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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/THC | Experimental | Oral placebo followed by inhalation of cannabis containing THC. |
|
| CBD/THC | Experimental | Oral CBD 1000mg followed by inhalation of cannabis containing THC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | CBD |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Verbal Learning Test | Delayed verbal recall | Baseline visit; 20 mins post-THC |
| Positive and Negative Syndrome Scale | Positive Subscale | pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC) |
| Measure | Description | Time Frame |
|---|---|---|
| State-Trait Anxiety Inventory | State Scale | pre-CBD/placebo administration, pre-THC and 20mins post-THC |
| Digit span | Forward & Reverse |
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Inclusion criteria:
Exclusion criteria:
Additional criteria which must be met on experimental visits:
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| Name | Affiliation | Role |
|---|---|---|
| Gill Dale | slam-ioppn.research@kcl.ac.uk | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley NHS Foundation Trust | London | SE58AZ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40702165 | Derived | Chesney E, Oliver D, Sarma A, Lamper AD, Slimani I, Lloyd M, Dickens AM, Welds M, Krakstrom M, Gasparini-Andre I, Oresic M, Lawn W, Babayeva N, Freeman TP, Englund A, Strang J, McGuire P. Does cannabidiol reduce the adverse effects of cannabis in schizophrenia? A randomised, double-blind, cross-over trial. Neuropsychopharmacology. 2025 Nov;50(12):1759-1767. doi: 10.1038/s41386-025-02175-3. Epub 2025 Jul 24. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2023 |
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| Drug |
Placebo |
|
| Delta-9-THC | Drug | THC |
|
| Baseline; 25 mins post-THC |
| Hopkins Verbal Learning Test | Immediate verbal recall | Baseline; 20 mins post-THC |
| Positive and Negative Syndrome Scale | Negative Subscale | pre-CBD/placebo administration, and from immediately after THC inhalation until the end of study visit (i.e. 2-3 hours post-THC) |
| Visual analogue scales |
| 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) |
| Psychotomimetic states inventory | pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC) |
| State Social Paranoia Scale | pre-CBD/placebo administration, and at the end of study visit (i.e. 2-3 hours post-THC) |
| Study drug preference | 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. | End of Experiment 2 |
| Advice Taking Task | Baseline visit; 30 mins post-THC |
| White Noise Task | Baseline visit; 50 mins post-THC |
| Plasma delta-9-tetrahydrocannabinol (THC) concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma cannabidiol (CBD) concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma THC-COOH concentraion | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma 11-COOH-THC concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma 11-OH-THC concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma 6-OH-CBD concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma anandamide concentration | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Plasma 2-arachidonoylglycerol concentration. | pre-CBD/placebo, 90mins post CBD, and 0mins, 5mins, 15mins, +90mins post-THC |
| Jul 28, 2023 |
| Prot_SAP_002.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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