NCT01908062已完成3 期
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
研究概览
简要总结
The purpose of this study is to learn how best to treat substance use disorders in an HIV clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals with opioid or alcohol use disorders.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet Diagnostic and Statistical Manual (DSM-5) criteria for moderate or severe opioid use disorder and/or alcohol use disorder.
- •Be willing to be randomized to antagonist-based therapy or treatment as usual (TAU) for treatment of opioid and/or alcohol use disorders.
- •Be HIV-infected as defined by history of positive HIV serology or HIV RNA pcr >10,000 copies/mL).
- •Be willing to establish ongoing HIV care at community treatment program(CTP) if not already receiving ongoing care.
- •Be willing to initiate antiretroviral therapy (ART) if not already prescribed ART, regardless of CD4 count.
- •Be at least 18 years old.
- •Be able to provide written informed consent and HIPAA (if applicable) for medical record abstraction.
- •Be able to communicate in English.
- •If female, be willing to take measures to avoid becoming pregnant.
排除标准
- •Individuals will be excluded from pilot study participation if they:
- •Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
- •Examples include:
- •Disabling or terminal medical illness (e.g., active opportunistic infection, uncompensated heart failure, cirrhosis or end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;
- •Severe, untreated or inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;
- •Current severe benzodiazepine or other depressant or sedative hypnotic use requiring medical detoxification;
- •Suicidal or homicidal ideation requiring immediate attention.
- •Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times upper limit of normal on screening phlebotomy. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- •Have international normalized ratio (INR) > 1.5 or platelet count <100k. Results from tests conducted within the past 30 days which are abstracted from medical record information are acceptable.
- •Have known allergy or sensitivity to naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluents.
- •Anticipate undergoing surgery during study participation.
- •Have chronic pain requiring ongoing pain management with opioid analgesics.
- •Pending legal action or other reasons that might prevent an individual from completing the study.
- •Currently pregnant or breastfeeding.
- •Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX, (e.g. excess fat tissue over the buttocks).
- •Received methadone or buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening.
- •Have taken an investigational drug in another study within 30 days of study consent.
- •Have ECG findings that, in the opinion of the study medical clinician would preclude safe participation in the study. Results from ECGs conducted within the past 30 days which are abstracted from medical record information are acceptable.
- •Have had treatment with XR-NTX for opioid or alcohol dependence in the 3 months prior to screening.
研究组 & 干预措施
Treatment as Usual
Active Comparator
The current standard of care for treatment of opioid use disorders in HIV clinics is opioid agonist therapy. HIV-infected patients with alcohol use disorders are typically referred for residential, outpatient, and self-help groups.
干预措施: Treatment As usual (Other)
Extended Release Naltrexone
Experimental
Extended release naltrexone (XR-NTX), delivered by monthly injection. Dose: 380 mg. Frequency: One injection per month, for four months. Duration: 30 days.
干预措施: Extended Release Naltrexone (Drug)
结局指标
主要结局
Number of Participants With Successful Initiation of Treatment Within 4 Weeks of Randomization
时间窗: 4 weeks
Successful induction onto XR-NTX or initiation of treatment as usual within 4 weeks of randomization.
Number of Participants Successfully Retained on Pharmacotherapy Treatment at 16 Weeks
时间窗: 16 weeks
Number of participants who received the maximum possible expected doses of XR-NTX, or the full course of recommended pharmacotherapy treatment for treatment as usual (TAU) arm.
次要结局
- HIV Viral Suppression at 16 Weeks(16 weeks)
- HIV Care Engagement(Baseline and 16 weeks)
- Mean Days of Opioid Use in Past 30 Days(Baseline and 16 weeks)
- Participant Safety: Change in Liver Enzymes Between Baseline and Week 16(Baseline and 16 weeks)
- Number of Participants With Urine Drug Screen (UDS) Positive for Opioids(Baseline and 16 weeks)
- Mean Days of Alcohol Use in Past 30 Days(Baseline and 16 weeks)
- Number of Participants With Urine Ethyl Glucuronide (EtG) Positive for Alcohol(Baseline and 16 weeks)
- Participant Safety: Any Fatal or Non-fatal Overdose Between Baseline and Week 16(16 weeks)
- Participant Safety: Precipitated Withdrawal(16 weeks)
研究者
P. Todd Korthuis, MD
Associate Professor of Medicine
Oregon Health and Science University
研究点 (2)
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