TCTR20230417005已完成2 期
The Efficacy and Safety of CBD-dominant Cannabis Oil on Chronic Insomnia
Health System Research Institute0 个研究点目标入组 37 人开始时间: 2023年4月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •1. Diagnosis of primary insomnia according to the DSM -5 by a physician
- •2. Insomnia Severity Index (ISI) score greater than 30 (moderate-to-severe clinical insomnia)
- •3. Insomnia more than 3 times a week and for more than 3 months
排除标准
- •1. Shift Worker
- •2. Have a medical condition (such as chronic pain) or medication that causes insomnia
- •3. Sleep apnea (defined as Apnea Hypopnoea Index (AHI) > 30 and Oxygen Insufficiency Index (ODI) > 10) or sleep-related movement disorder, depending on the outcome of polysomnography
- •4. Advanced or delayed sleep-wake phase disorder, depending on Actigraphy results.
- •Had received any treatment for insomnia, including cognitive behavioral therapy (CBT) and CBT drugs within 3 months prior to screening or at the discretion of the physician.
- •5. Cross-country travel (2 time zones) within the past 1 month
- •6. Regular medication users including warfarin, clobazam, rifampicin, and carbamazepine.
- •7. Disorders of the heart and blood vessels that (Screened with a prescribed 12-lead ECG)
- •8. Pregnant or breastfeeding women
- •9. Have a history of psychiatric disorder in the past 12 months (except for mild symptoms of depression or anxiety) according to the Diagnostic Manual of Mental 10. 10. Disorders (DSM-5) or at the discretion of the physician.
- •11. History of suicide attempts or suicidal thoughts History of drug or alcohol abuse/dependence in the last 2 years
- •12. Have had an allergic reaction to marijuana and marijuana extracts
- •13. Have used marijuana within the past 3 months
- •14. Excessive daily caffeine use in the physician's opinion or inability to refrain from caffeine use for more than 24 hours prior to the overnight study visit.
- •15. Failed to abstain from alcohol greater than or equal to 24 hours prior to every overnight study visit.
- •16. A medical condition that results in frequent needing to get out of bed (e.g., frequent urination during the night)
- •17. A state that requires a marijuana inspection (e.g. a workplace inspection, or a court order)
研究者
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