Cannabis and Thought Disorder in Schizophrenia

Schizophrenia Clinical Trial

— CANDI  

Official title:

Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03608137
• Other study ID #: 2018-A00062-53
• Status: Terminated
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients. The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

Description:

25 subjects with schizophrenia and current cannabis use will be recruited in the experimental group. The control group will consist of 25 subjects with schizophrenia but with no cannabis use.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: December 31, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 65
• Meeting the DSM-5 criteria for schizophrenia
• "Cannabis user" group: - Smoking at least two days per week during the previous months
• Displaying positive urine screen for cannabis
• "Non-cannabis user" group: - No episode of cannabis smoking during the previous month
• Negative urine screen for cannabis + no lifetime criteria for cannabis use disorder (assessment by an addiction specialist).

Exclusion Criteria:

• Current criteria for axis-1 psychiatric disorder other than schizophrenia
• Current criteria for any other substance use disorder except for nicotine use disorder
• Any contraindication for MRI
• Tutorship or curatorship
• Pregnant or lactating woman

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
To investigate whether the level of cannabis use in schizophrenic patients influences the symptoms of psychic disorganization via modulation of cerebral connectivity between the temporal lobe and the putamen.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Auvergne Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of thought disorder	The level of thought disorder will be investigated using the specific items of the Positive And Negative Syndrome Scale (PANSS; Kay et al., 1987) Minimum score 1 Maximum score 7	one year
Secondary	cannabis use	cannabis use (yes vs. no; i.e., the group factor)	one year
Secondary	Delta-9 tetrahydrocannabinol (THC) concentration	Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked	one year
Secondary	Cannabidiol (CBD) concentration	Concentration of cannabidiol in the cannabis usually smoked	one year