The CANabidiol Use for RElief of Short Term Insomnia (CAN-REST). A Randomised, Double-Blind, Placebo-Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores
研究概览
简要总结
This study aims to investigate the effect of 50 mg and 100 mg per day oral CBD product versus a placebo over 8 weeks on insomnia severity in adults aged 18-65 years old with insomnia symptoms.
详细描述
This is a double-blind, randomised, parallel-group, placebo-controlled study of 8 weeks of oral CBD at 50 or 100 mg per day versus placebo in 198 participants with insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8-21. Participants will be recruited voluntarily and are able to withdraw at any time. The study will be conducted online with telehealth consults where required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind: Study staff (including the study investigators, the clinical trials coordinator and the study medical officer) and the participants will be blinded. Blinding will be maintained by the use of identical containers and labels except for the patient identification code and unique batch number.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females aged 18-65 years old, inclusive.
- •Females must be non-pregnant, non-lactating.
- •Proficient in English and have internet access and a mobile phone.
- •Insomnia symptoms as classified by an Insomnia Severity Index (ISI) score of 8 - 21 and have experienced these symptoms over the past month at pre-screening.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Provision of signed and dated informed consent form.
- •All male and females of childbearing potential must agree to use two forms of effective contraception from the time of signing informed consent until 30 days after study completion.
排除标准
- •Serious medical and/or psychiatric illnesses/disorders that will require treatment during the trial period.
- •The use of any drug known to affect sleep during the study one week prior the randomization, including:
- •Sedatives (benzodiazepines, Z drugs, agomelatine, suvorexant, sodium oxybate, sedating antidepressants, sedating antihistamines, antipsychotics, melatonin, valerian).
- •Opioids (e.g. morphine, codeine, oxycodone, methadone, buprenorphine, fentanyl, tramadol, tapentadol, hydromorphone).
- •Stimulants (e.g. methylphenidate, dexamphetamine, modafinil, phentermine).
- •Excessive caffeine use (defined as > 600mg caffeine or approximately 6 cups of caffeinated beverages a day) that, in the opinion of the medical doctor, contributes to the participant's insomnia.
- •Excessive alcohol use (defined as per NHMRC guideline, i.e. no more than four standard drinks per day on average for men, and for women, no more than two).
- •The use of cannabinoids or a cannabinoid-based medicine within 3 months prior to study Day 1 and unwillingness to abstain from recreational drug use during the study period.
- •Cannabis dependence or any other drug or alcohol dependence within the past two years.
- •Positive urine drug screen (e.g., amphetamines type substances, benzodiazepines, cannabinoids, cocaine, and opiates) at screening or Day -1 or a history of drug abuse within the past 2 years.
- •Known hypersensitivity to cannabis-based products or any of the excipients in the study drug.
- •Use of any investigational drug or involvement in another clinical trial within 30 days of screening day.
- •Use of anti-coagulant drugs such as warfarin or those known to be metabolised by CYP450 enzymes.
- •Current or ongoing treatments for insomnia (e.g. cognitive-behavioural therapy (CBT) and CNS-active drugs).
- •Obstructive sleep apnoea determined by the MAPI questionnaire or other self-reported sleep disorders.
- •Medical conditions that result in frequent sleep disturbance (e.g. nocturia).
- •History of attempted suicide in the past 12 months.
- •Clinically significant hepatic abnormalities determined by the screening blood test.
- •Shift work, jet lag or trans-meridian travel (two time zones) in the past month.
研究组 & 干预措施
50 mg CBD
50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
干预措施: 50 mg Cannabidiol (CBD) (Drug)
50 mg CBD
50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
干预措施: Placebo (Drug)
50 mg CBD
50 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Two capsules to be taken (plus two placebo capsules)
干预措施: 100 mg Cannabidiol (CBD) (Drug)
100 mg CBD
100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.
干预措施: 50 mg Cannabidiol (CBD) (Drug)
100 mg CBD
100 mg CBD to be administered as a single oral dose. Each capsule contains 25 mg CBD. Four capsules to be taken.
干预措施: 100 mg Cannabidiol (CBD) (Drug)
Placebo
Placebo capsules contain no CBD. Four capsules to be taken as a single oral dose.
干预措施: Placebo (Drug)
结局指标
主要结局
To investigate the effect of the administration of a 50mg and 100mg per day oral CBD product versus placebo over 8 weeks on insomnia severity index scores
时间窗: Baseline (week 0), week 4, week 8
Insomnia Severity Index (ISI): A 7-item tool measuring the nature, severity, and impact of insomnia over the past 2 weeks. Each item uses a 5-point Likert scale to capture a rating (0 = no problem; 4 = very severe problem) which add up to: no insomnia (0 - 7); sub-threshold insomnia (8 - 14); moderate insomnia (15 - 21); and severe insomnia (22 - 28).
次要结局
- To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on wake after sleep onset (WASO) as assessed by actigraphy.(Baseline (week 0), week 8)
- To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Anxiety as assessed by the DASS-21 questionnaire.(Baseline (week 0), Week 4, week 8)
- To determine the effect of 8 weeks of 50mg or 100mg of CBD compared to placebo on Stress as assessed by the DASS-21 questionnaire.(Baseline (week 0), Week 4, week 8)