Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study (CANISLEEP)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Catherine I V Bird, MSc
- 電話番号：+44(0)2032281590
- メール：catherine.bird@kcl.ac.uk
研究場所
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London
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London、London、イギリス、SE5 8BB
- 募集
- The Centre for Mental Health Research and Innovation
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コンタクト：
- Catherine Bird
- 電話番号：+44(0)2032281590
- メール：catherine.bird@kcl.ac.uk
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主任研究者：
- Will Lawn, PhD
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副調査官：
- James JH Rucker, MRC Psych, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：2.5mg THC
2.5mg tetrahydrocannabinol oil
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2.5mg tetrahydrocannabinol oil
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アクティブコンパレータ：300mg CBD
300mg cannabidiol oil
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300mg cannabidiol oil
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アクティブコンパレータ：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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プラセボコンパレーター：Placebo
Placebo oil
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Placebo oil
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Threat-minus-safe tonic skin conductance level difference score, measured in μS
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Will Lawn, PhD、King's College London
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
THCの臨床試験
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Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)完了
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New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene, Inc.完了マリファナの使用