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Clinical Trials/NCT03608137
NCT03608137
Terminated
Not Applicable

Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships

Hôpital le Vinatier1 site in 1 country63 target enrollmentDecember 7, 2018
ConditionsSchizophrenia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Hôpital le Vinatier
Enrollment
63
Locations
1
Primary Endpoint
Level of thought disorder
Status
Terminated
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 7, 2018
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hôpital le Vinatier
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • cannabis use(one year)
  • Delta-9 tetrahydrocannabinol (THC) concentration(one year)
  • Cannabidiol (CBD) concentration(one year)

Study Sites (1)

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