Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiol… (NCT07656350) | Clinical Trial Compass
RecruitingNot Applicable
Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
United Kingdom60 participantsStarted 2026-06-02
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves sleep restriction and challenging the endocannabinoid system — what exactly would that mean for my body during the study, and are there any risks I should know about before considering it?
2Since this is a Phase NA healthy volunteer study measuring skin conductance as a stress or arousal response, what does that tell us about how early-stage this research is, and is there any potential benefit to me personally or is this purely for scientific knowledge?
3The study involves sleep restriction as part of the protocol — how much sleep disruption would I actually experience, and could that affect my daily life, work, or health during my participation?
4Because this trial is recruiting healthy volunteers rather than people with a specific condition, would my doctor think my overall health profile makes discussing this kind of participation reasonable at this point in my life?
5Are there any medications, supplements, or lifestyle factors — like cannabis use or sleep disorders — that my doctor thinks could disqualify me or make this trial a poor fit based on what's being studied here?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Threat-minus-safe tonic skin conductance level difference score, measured in μS
. 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