Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study (CANISLEEP)
研究概览
详细说明
Rationale The stress response is a biological cascade of physiological, psychological and behavioural processes allowing individuals to detect, interpret and react to perceived or actual threat. In the modern world, sleep loss is increasingly common, can be caused by stress, and can exaggerate the stress response in otherwise healthy individuals. Previous research using sleep restriction approaches has demonstrated that a loss of sleep reliably increases physical and psychological feelings of stress. The endocannabinoid system (ECS) is a network of receptors that regulates both the stress response and sleep processes, making it a suitable target to allow the study of these processes. Cannabinoids are compounds naturally occurring in the Cannabis plant that act on the ECS.
Approach This study will investigate the effects of different cannabinoid oils on physiological and psychological measures of stress following sleep restriction.
Participants will be healthy adults between the ages of 18-60 who are currently experiencing higher than average stress. Participants will undergo a previously validated sleep restriction paradigm (sleeping for 4 hours only) prior to the experimental session. This will allow the research team to safely replicate heightened stress related to poor sleep. Participants will be enrolled in the study for a minimum of 2 days and a maximum of 9 days.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Catherine I V Bird, MSc
- 电话号码：+44(0)2032281590
- 邮箱：catherine.bird@kcl.ac.uk
学习地点
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London
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London、London、英国、SE5 8BB
- 招聘中
- The Centre for Mental Health Research and Innovation
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接触：
- Catherine Bird
- 电话号码：+44(0)2032281590
- 邮箱：catherine.bird@kcl.ac.uk
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首席研究员：
- Will Lawn, PhD
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副研究员：
- James JH Rucker, MRC Psych, PhD
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Aged 18-60
- Currently experiencing higher than average anxiety (measured by a score of ≥10 on the GAD-7)
- Able and willing to restrict their sleep to 4 hours on one occasion
- Willing to restrict alcohol and recreational drug intake during time on the study, confirmed by negative urine drug screen on the day of the experimental session
- Own a functioning phone and be able to respond to text messages
- Willing to provide GP details
- Willing to provide an emergency contact
- Able to provide written informed consent
- Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study.
Exclusion Criteria:
- Currently receiving any treatment for any psychiatric disorder (medication and/or professional psychotherapy for a mental disorder)
- Any cannabinoid use in the past 3 months, including CBD oil, medical cannabinoids or recreational cannabis/THC use
- Cannabinoid contraindications: lifetime history of psychosis, 1st degree relative with psychosis, lifetime substance use disorder (that was professionally treated)
- History of consistent (>12 months) monthly cannabis use
- Currently experiencing insomnia or irregular sleep pattern (e.g. night shift work)
- Sleep restriction contraindications (sleep apnoea, sleep movement disorder, night shift work, insomnia)
- Have excessive daily caffeine intake (>4 cups of coffee per day or equivalent)
- Unlikely to be able to complete the study procedures for any reason, as judged by the study team
- Currently pregnant or lactating
- Currently trying to conceive a child
Additional criteria which must be met on experimental visits:
- Negative urine drug screen
- Negative urine pregnancy test
- Negative alcohol breath test
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：2.5mg THC
2.5mg tetrahydrocannabinol oil
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2.5mg tetrahydrocannabinol oil
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有源比较器：300mg CBD
300mg cannabidiol oil
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300mg cannabidiol oil
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有源比较器：2.5mg THC + 300mg CBD
2.5mg THC + 300mg CBD (Combined arm)
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2.5mg THC + 300mg CBD
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安慰剂比较：Placebo
Placebo oil
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Placebo oil
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Threat-minus-safe tonic skin conductance level difference score, measured in μS
大体时间：90-150minutes post dose
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Electrodermal activity will be recorded using electrodes on the palms.
The skin conductance level is the tonic galvanic skin response, a physiological measurement of how the electrical conductivity of the skin changes in response physical stimuli (mild electric shocks)
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90-150minutes post dose
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合作者和调查者
调查人员
- 首席研究员：Will Lawn, PhD、King's College London
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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