Radicle™ Sleep: A Randomized, Blinded, Controlled, Direct-to-Consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,750
- 试验地点
- 2
- 主要终点
- Change in sleep disturbance
研究概览
简要总结
A randomized, blinded, controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes
详细描述
The aim of this study is to determine the safety and effects (if any) of different single agent and combination cannabinoid formulations on self-reported sleep and health in adults (21 years of age and older) that reside in the USA. It is a virtual, direct-to-consumer study that will recruit up to 300 participants per study arm (up to 1800 total). Participants will be followed for 5 weeks as they answer electronic surveys about their health, study product usage, and its impact on their health. There are no in-person visits for this study.
After study completion, study investigators will compare the effects of each cannabinoid study product to melatonin isolate. Study investigators will also run post-hoc analyses (correcting for multiple comparisons) to evaluate the significance of health score changes within individual study product arms, and whether there were significant differences in the effect with the addition of components to comparable cannabinoid study products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 years of age and older
- •Resides in the United States
- •Endorses symptoms of sleep disturbance
- •Selects sleep disturbance as a primary reason for taking a cannabinoid product
- •Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
- •Expresses an interest in taking a study product and not knowing the product identity until the end of the study
排除标准
- •Pregnant, trying to become pregnant, or breastfeeding
- •Reports a diagnosis of liver disease
- •Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- •Unable to read and understand English
- •Lack of reliable daily access to the internet
- •Reports taking any medication that warns against grapefruit consumption
结局指标
主要结局
Change in sleep disturbance
时间窗: 4 weeks
Sleep disturbance as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance SF 8A (Scoring from 8 to 40, with higher scores translating to greater sleep disturbance. Scores are standardized to US general population \[T-score mapping\])
次要结局
- Change in overall well-being(4 weeks)
- Change in pain(4 weeks)
- Achievement of minimum clinically important difference (MCID) in sleep disturbance(4 weeks)
- Change in sleep quantity(4 weeks)
- Change in anxiety(4 weeks)