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| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5mg THC | Experimental | 2.5mg tetrahydrocannabinol oil |
|
| 300mg CBD | Active Comparator | 300mg cannabidiol oil |
|
| 2.5mg THC + 300mg CBD | Active Comparator | 2.5mg THC + 300mg CBD (Combined arm) |
|
| Placebo | Placebo Comparator | Placebo oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC | Drug | 2.5mg tetrahydrocannabinol oil |
| |
| CBD |
| Measure | Description | Time Frame |
|---|---|---|
| Threat-minus-safe tonic skin conductance level difference score, measured in μS | 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) | 90-150minutes post dose |
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Inclusion Criteria:
Exclusion Criteria:
Additional criteria which must be met on experimental visits:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine I V Bird, MSc | Contact | +44(0)2032281590 | catherine.bird@kcl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Will Lawn, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Centre for Mental Health Research and Innovation | Recruiting | London | London | SE5 8BB | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2026 | Jun 12, 2026 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Drug |
300mg cannabidiol oil |
|
| THC + CBD | Drug | 2.5mg THC + 300mg CBD |
|
| Placebo | Drug | Placebo oil |
|