NCT07656350 Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
| NCT ID | NCT07656350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | King's College London |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-06-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-60 2. Currently experiencing higher than average anxiety (measured by a score of ≥10 on the GAD-7) 3. Able and willing to restrict their sleep to 4 hours on one occasion 4. 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 5. Own a functioning phone and be able to respond to text messages 6. Willing to provide GP details 7. Willing to provide an emergency contact 8. Able to provide written informed consent 9. Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study. Exclusion Criteria: 1. Currently receiving any treatment for any psychiatric disorder (medication and/or professional psychotherapy for a mental disorder) 2. Any cannabinoid use in the past 3 months, including CBD oil, medical cannabinoids or recreational cannabis/THC use 3. Cannabinoid contraindications: lifetime history of psychosis, 1st degree relative with psychosis, lifetime substance use disorder (that was professionally treated) 4. History of consistent (\>12 months) monthly cannabis use 5. Currently experiencing insomnia or irregular sleep pattern (e.g. night shift work) 6. Sleep restriction contraindications (sleep apnoea, sleep movement disorder, night shift work, insomnia) 7. Have excessive daily caffeine intake (\>4 cups of coffee per day or equivalent) 8. Unlikely to be able to complete the study procedures for any reason, as judged by the study team 9. Currently pregnant or lactating 10. Currently trying to conceive a child Additional criteria which must be met on experimental visits: 1. Negative urine drug screen 2. Negative urine pregnancy test 3. Negative alcohol breath test
Contact & Investigator
Will Lawn, PhD
PRINCIPAL INVESTIGATOR
King's College London
Frequently Asked Questions
Who can join the NCT07656350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07656350 currently recruiting?
Yes, NCT07656350 is actively recruiting participants. Contact the research team at catherine.bird@kcl.ac.uk for enrollment information.
Where is the NCT07656350 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07656350 clinical trial?
NCT07656350 is sponsored by King's College London. The principal investigator is Will Lawn, PhD at King's College London. The trial plans to enroll 60 participants.