South London and Maudsley NHS Foundation Trust
London, SE58AZ, United Kingdom
NCT Number: NCT04605393
This study will recruit schizophrenia patients who use cannabis recreationally. Each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing.
Participants will be administered, in a randomized order, a pre-treatment with either CBD (1000mg) orally or a matching placebo. On both experiments, participants will then inhale cannabis containing THC. The THC administration will follow a standardised inhalation procedure using a medical-grade vaporizer device.
Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences.
The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
London, SE58AZ, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Additional criteria which must be met on experimental visits:
CBD
Placebo
THC
Time frame: Baseline visit; 20 mins post-THC
Delayed verbal recall
Time frame: pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC)
Positive Subscale
Time frame: pre-CBD/placebo administration, pre-THC and 20mins post-THC
State Scale
Time frame: Baseline; 25 mins post-THC
Forward & Reverse
Time frame: Baseline; 20 mins post-THC
Immediate verbal recall
Time frame: pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC)
Negative Subscale
Time frame: pre-CBD/placebo, 90mins post CBD, pre-THC, and +10mins, +45mins, +90mins post-THC inhalation, and at the end of study visit (i.e. 2-3 hours post-THC)
Time frame: pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC)
Time frame: pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC)
Time frame: End of Experiment 2
At the end of the final experimental visit (i.e. 2-3 hours post-THC), participants will be asked to order the two experimental visits according to which drug combination they found most pleasurable.
Time frame: Baseline visit; 30 mins post-THC
Time frame: Baseline visit; 50 mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
Time frame: pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC
King's College London
Other
Acronym: INTEGRATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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