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)

• 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
• 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

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.

摘要 未经治疗的阿片类药物使用障碍（OUD）是美国持续的公共卫生紧急事件。OUD是 与显著的发病率和死亡率相关，包括过量死亡。丁丙诺啡是有效的 OUD的治疗，但大多数需要这种治疗的人无法获得。 公共性病诊所是高容量的，间歇性护理的医疗机构，为高危人群提供服务，通常是在一个 无预约的性病门诊患者OUD和危害健康行为的发生率较高。 这项拟议的研究，题为阿片类药物使用障碍治疗链接在性病诊所使用丁丙诺啡 （OUTLAST-B），将研究OUD治疗联系战略，为阿片类药物依赖患者寻求服务 在公共性病诊所这项三组平行随机临床试验（RCT）将比较糖尿病护理（UC）与 通过患者导航（PN）转诊，与使用STD诊所启动的丁丙诺啡（PN+BUP）的患者导航。 UC组将包括STD诊所的标准服务。PN组将包括所有UC组服务， 增加患者导航器，帮助参与者选择社区OUD治疗 计划，促进入院预约，帮助解决障碍和协调OUD治疗进入，以及 支持OUD治疗早期保留。PN+BUP组将包括所有PN组服务， 与性病诊所的丁丙诺啡豁免提供者（通常是护士）会面， 丁丙诺啡治疗，作为一个桥梁，直到成功地转移到OUD治疗的社区。 研究评估包括一个结构化的采访电池和生物标志物的药物使用和性病将 在基线、3个月和6个月随访时进行。将在12个月内审查选定的成果 通过健康记录链接方法。该研究将审查参与者在以下领域的成果：（1）OUD （2）阿片类药物使用和相关问题（包括致命和非致命的过量）， （3）HIV/STD相关结果。 这项创新的研究可以确定新的方法来吸引OUD的高风险患者人群 治疗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。 国家，刺激了两个传统上独立的服务部门性病护理和OUD的新整合 治疗