NCT03608137

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

December 7, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

3.7 years

First QC Date

July 24, 2018

Last Update Submit

February 13, 2024

Conditions

Schizophrenia

Keywords

Schizophrenia ; Cannabis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • cannabis use

    one year

  • Delta-9 tetrahydrocannabinol (THC) concentration

    one year

  • Cannabidiol (CBD) concentration

    one year

Study Arms (2)

Cannabis users

EXPERIMENTAL

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

Non- cannabis users (control group)

ACTIVE COMPARATOR

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

Interventions

Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationshipsOTHER

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.

Cannabis usersNon- cannabis users (control group)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678 cedex, France

Location

MeSH Terms

Conditions

SchizophreniaMarijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Benjamin ROLLAND, MD, PhD

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

  • Guillaume SESCOUSSE, MD

    CH LE VINATIER

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

July 31, 2018

Study Start

December 7, 2018

Primary Completion

August 19, 2022

Study Completion

December 31, 2022

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)