Cannabis and Thought Disorder in Schizophrenia

NCT ID: NCT03608137

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin ROLLAND, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CH LE VINATIER

Guillaume SESCOUSSE, MD

Role: STUDY_DIRECTOR

CH LE VINATIER

Locations

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Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

Other Identifiers

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2018-A00062-53

Identifier Type: -

Identifier Source: org_study_id

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