Cannabis-based cannabinoids and sleep-restricted stress study in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Healthy adults aged 18-60 who report above-average stress and anxiety will undergo a brief sleep restriction to 4 hours, then receive one of four treatments: THC, CBD, THC + CBD, or placebo. The study uses physiological and psychological measures to see how these cannabinoid oils affect stress responses after sleep loss. It is designed to be a short-duration, multiple-arm trial with careful screening to exclude recent cannabinoid use and psychiatric treatment. The objective is to understand how endocannabinoid-system–targeting cannabinoids interact with sleep-restricted stress in otherwise healthy individuals.

Why it matters

Who can join: the full rules

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

Where it's running

• The Centre for Mental Health Research and Innovation
  London, London, United Kingdom Recruiting

Study contacts

• Principal investigator: Will Lawn, PhD — King's College London
• Study coordinator: Catherine I V Bird, MSc
• Email: catherine.bird@kcl.ac.uk
• Phone: +44(0)2032281590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.