Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B)

在 STD 诊所使用丁丙诺啡治疗阿片类药物使用障碍治疗联动 (OUTLAST-B)

基本信息

批准号：
9905496
负责人：
Jan Gryczynski
金额：
$ 69.45万
依托单位：
FRIENDS RESEARCH INSTITUTE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-15 至 2024-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9905496
关键词：
Accident and Emergency department Adherence Admission activity Antibiotics Appointment Biological Markers Buprenorphine Caring Centers for Disease Control and Prevention (U.S.)Clinic Clinic Visits Communities Coupled Data Drug usage Effectiveness Epidemic Event Exposure to Fentanyl Funding HIV HIV Infections Health Health Services Heroin High Prevalence Hospitals Hotlines Individual Intake Interview Jail Lead Link Medical Methods Morbidity - disease rate Naloxone National Institute of Drug Abuse Nurse Practitioners Opiate Addiction Opioid Analgesics Outcome Outpatients Overdose Participant Patients Pharmaceutical Preparations Physician Assistants Physicians Population Provider Public Health Randomized Clinical Trials Regimen Reporting Research Research Design Resources Risk Risk Behaviors Services Sexually Transmitted Diseases Statutes and Laws Structure Substance Use Disorder Testing Time United States Walking arm authority buprenorphine treatment care seeking cost effective therapy experience follow-up health record high risk high risk population illicit opioid innovation meetings mortality novel novel strategies opioid epidemic opioid use opioid use disorder overdose death overdose prevention patient population primary outcome public health emergency sexual HIV transmission treatment as usual treatment program treatment services trial comparing usual care arm waiver

项目摘要

Abstract Untreated opioid use disorder (OUD) is a continuing public health emergency in the United States. OUD is associated with significant morbidity and mortality, including overdose death. Buprenorphine is an effective treatment for OUD, but most individuals who need such treatment do not access it. Public STD clinics are high-volume, episodic care medical settings that serve a high-risk population, often on a walk-in basis. STD clinic patients have high prevalence of OUD and health-risking behaviors. This proposed study, entitled Opioid Use Disorder Treatment Linkage at STD Clinics using Buprenorphine (OUTLAST-B), will examine OUD treatment linkage strategies for opioid-dependent patients seeking services at public STD clinics. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with STD-clinic initiated buprenorphine (PN+BUP). The UC Arm will include standard services at the STD clinic. The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment. The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the STD clinic’s buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community. Research assessments consisting of a structured interview battery and biomarkers for drug use and STDs will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes. This innovative study could identify new approaches to engaging a high-risk patient population in OUD treatment. The study could have high impact because findings could be scaled to STD clinics throughout the nation, spurring novel integration across two traditionally separate service sectors of STD care and OUD treatment.

抽象的未经治疗的阿片类药物使用障碍 (OUD) 是美国持续存在的公共卫生紧急情况。与显着的发病率和死亡率相关，包括过量服用丁丙诺啡是一种有效的药物。 OUD 的治疗，但大多数需要这种治疗的人无法获得这种治疗。公立性病诊所是为高危人群提供服务的大容量、间歇性护理医疗机构，通常以未经预约的 STD 诊所患者 OUD 和健康风险行为的患病率很高。这项拟议的研究题为使用丁丙诺啡在性病诊所进行阿片类药物使用障碍治疗联系 (OUTLAST-B)，将研究针对寻求服务的阿片类药物依赖患者的 OUD 治疗联动策略这项三组平行随机临床试验 (RCT) 将比较普通护理 (UC) 与常规护理 (UC)。通过患者导航 (PN) 转诊，与使用 STD 诊所启动的丁丙诺啡 (PN+BUP) 进行患者导航。 UC Arm 将包括 STD 诊所的标准服务 PN Arm 将包括所有 UC Arm 服务，增加一名患者导航员，帮助参与者选择社区 OUD 治疗计划，促进入院预约，帮助解决障碍并协调 OUD 治疗进入，以及支持早期保留 OUD 治疗。 PN+BUP Arm 将包括所有 PN Arm 服务，此外还有其他服务。与性病诊所的丁丙诺啡豁免提供者（通常是执业护士）会面以启动丁丙诺啡治疗，作为在社区成功转移到 OUD 治疗之前的桥梁。由结构化访谈组和吸毒和性传播疾病生物标志物组成的研究评估将将在基线、3 个月和 6 个月的随访中进行 12 个月的检查。该研究将通过健康记录链接方法检查参与者的结果：(1) OUD 治疗进入和保留，(2) 阿片类药物的使用和相关问题（包括致命和非致命过量）， (3) HIV/STD 相关结果。这项创新研究可以确定让高风险患者群体参与 OUD 的新方法这项研究可能会产生很大的影响，因为研究结果可以扩展到整个性病诊所。促进性病护理和 OUD 这两个传统上独立的服务部门的新整合治疗。