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

ConditionHealthy Volunteer

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

THC
Drug
2.5mg tetrahydrocannabinol oil
CBD
Drug
300mg cannabidiol oil
THC + CBD
Drug
2.5mg THC + 300mg CBD
Placebo
Drug
Placebo oil

Treatment groups

60 Participants

are divided into 4 treatment groups

Group A: 2.5mg THCExperimental treatment 1 intervention

Group B: 300mg CBDActive comparator 1 intervention

Group C: 2.5mg THC + 300mg CBDActive comparator 1 intervention

Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Threat-minus-safe tonic skin conductance level difference score, measured in μS

Electrodermal activity will be recorded using electrodes on the palms. The skin conductance level is the tonic galvanic skin response, a physiological measurement of how the electrical conductivity of the skin changes in response physical stimuli (mild electric shocks)

Time frame

90-150minutes post dose

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

South London and Maudsley NHS Foundation Trust

Collaborator

Source ClinicalTrials.gov

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