SchizophreniaCANDINCT03608137
Cannabis and Thought Disorder in Schizophrenia
A study testing Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Le Vinatier
Bron, Auvergne-Rhône-Alpes, 69678 cedex
About this study
Official title: Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships
- Keywords
- Schizophrenia ; Cannabis
- Medical subject headings
- Schizophrenia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (3)
cannabis use
cannabis use (yes vs. no; i.e., the group factor)
Measured: one year
Delta-9 tetrahydrocannabinol (THC) concentration
Concentrations of Delta-9 tetrahydrocannabinol in the cannabis usually smoked
Measured: one year
Cannabidiol (CBD) concentration
Concentration of cannabidiol in the cannabis usually smoked
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start7 Dec 2018
- Primary completion19 Aug 2022
- Study completion31 Dec 2022
Why it stopped: Terminée
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin ROLLAND, MD, PhD, Principal investigator, CH LE VINATIERGuillaume SESCOUSSE, MD, Study director, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608137
- Sponsor's protocol ID
- 2018-A00062-53
- Acronym
- CANDI
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2018
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis and Thought Disorder in Schizophrenia: Clinical and Neuroimaging Relationships
- ClinicalTrials.gov ID
- NCT03608137
- Acronym / sponsor ID
- CANDI / 2018-A00062-53
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia ; Cannabis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminée
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cannabis users | Experimental | Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationshipsSubjects 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. |
| Non- cannabis users (control group) | Active comparator | Other: Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationshipsSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationshipsTo 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. | Other | Cannabis users, Non- cannabis users (control group) |
Primary outcome
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
3 secondary outcomes
cannabis use
Time frame: one year
Delta-9 tetrahydrocannabinol (THC) concentration
Time frame: one year
Cannabidiol (CBD) concentration
Time frame: one year
Results and safety
The study was stopped early (reason given: Terminée). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin ROLLAND, MD, PhD principal investigator
CH LE VINATIER
Guillaume SESCOUSSE, MD study director
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships in people with Schizophrenia, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminée). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of thought disorder (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.