Cannabis and Thought Disorder in Schizophrenia (CANDI)
Primary Purpose
Schizophrenia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia ; Cannabis
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Le VinatierRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cannabis users
Non- cannabis users (control group)
Arm Description
Subjects of this group have to meet the DSM-5 criteria for schizophrenia and smoke cannabis at least two days per week for every week of the past month. They have to exhibit negative urine screen for any substance except benzodiazepines and cannabis.
Subjects of this group have to meet the DSM-5 criteria for schizophrenia and have to report no cannabis use over the previous month, and exhibit negative urine screen for any substance except benzodiazepines.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
cannabis use
cannabis use (yes vs. no; i.e., the group factor)
Delta-9 tetrahydrocannabinol (THC) concentration
Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked
Cannabidiol (CBD) concentration
Concentration of cannabidiol in the cannabis usually smoked
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03608137
Brief Title
Cannabis and Thought Disorder in Schizophrenia
Acronym
CANDI
Official Title
Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia ; Cannabis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cannabis users
Arm Type
Experimental
Arm Description
Subjects of this group have to meet the DSM-5 criteria for schizophrenia and smoke cannabis at least two days per week for every week of the past month. They have to exhibit negative urine screen for any substance except benzodiazepines and cannabis.
Arm Title
Non- cannabis users (control group)
Arm Type
Active Comparator
Arm Description
Subjects of this group have to meet the DSM-5 criteria for schizophrenia and have to report no cannabis use over the previous month, and exhibit negative urine screen for any substance except benzodiazepines.
Intervention Type
Other
Intervention Name(s)
Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of thought disorder
Description
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
Time Frame
one year
Secondary Outcome Measure Information:
Title
cannabis use
Description
cannabis use (yes vs. no; i.e., the group factor)
Time Frame
one year
Title
Delta-9 tetrahydrocannabinol (THC) concentration
Description
Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked
Time Frame
one year
Title
Cannabidiol (CBD) concentration
Description
Concentration of cannabidiol in the cannabis usually smoked
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin ROLLAND, MD, PhD
Phone
+33 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique VIAL
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin ROLLAND, MD, PhD
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillaume SESCOUSSE, MD
Organizational Affiliation
CH LE VINATIER
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Auvergne Rhone Alpes
ZIP/Postal Code
69678 cedex
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROLLAND BENJAMIN, MD,Ph
Phone
0033 437 915 555
Email
benjamin.rolland@ch-le-vinatier.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033 437 915 531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cannabis and Thought Disorder in Schizophrenia
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