ACTRN12620000070932已完成1 期
Cannabidiol (CBD) treatment for insomnia: a three-week randomised controlled pilot trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
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 45 Years（—）
- 性别
- All
入选标准
- •1.Males and Females Aged 18-45 years
- •2.Insomnia Severity Index (ISI) score of 15 or more.
- •3.Self-report difficulties falling and / or staying asleep (yes)
- •4.Dissatisfaction with current sleep patterns (yes)
- •5.Sleep problems interfering with daily life (yes)
排除标准
- •1. Inability to speak or read English
- •2. Current shift worker
- •3. History of severe neurological, cardiac, endocrine, gastrointestinal, or bleeding disorders (self-report)
- •4. History of major psychiatric disorder in the past 12 months except clinically-managed mild depression
- •5. Severe current depression (BDI score of greater than or equal to 20)
- •6. Severe current anxiety (BAI score greater than or equal to 16)
- •7. Pregnancy or lactation - males and females shall be advised to use reliable contraception for the duration of drug therapy and a urine pregnancy test will be performed for female participants where necessary.
- •8. Use of any CNS-active drugs (including antidepressants, opioids, benzodiazepines) for the past 3 months or at the medical officer’s discretion
- •9. Excessive caffeine use that in the opinion of the investigator contributes to the participant's insomnia
- •10. Other pre-existing sleep disorder (restless legs syndrome, narcolepsy, parasomnias etc.) (self-report)
- •11. Used any modality of treatment for insomnia, including CBT, within 3 months before screening or at the medical doctor's discretion
- •12. History of drug or alcohol dependency or abuse within approximately the past 2 years (self-report and at medical officer’s discretion)
- •13. Probable moderate to severe obstructive sleep apnoea (STOP-BANG questionnaire)
- •14. Currently participating in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •15. Not willing to abstain from driving, riding, operating heavy machinery for 8 hours after taking the nightly treatment.
研究者
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