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Official title Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study
ClinicalTrials.gov ID: NCT07656350
What this study is testing
What is THC?
THC is an investigational medicine, being studied as a potential treatment for healthy volunteer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Own a functioning phone and be able to respond to text messages
You likely can't join if
- 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...
- 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)
See the full eligibility 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
- Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.