Healthy VolunteerCANISLEEPNCT07656350
Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
A study testing THC, CBD and THC + CBD in people with Healthy Volunteer, run by King's College London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- THC, CBD and THC + CBD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Centre for Mental Health Research and Innovation
London, London, SE5 8BB
Catherine Bird, +44(0)2032281590, catherine.bird@kcl.ac.uk
Will Lawn, PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Volunteer
- Being tested
- THC, CBD, THC + CBD, Placebo
- Keywords
- THC, CBD, Cannabis, Stress, Anxiety
- Medical subject headings
- Marijuana Abuse, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THCDrug
2.5mg tetrahydrocannabinol oil
CBDDrug
300mg cannabidiol oil
THC + CBDDrug
2.5mg THC + 300mg CBD
PlaceboDrug
Placebo oil
| Study group | Role | What they receive |
|---|---|---|
| 2.5mg THC | Experimental | 2.5mg tetrahydrocannabinol oil Receives: Drug: THC |
| 300mg CBD | Active comparator | 300mg cannabidiol oil Receives: Drug: CBD |
| 2.5mg THC + 300mg CBD | Active comparator | 2.5mg THC + 300mg CBD (Combined arm) Receives: Drug: THC + CBD |
| Placebo | Placebo comparator | Placebo oil Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 90-150minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start2 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Will Lawn, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656350
- Sponsor's protocol ID
- HR-25/26-54274
- Acronym
- CANISLEEP
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
- ClinicalTrials.gov ID
- NCT07656350
- Acronym / sponsor ID
- CANISLEEP / HR-25/26-54274
- Conditions
- Healthy Volunteer
- Keywords
- THC, CBD, Cannabis, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.5mg THC | Experimental | Drug: THC2.5mg tetrahydrocannabinol oil |
| 300mg CBD | Active comparator | Drug: CBD300mg cannabidiol oil |
| 2.5mg THC + 300mg CBD | Active comparator | Drug: THC + CBD2.5mg THC + 300mg CBD (Combined arm) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oil |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THC2.5mg tetrahydrocannabinol oil | Drug | 2.5mg THC |
| CBD300mg cannabidiol oil | Drug | 300mg CBD |
| THC + CBD2.5mg THC + 300mg CBD | Drug | 2.5mg THC + 300mg CBD |
| PlaceboPlacebo oil | Drug | Placebo |
Primary outcome
Threat-minus-safe tonic skin conductance level difference score, measured in μS
Time frame: 90-150minutes post dose
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Will Lawn, PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THC, CBD and THC + CBD in people with Healthy Volunteer, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine I V Bird, MSc (+44(0)2032281590, catherine.bird@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threat-minus-safe tonic skin conductance level difference score, measured in μS (time frame: 90-150minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.