PAIN: a Project Assessing the Impact of a Novel Cannabinoid Product
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in pain ratings on a Numerical Rating Scale (NRS)
研究概览
简要总结
This study is a clinical trial of a high-cannabidiol (CBD) sublingual product compared to placebo for 9 weeks in patients with chronic pain conditions. The study will assess the impact of CBD on chronic pain symptoms, conventional medication use, clinical state, quality of life, cognition, and biomarkers.
详细描述
Cannabis sativa has been used medicinally to treat a wide range of disorders for thousands of years. Cannabis is comprised of more than 100 cannabinoids, including D9-tetrahydrocannabinol (THC), the major intoxicating constituent, and cannabidiol (CBD), the major non-intoxicating constituent that has a number of potential therapeutic properties. Although a wide range of medical cannabis (MC) and hemp products (containing less than 0.3% THC) are used by consumers for a variety of medical indications, little is known about the direct impact of individual cannabinoids and constituent ratios on the symptoms that cause patients to seek treatment.
Chronic pain is one of the most common indications for MC use, and several studies have yielded compelling data suggesting that MC and its constituents may have analgesic and anti-inflammatory properties, suggesting that cannabinoids may have the potential to treat chronic pain. This investigation will involve a placebo-controlled crossover trial of a hemp-derived high-CBD, low-THC sublingual product in patients with chronic pain; patients will be assessed at baseline and over 69weeks of treatment with CBD or placebo on measures of clinical state, including pain and related symptoms, conventional medication use, and cognition, and provide samples for analysis of inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent
- •Subject is 21 or older
- •Subject is fluent in English
- •Subject endorses a musculoskeletal chronic pain condition including, but not limited to, chronic pain due to injury, arthritis (including osteoarthritis and rheumatoid arthritis), bursitis, etc.
排除标准
- •Non-fluent English speakers
- •Estimated IQ < 75
- •A history of head injury or loss of consciousness greater than 5 minutes
- •Currently uses CBD products regularly
- •Female subjects will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding
- •Presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder)
- •Primary neuropathic pain or cancer-related pain; patients experiencing neuropathic pain secondary to musculoskeletal pain will be allowed to enter the study
- •Disclosure of a genetic polymorphism affecting CYP2C9 function
研究组 & 干预措施
Cannabidiol Treatment Arm
High-CBD sublingual product administered three times daily for the treatment period.
干预措施: Cannabidiol (Drug)
Placebo Treatment Arm
Placebo sublingual product administered three times daily for the treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain ratings on a Numerical Rating Scale (NRS)
时间窗: 6 weeks
The NRS is an 11-point scale on which subjects rate their pain by choosing a number between 0 (no pain) and 10 (worst possible pain). Lower scores indicate less pain.
次要结局
- Change in ratings on the Pain Self-Efficacy Questionnaire (PSEQ)(6 weeks)
- Change in ratings on the Pain Distress Scale (PDS)(6 weeks)
- Change in ratings on the Pain Disability Index (PDI)(6 weeks)
- Change in Conventional Medication Use(6 weeks)
- Change in pain ratings on the Brief Pain Inventory (BPI)(6 weeks)
研究者
Staci Gruber, Ph.D.
Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core; Associate Professor of Psychiatry, Harvard Medical School
Mclean Hospital