RecruitingNot ApplicableNCT07656350

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

Sponsor

King's College London

Enrollment

60 participants

Start Date

Jun 2, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

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

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria9

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 Criteria14

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