ACTRN12618000078257已完成1 期
A study to evaluate the safety and efficacy of sublingual cannabinoid based medicineextract compared with placebo for the treatment of Insomnia
Zelda Therapeutics Limited0 个研究点目标入组 24 人开始时间: 2018年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 25 Years 至 70 Years（—）
- 性别
- All
入选标准
- •a)Has provided a dated informed consent form signed by them; and
- •b)Is willing to comply with all study procedures and be available for the duration of the study; and
- •c)Male or female aged 25 – 70 years ; and
- •d)Presence of chronic insomnia defined as self-reported difficulty initiating (latency to persistent sleep >30 min) and/or maintaining sleep (>30 mins awake, or waking >30 mins before desired waking time)) on three or more nights per week) for at least 3 months; and
- •e)Insomnia Severity Index score >10
排除标准
- •a)Untreated cardiovascular disease, arrhythmias (other than well controlled atrial fibrillation), hypertension or severe heart failure; or
- •b)History of allergies particularly to plant-based products containing terpenes, ie flavours and aromatic natural oils for example citrus, mango, lavender, thyme, cedarwood and pine products; or
- •c)Known hypersensitivity to cannabinoids; or
- •d)Currently regularly using (greater than or equal to 3 nights/days per week) psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines); or
- •e)Inability to refrain from use of psychotropic or CNS-active drugs (including cannabis, opioids, benzodiazepines) for at least one week prior to and duration of study; or
- •f)Inability to refrain from use of Cytochrome P450 inhibitors for at least one week prior to and duration of study. Examples include macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (itraconazole, ketoconazole, posaconazole, voriconazole), protease inhibitors (ritonavir, telaprevir, boceprevir), calcium channel blockers (amlopdipine), high cholesterol medication (gemfibrozil), cyclosporine, danazol, tachycardia medication (amiodarone), hypertension medication (verapamil, diltiazem), niacin (vitamin B3 greater than 1g/ day), grapefruit juice; or
- •g)Untreated metabolic disorders such as diabetes; or
- •h)Presence of severe depression, severe anxiety or other severe psychopathologic conditions based on self-report or depression scores on the DASS greater than or equal to 21, or anxiety scores on the DASS greater than or equal to 16; or
- •i)History of suicide attempt or current suicide ideation (response greater than 0 to Question 9 of PHQ-9); or
- •j)History of seizures or epilepsy; or
- •k)History of drug or alcohol abuse; or
- •l)Insomnia associated with sleep apnea (AHI greater than 15 events/hour) or movement disorders such as restless legs, periodic limb movement (PLM) (greater than 30 events/hour or greater than 5 events/hour with associated PLM arousals); or
- •m)Are currently participating in a formal behavioural therapy program to facilitate sleep; or
- •n)Current cannabis use (less than 2 months prior); or
- •o)Pregnancy or lactation; or
- •p)Inability to refrain from greater than 2 standard drinks/day of alcohol consumption for study duration; or
- •q)Inability to refrain from greater than 400mg/day of caffeine consumption for study duration; or
- •r)Shift workers or other workers and athletes who require testing and screening for cannabis products as part of their employment; or
- •s)Any person required to drive within 10 hours of dose, or those with a self-reported history of falling asleep while driving; or
- •t)Current delayed sleep phase syndrome where wake up time is regularly later than 8.00am.
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