ACTRN12623000802606尚未招募1 期
Efficacy and Safety of Low-dose Cannabidiol for treatment of sleep disturbances in adults: A randomised, double-blind placebo-controlled study
PharmaCann Pty Ltd0 个研究点目标入组 80 人开始时间: 2023年7月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Age greater or equal to 18 years
- •Self-reported complaint of sleep disturbances that includes difficulty initiating sleep or difficulty maintaining sleep
- •Participants capable of childbearing only if using adequate contraception
- •Willingness to comply with all study procedures including IP administration protocol and required testing
- •Signed, written and informed consent
- •Participants are available for follow up
排除标准
- •Under the age of 18 years
- •Over the age of 70 years
- •Severe sleep disorder such as chronic insomnia
- •Presence of any medical, psychological or social condition that may hinder compliance
- •Pregnant or breastfeeding
- •Abnormal liver function
- •oALT >2x ULN
- •oBilirubin >1.5 x ULN or normal conjugated bilirubin
- •Abnormal renal function
- •oCalculated creatinine clearance <40 mL/min using Cockcroft-Gault formula
- •Treatment with CBD within the last 6 months
- •Concurrent treatment with medication with inhibitory or induction or substrate potential with drug metabolising enzymes CYP2C, CYP2D6 and/or CYP3A and/or drug transporter P-glycoprotein
- •Concurrent treatment with medication to assist with sleep, eg benzodiazepines, z-drugs”, melatonin
- •Concurrent treatment with medication causing sedation including sedating antihistamines (chlorpheniramine, doxylamine, etc) and opioids (morphine, oxycodone, etc).
- •Allergy to the active or inactive ingredient(s)
- •Concurrent participation in other clinical trials or use of other investigational products
研究者
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