A Randomised, Double-blind, Placebo-controlled, Single-dose, Crossover, Pilot Study Investigating the Effects of Cannabinol (CBN) 30 mg and 300 mg on Sleep Architecture and Next-day Function in Insomnia Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Wake After Sleep Onset (WASO)
研究概览
简要总结
This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with chronic insomnia disorder.
详细描述
This is a randomised, double-blind, placebo-controlled, three-arm, crossover, single-centre, proof-of-concept study in twenty participants with chronic insomnia disorder (as per clinician diagnosis and Insomnia Severity Index [ISI] Score ≥15). Across three overnight treatment sessions, participants will receive single dose oral liquid 30 mg cannabinol (CBN), 300 mg CBN, and matched placebo. Participants will undergo overnight sleep assessment using in-laboratory polysomnography (PSG) to examine CBN-related changes to sleep parameters; and various objective and subjective measures of sleep and next-day neurobehavioral function. Each treatment session will be separated by the two-week washout period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind: Eligible participants will be assigned to one of six possible treatment orders using a pre-populated randomisation schedule. Study staff (including the study investigators, the clinical trials coordinator and the study medical officer) and the participants will be blinded. Allocation concealment will be managed by the trial epidemiologist and drug distributor who will not have any contact with participants or involvement in day-to-day trial activities. Traditional polysomnographic (PSG) measures will be scored by a PSG technician who will not be aware of participant treatment, nor will they meet the participant. The study drug and matched placebo are expected to be identical in their visual appearance, taste, or smell. A mint-flavoured lozenge will be administered immediately prior to the study drug to mask any possible differences in taste.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 25 - 65 years of age
- •Insomnia Severity Index (ISI) score ≥ 15 at eligibility screening
- •Insomnia disorder (symptoms occurring at least 3 times per week and present for longer than 3 months) as determined by the study physician
- •Ability to take oral medication
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
排除标准
- •Medical condition or medication that is the cause of the insomnia disorder as determined by the study physician
- •Known hypersensitivity to cannabis or cannabinoid products (including if this becomes evident during the trial)
- •Reported use of cannabis or cannabinoid products within the past 3 months as confirmed by at least one negative urine drug screen (UDS) (or at the study physician's discretion)
- •Sleep apnoea (defined as Apnoea Hypopnea Index [AHI] > 15 and Oxygen Desaturation Index [ODI]>10) as confirmed by polysomnography at screening
- •Sleep-related movement disorder as determined by the study physician
- •Delayed or advanced sleep phase syndrome (based on actigraphy and sleep diary) as confirmed during screening
- •Any medical condition that produces an abnormal EEG (i.e., epilepsy, brain injury)
- •Clinically relevant cardiovascular abnormalities as determined by the study physician and a 12-lead electrocardiogram (ECG) at screening
- •Shift work or trans meridian travel (two time zones) within the last month
- •History of major psychiatric disorder in the past 12 months at the study physician's discretion, except clinically managed mild depression and/or anxiety
- •History of suicide attempt or current suicide ideation (score greater than 1 on Q9 of the Patient Health Questionnaire [PHQ-9])
- •Pregnancy or lactating. Female participants are required to complete a urine pregnancy test at screening and treatment sessions and all participants are instructed to use a reliable form of contraception throughout the study duration
- •History of drug or alcohol dependency or abuse within approximately the past 2 years
- •Use of CNS-active drugs (cannabis, amphetamines, cocaine, antidepressants, opioids, benzodiazepines) in the past 3 months as confirmed by a positive urine drug test at screening or at the study physician's discretion
- •Use of medications that may have a clinically significant impact upon the metabolism and excretion of cannabinoids as determined by the study physician (e.g., CYP450 enzyme inducers/inhibitors
- •Excessive caffeine use that in the opinion of the study physician contributes to the participant's insomnia disorder, or the inability to abstain from caffeine use 24 hours prior to each overnight sleep study
- •Inability to refrain from alcohol consumption 24 hours prior to each overnight sleep study
- •Individuals with nicotine dependence (i.e., daily smokers)
- •Medical conditions that result in frequent need to get out of bed (e.g., sleep walking, nocturia)
- •Psychological or behavioural treatment for insomnia disorder, including cognitive behavioural therapy for insomnia, within 3 months before screening (excluding sleep hygiene advice)
- •Occupational or judicially ordered drug screening
- •Has held an unrestricted driving license < 1 year
- •Cannot speak English fluently
研究组 & 干预措施
30 mg Cannabinol (CBN)
Single fixed dose administered 2 hours prior to habitual sleep onset.
干预措施: 30 mg Cannabinol (CBN) (Drug)
300 mg Cannabinol (CBN)
Single fixed dose administered 2 hours prior to habitual sleep onset.
干预措施: 300 mg Cannabinol (CBN) (Drug)
Placebo
Single fixed dose administered 2 hours prior to habitual sleep onset.
干预措施: Placebo (Drug)
结局指标
主要结局
Wake After Sleep Onset (WASO)
时间窗: Night 1
WASO measured in minutes using in-laboratory overnight polysomnography, from the first epoch after lights out until the last epoch, scored as any stage of sleep by an experienced polysomnographic technician in accordance with American Academy of Sleep Medicine (AASM) 2020 Sleep Scoring criteria (Version 2.6). Comparisons between each CBN dose versus placebo.
次要结局
- Sleep Onset Latency (SOL)(Night 1)
- Absolute Electroencephalographic (EEG) Power During Non-Rapid Eye Movement (NREM) Sleep.(Night 1)
- Traditional sleep staging(Night 1)