Substance-Induced Psychosis
Conditions
Brief summary
As primary endpoint, we expect a greater reduction of cannabis use relapse symptoms in the CBD-group compared to the placebo-group. Specifically, we expect a greater mean change on the ASI scores from baseline to follow-up (6 months) in the CBD group compared to the placebo group.
Detailed description
We expect better scores, and therefore a reduction in clinical symptomatology and a better performance in cognitive tests, in the CBD-group compared to placebo-group in all the clinical and cognitive scales employed. Specifically, we expect a greater mean change on the above-mentioned scales scores from baseline to follow-up (6 months) in the CBD group compared to the placebo group., Moreover, we expect to identify a more favorable brain connectivity and neuroplasticity profile the CBD-group vs placebo-group. Specifically, we expect a greater normalization of brain structural and functional alterations from baseline to follow-up (6 months) in the CBD group compared to the placebo group.
Interventions
DRUGCBD
DRUGABILIFY 1 mg/ml oral solution
DRUGAripiprazolo Aurobindo 15 mg compresse
DRUGARIPIPRAZOLE
DRUGComposition (%w/V): Sesame oil
DRUGrefined 90
DRUG00
DRUGEthanol
DRUGanhydrous 7
DRUG91
DRUGSucralose 0
DRUG05
DRUGDL-alfa-tocopheryl acetate 0
DRUG18
DRUGRaspberry flavor 0
DRUG02.
Sponsors
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As primary endpoint, we expect a greater reduction of cannabis use relapse symptoms in the CBD-group compared to the placebo-group. Specifically, we expect a greater mean change on the ASI scores from baseline to follow-up (6 months) in the CBD group compared to the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect better scores, and therefore a reduction in clinical symptomatology and a better performance in cognitive tests, in the CBD-group compared to placebo-group in all the clinical and cognitive scales employed. Specifically, we expect a greater mean change on the above-mentioned scales scores from baseline to follow-up (6 months) in the CBD group compared to the placebo group., Moreover, we expect to identify a more favorable brain connectivity and neuroplasticity profile the CBD-group vs placebo-group. Specifically, we expect a greater normalization of brain structural and functional alterations from baseline to follow-up (6 months) in the CBD group compared to the placebo group. | — |
Countries
Italy
Outcome results
None listed