Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study (CANISLEEP)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Catherine I V Bird, MSc
- Número de teléfono: +44(0)2032281590
- Correo electrónico: catherine.bird@kcl.ac.uk
Ubicaciones de estudio
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London
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London, London, Reino Unido, SE5 8BB
- Reclutamiento
- The Centre for Mental Health Research and Innovation
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Contacto:
- Catherine Bird
- Número de teléfono: +44(0)2032281590
- Correo electrónico: catherine.bird@kcl.ac.uk
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Investigador principal:
- Will Lawn, PhD
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Sub-Investigador:
- James JH Rucker, MRC Psych, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 2.5mg THC
2.5mg tetrahydrocannabinol oil
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2.5mg tetrahydrocannabinol oil
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Comparador activo: 300mg CBD
300mg cannabidiol oil
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300mg cannabidiol oil
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Comparador activo: 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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Comparador de placebos: Placebo
Placebo oil
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Placebo oil
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Threat-minus-safe tonic skin conductance level difference score, measured in μS
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Will Lawn, PhD, King's College London
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HR-25/26-54274
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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