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Идёт набор NCT07656350

Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study

Без фазы С лечением Healthy Volunteer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: THC, CBD, THC + CBD, Placebo.
Кому может быть актуально
Состояния в реестре: Healthy Volunteer. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The goal of this study is to learn about the body's response to cannabis based products in sleep deprived people who are currently experiencing anxiety but are otherwise healthy.

Подробное описание

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.

Вмешательства

  • Препарат THC
    2.5mg tetrahydrocannabinol oil
  • Препарат CBD
    300mg cannabidiol oil
  • Препарат THC + CBD
    2.5mg THC + 300mg CBD
  • Препарат Placebo
    Placebo oil

Первичные конечные точки

  • Threat-minus-safe tonic skin conductance level difference score, measured in μS [Срок оценки: 90-150minutes post dose]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Великобритания · 1 центр
  • The Centre for Mental Health Research and Innovation — London

Идентификаторы

NCT: NCT07656350 · HR-25/26-54274

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗