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.

项目概要/摘要 对抗阿片类药物过量危机的一种极其重要的干预措施是丁丙诺啡，一种部分μ阿片类药物 激动剂可将用药过量死亡率降低高达 70%。丁丙诺啡经历广泛的首过效应 口服，需要舌下（SL）给药途径，从而显着提高生物利用度。 为了进一步最大化吸收，阿片类药物使用障碍 (OUD) 患者被指示等待 药物完全溶解和吸收，可能需要 5 至 10 分钟甚至更长时间，通常需要多次服用 一天几次。患者还长期接受丁丙诺啡治疗，通常持续多年。作为 因此，OUD 患者的口腔可能会大量累积暴露于 SL 丁丙诺啡 治疗期间。 2022 年，FDA 警告临床医生和患者口腔并发症可能会导致 因使用 SL 丁丙诺啡而引起的疾病，包括蛀牙、蛀牙、口腔感染和牙齿脱落。尽管 认识到丁丙诺啡在减轻阿片类药物相关不良后果风险方面的重要性， 通知建议将此类牙科并发症纳入处方信息，并包括 在丁丙诺啡治疗期间保持口腔健康的策略。不幸的是，支持的证据基础 该警告主要基于病例报告/系列。此外，由于患有 OUD 的人很少 接受牙科治疗，此类牙科问题在多大程度上是由 SL 丁丙诺啡的直接作用引起的，或者 与丁丙诺啡无关的因素仍然未知。为了满足这一需求，我们建议进行一项前瞻性的 对接受 SL 丁丙诺啡或美沙酮维持治疗的 OUD 患者进行的队列研究。 将在入组时评估口腔疾病和其他口腔健康结果的患病率，然后 在 6 个月和 12 个月时进行前瞻性重新评估。具体来说，我们将评估自我报告的口腔健康状况： 使用便携式口腔内 3D 扫描仪（也利用近红外线）来检测牙釉质损失和龋齿 红色成像技术。作为次要目标，我们将对 OUD 患者进行定性研究，以便更好地 了解接受口腔保健的促进因素和障碍。我们还将采访OUD治疗 医疗服务提供者和牙医询问如何改善 OUD 患者的口腔保健。结果 该试验将有助于设计针对预防和治疗中可改变风险因素的临床试验 OUD 患者的口腔疾病。这项创新的 R21 提案响应了 NIDA 和 NIDCR 通过研究患者口腔并发症的发展来制定计划目标和 RFA-DE-23-015 OUD 接受 SL 丁丙诺啡。