The Effect of Medical Cannabis on Opioid Use for Individuals With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change in pain interference
研究概览
简要总结
The goal of this observational study is to learn how medical cannabis (MC) affects pain and the use of opioid pain medications. Participants who have chronic pain and use prescribed opioid pain medication will opt-in to using MC or not for the 3-month study. Participants who are certified in Pennsylvania will purchase specific medical cannabis products at a reduced cost from a partnering medical cannabis dispensary monthly. All participants will complete baseline, daily, and monthly assessments to observe changes across groups.
详细描述
The primary aim is to observe if individuals who have chronic pain that they are treating with opioids and medical cannabis report changes in pain severity, function, and opioid use compared to those who do not use medical cannabis.
Secondary aims include observation of whether the use of medical cannabis differentially impacts tolerability (side effects, risk of cannabis use disorder), sleep-related symptoms, or quality of life and mental health among chronic opioid users.
There will be two groups, participants who are certified to use medical cannabis and those who do not use any cannabis. All participants will complete a baseline survey to report demographics, pain, sleep, mental health, well-being, quality of life, and use of medications. Some of these questions will be repeated monthly. Participants will also receive a link via text to a daily survey to report daily prescription opioid use and medical cannabis use (if applicable) as well as pain severity and interference.
Participants who purchase medical cannabis at Ethos will be randomized and restricted to one formulation of medical cannabis (vaporization or tincture) for the study duration. They will purchase three different compositions of the specific medical cannabis formulation at a reduced cost over 3 months and the order of those compositions will be randomized. They will purchase one composition per month and they will not know which one they are purchasing. The three different compositions are:
- A composition that is predominantly THC (tetrahydrocannabinol)
- A composition that is predominantly CBD (Cannabidiol)
- A composition that is a one-to-one blend of THC and CBD
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Current diagnosis of chronic, intractable pain
- •Use of prescription opioids for longer than 90 days
- •Have a smartphone or agree to use one provided
- •English fluency
- •Medical cannabis group only: Willing to get certified by a physician to use medical cannabis in PA OR already certified but have not been using medical cannabis products regularly (daily or weekly) for longer than 30 days
- •Medical cannabis group only: Willing to accept a temporary restriction on medical cannabis products
- •Control group: Agree to continue not using cannabis for the duration of the study (3 months)
排除标准
- •Under 18 years old
- •Being under conservatorship
- •Self-reported pregnant or breastfeeding
- •Cannabis Use Disorder
- •Active treatment in methadone or buprenorphine program for Opioid Use Disorder
- •Diabetic neuropathy or chemotherapy-induced neuropathy alone
- •Medical cannabis group: Cannabis use (daily/weekly) for more than 30 days
- •Control group: Cannabis Use
研究组 & 干预措施
Control Group
Participants will not use any cannabis for the study duration.
Medical Cannabis Group
Participants will use designated medical cannabis products for the study duration.
干预措施: Medical Cannabis (Other)
结局指标
主要结局
Change in pain interference
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Assessed using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain interference
Change in pain severity
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks
Measured using Brief Pain Inventory Short Form (BPI-SF), scores 0-10 with higher scores indicating more pain severity
Change in pain
时间窗: Daily up to 12 weeks
Assessed using Pain, Enjoyment of Life and General Activity Scale (PEG Scale), scores 0-10 with higher scores indicating more pain
Change in daily use of prescription opioids
时间窗: Daily up to 12 weeks
Assessed using self-reported number of prescription opioids taken in last 24 hours
次要结局
- Change in quality of life(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change in mental health status(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Change in sleep quality(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Side effects of medical cannabis(Baseline, 4 weeks, 8 weeks, 12 weeks)