Does Medical Cannabis Reduce Opioid Use in Adults With Pain: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 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. This landmark study will be among the first to examine the effect of medical cannabis with different THC/CBD (Tetrahydrocannibinol/Cannabidiol) content on opioid use as well as adverse events.
详细描述
This study will examine how medical cannabis use affects opioid analgesic use, with particular attention to THC/CBD (Tetrahydrocannibinol/Cannabidiol) content and adverse events. We will enroll adults with (a) severe or chronic neuropathic or joint pain, (b) prescribed opioid analgesic use, (c) active certification for medical cannabis, and (d) intends to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD (Tetrahydrocannibinol:Cannabidiol) product, and a low THC:high CBD product). Over the 14 weeks, data sources will include questionnaires; medical, pharmacy, and Prescription Monitoring Program (PMP) records; and urine samples. The primary independent variable will be type of soft gel capsule product, and the primary outcome will be cumulative opioid analgesic dose.
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 99 Years（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
- •Actively certified for medical cannabis
- •Intends to have a soft-gel capsule product dispensed at Vireo
- •Medical cannabis qualifying conditions or complications of "chronic or severe pain" or "pain that degrades health and functional capability as an alternative to opioid use or substance use disorder"
- •Joint or neuropathic pain
- •Current severe pain
- •Dispensed opioid analgesics within the last 60 days
- •To maintain the integrity of the study, we do not disclose all inclusion criteria to potential participants.
排除标准
- •Inability to provide informed consent
- •Inability to complete study visits over 14 weeks
- •Terminal illness
- •Current or prior psychotic disorder
- •Buprenorphine or methadone treatment for opioid use disorder within the past year
- •Allergies to tapioca or coconut
- •Currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
- •Condition that is considered by a pharmacist or medical provider to be a contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-use interaction)
结局指标
主要结局
Opioid analgesic use
时间窗: Opioid analgesic use will be weekly cumulative dose of opioid analgesics over 14 weeks.
The primary outcome will be opioid analgesic use.
次要结局
- Adverse events(Adverse events will be over 14 weeks)