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Cannabis and Thought Disorder in Schizophrenia (CANDI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03608137
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : March 16, 2022
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Study Description
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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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
Actual Study Start Date : December 7, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cannabis users
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.
 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.
Active Comparator: Non- cannabis users (control group)
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Level of thought disorder [ Time Frame: one year ]
    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 :
  1. cannabis use [ Time Frame: one year ]
    cannabis use (yes vs. no; i.e., the group factor)

  2. Delta-9 tetrahydrocannabinol (THC) concentration [ Time Frame: one year ]
    Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked

  3. Cannabidiol (CBD) concentration [ Time Frame: one year ]
    Concentration of cannabidiol in the cannabis usually smoked


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608137


Contacts
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Contact: Benjamin ROLLAND, MD, PhD +33 437 915 555 benjamin.rolland@ch-le-vinatier.fr
Contact: Veronique VIAL 0033437915531 veronique.vial@ch-le-vinatier.fr

Locations
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France
Centre Hospitalier Le Vinatier Recruiting
Bron, Auvergne Rhone Alpes, France, 69678 cedex
Contact: ROLLAND BENJAMIN, MD,Ph    0033 437 915 555    benjamin.rolland@ch-le-vinatier.fr   
Contact: VIAL VERONIQUE    0033 437 915 531    veronique.vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: Benjamin ROLLAND, MD, PhD CH LE VINATIER
Study Director: Guillaume SESCOUSSE, MD CH LE VINATIER
More Information
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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT03608137    
Other Study ID Numbers: 2018-A00062-53
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: March 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
Schizophrenia ; Cannabis
Additional relevant MeSH terms:
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Marijuana Abuse
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders