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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing's College London

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • THC
  • CBD
  • THC + CBD
  • Placebo

Treatment groups

60 Participants
are divided into 4 treatment groups

Sponsors and collaborators

King's College London

Lead sponsor

South London and Maudsley NHS Foundation Trust

Collaborator