The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain severity
研究概览
简要总结
This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.
详细描述
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. We will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD product, and a low THC:high CBD product). Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years old
- •Diagnosis of HIV
- •Fluency in English
- •Active certification for medical cannabis
- •No medical cannabis dispensed or used within the previous 30 days
- •Intends to purchase soft-gel capsule medical cannabis at Vireo
- •ICD-10 diagnosis code for neuropathic pain, OR
- •Neuropathic pain in problem list of electronic medical record, OR
- •Neuropathic pain questionnaire-short form>0
排除标准
- •Inability to provide informed consent
- •Inability to complete 14 weeks of study visits
- •Medical cannabis use within 30 days prior to enrollment
- •Unique pain symptoms (e.g. multiple sclerosis, rheumatoid arthritis)
- •Terminal illness
- •Current or prior psychotic disorder
- •Street cannabis, opioid, cocaine, or benzodiazepine use in the past 30 days
- •Dispensed opioids of benzodiazepines within 60 days
- •Non-steroidal anti-inflammatory use within 7 days prior to enrollment
- •Steroid use within the past 14 days with duration of therapy >=21 days
结局指标
主要结局
Pain severity
时间窗: 14 weeks
self-reported pain severity measured via the Brief Pain Interference (BPI) severity scale (1-10) with higher score indicating worse pain. Measured weekly with web- or phone-based questionnaire.
次要结局
- HIV Viral load suppression(14 weeks)
- Circulating levels of inflammatory cytokines(14 weeks)
- Depression(14 weeks)
- Antiretroviral adherence(14 weeks)
- Anxiety(14 weeks)
研究者
Deepika Slawek
Assistant Professor of Medicine
Montefiore Medical Center