片类药物相关的不良结果的风险中的重要性， 通知建议将这种牙齿并发症纳入处方信息中，并包括 丁丙诺啡治疗期间维持口腔健康的策略。不幸的是，支持的证据基础 此警告主要基于案例报告/系列。另外，由于很少有Oud的人 接受牙齿治疗，在多大程度上源于SL丁丙诺啡的直接影响或 从无关的因素到丁丙诺啡，仍然未知。为了满足这一需求，我们建议进行潜在的 对OUD患者接受SL丁丙诺啡或美沙酮进行维持治疗的人群研究。 注册时将评估口腔疾病和其他口腔健康结果的患病率，然后 前瞻性重新评估6个月和12个月。具体而言，我们将评估自我报告的口腔健康状况 以及使用便携式内部3D扫描仪的牙齿搪瓷损失和龋齿，该扫描仪也在近红外使用 红色成像技术。作为次要目的，我们将对具有Oud的个体进行定性研究以更好 了解接受口腔保健的促进者和障碍。我们还将采访Oud治疗 提供者和牙医询问如何在患有OUD的人之间改善口腔保健。结果 通过这项试验将有助于设计临床试验的设计，该试验针对可修改的风险因素在预防和治疗时 OUD患者的口腔疾病。该创新的R21提案对NIDA和NIDCR敏感 通过研究 OUD接收SL丁丙诺啡。