Neurocognitive Effects of Buprenorphine Among HIV+ and HIV-Opioid Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Global Neurocognitive Function
研究概览
简要总结
The purpose of this study is to examine how Buprenorphine, a form of opioid addiction treatment, changes the ability to think and reason among people addicted to opiates, who are either HIV negative or HIV positive. In addition, blood samples will be stored for HIV+ and HIV- individuals who take buprenorphine to study its effect. This study hypothesizes that the HIV positive participants will demonstrate significant improvement in thinking and reasoning ability at 3 and 6 months compared to baseline, but that their thinking and reasoning ability will still be lower than HIV negative participants. This study also hypothesizes the biomarkers in participants' blood samples will be associated with measures of change in thinking and reasoning ability.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documented HIV-serostatus
- •English-speaking
- •Age 18-60
- •Able to give voluntary, signed informed consent
- •Plan to initiate buprenorphine treatment in the next month.
排除标准
- •Over age 60: Participants over the age of 60 will be excluded, as normal age-associated cognitive changes may confound neuropsychological (NP) assessment and diagnosis of HIV-related cognitive disorders.
- •Neurologic: History of head injury with loss of consciousness for greater than 12 hours; previous penetrating skull wounds; previous brain surgery; known seizure disorder, or any other non-HIV related CNS disorders that might affect neurocognitive functioning (e.g., previous cerebrovascular accident, Parkinson's disease, multiple sclerosis, brain tumor).
- •Medical: e.g. collagen vascular disorder (e.g. lupus), oxygen requiring chronic pulmonary disease,, or end stage renal disease requiring dialysis.
- •Psychiatric: Lifetime diagnosis of schizophrenia or bipolar disorder.
- •Less than 6 years of education.
- •Acute intoxication due to alcohol or other drugs, as assessed by research staff.
- •Use of buprenorphine in the past month, either prescribed or purchased on the street.
结局指标
主要结局
Global Neurocognitive Function
时间窗: Months 3 and 6
Neurocognitive functioning in the domains of executive functioning, including decision making, processing speed, verbal memory, attention, and motor functioning
时间窗: Months 3 and 6
次要结局
未报告次要终点
研究者
Julia H. Arnsten
Prof., Dept of Medicine
Albert Einstein College of Medicine