Cannabis Oil for Chronic Non-CancEr Pain Treatment [CONCEPT] - Alpha (α): A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 309
- 试验地点
- 2
- 主要终点
- Average Pain Score
研究概览
简要总结
Cannabis is being prescribed medically for chronic non-cancer pain despite limited evidence whether or not it works to reduce average pain in patients with chronic non-cancer pain. The cannabis plant (Cannabis sativa, Cannabis indica) consists of several hundred compounds of which, approximately 70 of which are thought to be active. The two active cannabinoids of interest in this trial are tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD). The goal of this trial is to determine whether CBD or CBD+THC reduces the average pain in participants with chronic non-cancer pain. The investigators also aim to determine whether CBD or CBD+THC is associated with a reduction in pain severity, pain interference, anxiety, depression, insomnia, opioids and use of benzodiazepines, analgesics, antidepressants, anxiolytics, or hypnotics amongst chronic non-cancer pain patients or an increase in physical functioning, physical health related role limitations, social functioning, mental functioning.
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
- 26 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Average pain score in past week of ≥ 4/10.
排除标准
- •Personal history of bipolar disorder
- •Personal or family history (first degree relative - parent of sibling) of psychotic disorders (e.g., schizophrenia)
- •Active cancer (an individual undergoing active cancer chemotherapy, radiation or surgical treatment and is deemed to not be in remission as per an oncologist's report)
- •Intention to travel internationally during the trial
- •Uncontrolled diabetes (A1C > 11)
- •Cannabis use in the past 4 weeks (recreational or medicinal)
- •Current use of illicit drugs (e.g., cocaine)
- •Current use of non-prescription opioids
- •Unable to read and write in English
- •Women who are currently pregnant or breast-feeding; or women of child-bearing age who plan to become pregnant during the trial period.
研究组 & 干预措施
CBD
10mg capsules Cannabidiol (CBD)
干预措施: CBD (Drug)
CBD+THC
10mg capsules Cannabidiol (CBD) +THC tetrahydrocannabinol (CBD 5mg + (THC)
干预措施: CBD+THC (Drug)
Placebo
10mg capsules placebo
干预措施: Placebo (Other)
结局指标
主要结局
Average Pain Score
时间窗: 12 weeks after Treatment (Week 16 of trial)
Relative change in Average Pain Score measured by the Average Pain Score ( 0=No Pain and 10=Pain as bad as you can imagine) from the Numeric Rating Scale
次要结局
- Pain Severity Score(Baseline, week 4, 8, 12 and 16)
- Physical Functioning Score(Baseline, week 4, 8, 12 and 16)
- Pain Medication(Baseline, week 4, 8, 12 and 16)
- Pain Intensity Score(Baseline, week 4, 8, 12 and 16)
- Mental Health Score(Baseline, week 4, 8, 12 and 16)
- Social Functioning Score(Baseline, week 4, 8, 12 and 16)
- Average Pain Score(Baseline, week 4, 8 and 12)
- Physical Health-related Role Limitations(Baseline, week 4, 8, 12 and 16)
- Depression Score(Baseline, week 4, 8, 12 and 16)
- Anxiety Score(Baseline, week 4, 8, 12 and 16)
- Sleep Quality(Baseline, week 4, 8, 12 and 16)
- Other non-pain prescription medications(Baseline, week 4, 8, 12 and 16)
研究者
Ramesh Zacharias
Medical Director
Hamilton Health Sciences Corporation