Does Medical Cannabis Reduce Opioid Analgesics in HIV+ and HIV- Adults With Pain?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- Opioid analgesic use
研究概览
简要总结
The study will examine how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and severe adverse events.
详细描述
The overarching goal of the study is to understand how medical cannabis use affects opioid analgesic use over time, with particular attention to THC/CBD content, HIV outcomes, and adverse events. The study will include a cohort of 250 HIV+ and HIV- adults with (a) severe or chronic pain, (b) opioid analgesic use, and (c) new certification for medical cannabis. Over 18 months, participants will have 7 in-person visits every 3 months and 39 web-based questionnaires every 2 weeks. Data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program records; and urine and blood samples. Over each 2-week time period (unit of analysis), the primary exposure measure will be number of days of medical cannabis use, and the primary outcome measure will be cumulative opioid analgesic dose. Qualitative interviews will also be conducted with a subgroup of 30 participants to explore perceptions of how medical cannabis use affects opioid analgesic use. Qualitative findings will help understand the reasons underlying the findings of the cohort study.
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
- •At least 18 years of age
- •English or Spanish fluency
- •New certification for medical cannabis within 90 days
- •No medical cannabis use in the 6 months prior to certification
- •Medical cannabis qualifying complication of "chronic or severe pain"
- •Use of prescribed or illicit opioid analgesics within 30 days
排除标准
- •Inability to provide informed consent
- •Inability to complete study visits over 18 months
- •Qualifying conditions for medical cannabis in NY that are likely to cause unique pain syndromes (cancer, epilepsy, multiple sclerosis, spinal cord injury, amyotrophic lateral sclerosis, Parkinson's disease, inflammatory bowel disease, Hungtington's disease)
- •Terminal illness
- •Current or prior psychotic disorder
结局指标
主要结局
Opioid analgesic use
时间窗: Opioid analgesic use will be a cumulative dose of all opioid analgesics over each of the 39 2-week periods.
The primary outcome will combine measures of prescribed and illicit opioid analgesic use.
次要结局
- Accidents/Injuries(Accident/Injuries will be measured seven times every 3 months from baseline through 18 months..)
- Alternative measures of opioid analgesic use(Alternative measures of opioid analgesic use will be measured over each of the 39 2-week periods.)
- HIV viral load(HIV outcomes will be measured seven times every 3 months from baseline through 18 months.)
- CD4 count(CD4 count will be measured seven times every 6 months from baseline through 18 months..)
- HIV antiretroviral adherence(HIV antiretroviral adherence will be measured seven times every 3 months from baseline through 18 months..)
- Cannabis use disorder(Cannabis use disorder will be measured three times every 6 months.)
- Diversion of medical cannabis(Diversion will be measured seven times every 3 months from baseline through 18 months..)
- HIV risk behaviors(HIV risk behaviors will be measured seven times every 3 months from baseline through 18 months..)
- Non-fatal overdose(Non-fatal overdose will be measured seven times every 3 months from baseline through 18 months..)
- Death(Death will be measured 18 months after enrollment.)
- Illicit drug use(Illicit drug use will be measured seven times every 3 months from baseline through 18 months..)