Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Illicit Opioid Use
研究概览
简要总结
This study will assess the efficacy of an integrated outpatient treatment model for persons with opioid use disorder and injection related infections. The investigators hypothesize that outpatient antibiotic treatment coupled with comprehensive treatment for opioid use disorder will demonstrate a safe and effective way to manage patients. Results could improve the current protocols for the treatment of individuals with opioid use disorder and severe infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have opioid use disorder
- •have a severe injection related infection requiring antibiotics
- •willing to accept buprenorphine treatment
- •anticipated to be discharged home
- •require IV antibiotic therapy
排除标准
- •stroke or cerebral mycotic aneurysms preventing aortic or mitral valve surgery
- •fungal valve IE
- •requiring in-patient rehabilitation
- •current pregnancy
- •hypersensitivity or allergy to buprenorphine
- •class III or IV heart failure
- •end-stage liver or renal disease
- •any condition that may prevent the volunteer from safely participating in the study
- •self-report of desire to inject into the PICC line
- •pending legal action that could interfere with study participation
- •unsafe or unstable environment precluding safe administration of IV antibiotics
- •living more than a 60 minute drive outside of Lexington, KY
研究组 & 干预措施
Outpatient Parenteral Antibiotic Therapy (OPAT)
Patients with opioid use disorder (OUD) and severe, injection-related infections (SIRI) will be treated with buprenorphine and be discharged with outpatient parenteral antibiotic therapy (OPAT).
干预措施: Buprenorphine and Outpatient Parenteral Antibiotic Therapy (Drug)
Treatment as Usual (TAU)
Patients with OUD and severe, injection-related infections (SIRI) will receive usual care.
干预措施: Buprenorphine and standard of care antibiotic treatment (Drug)
结局指标
主要结局
Illicit Opioid Use
时间窗: 12 weeks after hospital discharge
Proportion of urine samples with negative urine drug screen for illicit opioid use
次要结局
- Abstinence From Illicit Opioid(12 weeks after hospital discharge)
- Abstinence from Injection Drug Use(12 weeks after hospital discharge)
- Outpatient Treatment Retention(12 weeks after hospital discharge)
- Completion of Recommended IV Antibiotic Therapy(up to 12 weeks (duration of IV antibiotic course as determined by treating physician))
- Injection Drug Use(12 weeks after hospital discharge)
研究者
Laura Fanucchi
Associate Professor
University of Kentucky