Do Discounted Vouchers for Medical Cannabis Reduce Opioid Use in Adults With Pain: A Randomized Controlled Trial (The ReLeaf-V Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Opioid analgesic use
研究概览
简要总结
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. Our study findings will have critically important implications to shape clinical care and medical cannabis policies.
详细描述
This study will examine how discounted vouchers for medical cannabis use affects opioid analgesic use in adults with chronic pain. ReLeaf-V is a 4-arm blinded randomized controlled trial (RCT) of 352 adults with (a) severe or chronic neuropathic or joint pain, (b) opioid analgesic use, and (c) active certification for medical cannabis. We will randomize participants to a discounted voucher for: 1) a placebo soft-gel capsule product, 2) high THC:low CBD soft-gel capsule product (4.3mg THC/0.7mg CBD), 3) equal THC:CBD soft-gel capsule product (2.5mg THC/2.5mg CBD), or 4) low THC:high CBD soft-gel capsule product (0.2mg THC/4.8mg CBD). Over 14 weeks, participants will have 5 research visits in which data will be collected from questionnaires, and medical and Prescription Monitoring Program (PMP) records. The primary independent variable will be randomization arm, and the primary outcome will be cumulative opioid analgesic dose.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years old
- •English or Spanish fluency
- •active certification for medical cannabis
- •intends to have a soft-gel capsule product dispensed at Vireo Health
- •medical cannabis qualifying conditions or complications of (a) chronic pain, or (b) pain that degrades health and functional capability as an alternative to opioid use or substance use disorder or (c) severe or chronic pain
- •joint or neuropathic pain
- •current severe pain
- •dispensed opioids 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
- •current or prior buprenorphine or methadone treatment for opioid use disorder
- •NYS medical marijuana prescriber does not approve changes to product and dosing recommendations listed on the participant's certification form
- •Allergy to tapioca or coconut
- •currently pregnant, planning to become pregnant within the next 3 months, or breastfeeding
- •a condition that is considered by a pharmacist or medical provider to be a clinical contraindication to medical cannabis use (e.g. unstable cardiac arrhythmia or specific drug-drug interaction)
研究组 & 干预措施
Voucher for a Discounted Placebo Product
Voucher for a Discounted Placebo Soft-Gel Capsule Product
干预措施: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products (Other)
Voucher for a Discounted High THC:Low CBD Product
Voucher for a Discounted 4.3mg THC/0.7mg CBD Soft-Gel Capsule Product
干预措施: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products (Other)
Voucher for a Discounted Equal THC:CBD Product
Voucher for a Discounted 2.5mg THC/2.5mg CBD Soft-Gel Capsule Product
干预措施: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products (Other)
Voucher for a Discounted Low THC:High CBD Product
Voucher for a Discounted 0.2mg THC/4.8mg CBD Soft-Gel Capsule Product
干预措施: Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products (Other)
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 cumulative opioid analgesic dose.
次要结局
未报告次要终点