SchizophreniaCANNAPSYSTIMNCT04871048
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia
A study testing Transcranial direct current stimulation (tDCS) active and Transcranial direct current stimulation (tDCS) non active in people with Schizophrenia and Cannabis-Induced Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia, Cannabis-Induced Disorder
- What is being tested?
- Transcranial direct current stimulation (tDCS) active and Transcranial direct current stimulation (tDCS) non active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 8 sitesFrance
- Study dates
- 15 Feb 2023to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks
- Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days
- Subjects motivated to reduce or quit their cannabis consumption
- Patients with ambulatory compulsory care may be included
Who cannot join
- Other substance use disorder, excluding nicotine, according to DSM 5 criteria
- Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder
- Inpatient hospitalization
- History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder
- Pregnancy or no contraception
- Contraindications for tDCS and/or MRI (implanted material, uncontrolled epilepsy, intracranial hypertension)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Béatrice DEYGAS contact
8 sites in 1 country
France8 sites, 8 recruiting
- Not yet recruiting
CH Le Vinatier Service universitaire d'addictologie de Lyon
Bron, 69678
Benjamin ROLLAND, PHD, (0)437915075 ext. +33, benjamin.rolland@ch-le-vinatier.fr
- Not yet recruiting
Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles
Clermont-Ferrand, 63000
Georges BROUSSE, PHD, (0)473752072 ext. +33, gbrousse@chu-clermontferrand.fr
- Not yet recruiting
CHU de Clermont-Ferrand Service de Psychiatrie
Clermont-Ferrand, 63000
Pierre-Michel LLORCA, PHD, (0)473752125 ext. +33, pmllorca@chu-clermontferrand.fr
- Not yet recruiting
Service Hospitalo-Universitaire d'Addictologie CHU de Dijon
Dijon, 21079
Benoit TROJAK, PHD, (0)380293769 ext. +33, benoit.trojak@chu-dijon.fr
- Not yet recruiting
CHU Pôle de Psychiatrie Neurologie et Rééducation
La Tronche, 38700
Mircea POLOSAN, PHD, (0)476765383 ext. +33, mpolosan@chu-grenoble.fr
- Not yet recruiting
CH Saint-Cyr-au-Mont-d'Or service de psychiatrie
Saint-Cyr-au-Mont-d'Or, 69450
Florian LE CAMUS, MD, (0)472421183 ext. +33, flecamus@ch-st-cyr69.fr
- Not yet recruiting
Centre Hospitalier Alpes Isère
Saint-Égrève, 38120
Clément DONDE, MD, (0)476564340 ext. +33, cdonde@ch-alpes-isere.fr
- Recruiting
CHU de Saint-Etienne
Saint-Priest-en-Jarez
Aurélia GAY, MD
About this study
Official title: Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study
Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.
Read the detailed description
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
- Conditions
- Schizophrenia, Cannabis-Induced Disorder
- Being tested
- Transcranial direct current stimulation (tDCS) active, Transcranial direct current stimulation (tDCS) non active
- Keywords
- dorsolateral prefrontal cortex, medial prefrontal cortex, schizophrenia, cannabis-induced disorder
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS) activeDevice
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
Transcranial direct current stimulation (tDCS) non activeDevice
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
| Study group | Role | What they receive |
|---|---|---|
| active tDCS stimulation | Experimental | Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus Receives: Device: Transcranial direct current stimulation (tDCS) active |
| sham tDCS stimulation | Sham comparator | Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure . Receives: Device: Transcranial direct current stimulation (tDCS) non active |
What is being measured
The primary outcome is the main question the study is designed to answer.
cannabis use
Percentage change in cannabis use before and after tDCS treatment
Measured: 6 months
Secondary outcomes (5)
cannabis use
Percentage change in cannabis use before and after 3 months tDCS treatment
Measured: 3 months
Change in craving scores
Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving.
Measured: 3 months and 6 months
Hospitalizations
Number of hospitalization(s) during the 6 months after tDCS sessions
Measured: 6 months
Study of structural cerebral connectivity
Cerebral MRI (only for a subgroup of patients) : Diffusion of water at the white matter level for the evaluation of structural brain connectivity in DTI mode (diffusion tensor) on
Measured: 3 months
Study of structural and functional cerebral connectivity
Cerebral MRI (only for a subgroup of patients) : Functional connectivity index evaluated by resting state default mode network (MRI) for the evaluation of functional brain connectivity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Feb 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
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.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Responsible party
- Sponsor
- Investigators
- Aurelia GAY, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871048
- Sponsor's protocol ID
- 19PH229
- Other IDs
- 2020-A02976-33
- Acronym
- CANNAPSYSTIM
- Status last verified
- May 2026
- First submitted
- 23 Apr 2021
- Last updated
- 6 May 2026
- 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 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study
- ClinicalTrials.gov ID
- NCT04871048
- Acronym / sponsor ID
- CANNAPSYSTIM / 19PH229
- Conditions
- Schizophrenia, Cannabis-Induced Disorder
- Keywords
- dorsolateral prefrontal cortex, medial prefrontal cortex, schizophrenia, cannabis-induced disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Direction Générale de l'Offre de Soins
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 May 2021 (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.
Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.
Detailed description
Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
| Arm | Type | Receives |
|---|---|---|
| active tDCS stimulation | Experimental | Device: Transcranial direct current stimulation (tDCS) activeTranscranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus |
| sham tDCS stimulation | Sham comparator | Device: Transcranial direct current stimulation (tDCS) non activeTranscranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks
- Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days
- Subjects motivated to reduce or quit their cannabis consumption
- Patients with ambulatory compulsory care may be included
Key exclusion criteria (6 listed)
- Other substance use disorder, excluding nicotine, according to DSM 5 criteria
- Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder
- Inpatient hospitalization
- History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder
- Pregnancy or no contraception
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS) activeStimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays. | Device | active tDCS stimulation |
| Transcranial direct current stimulation (tDCS) non activeThe control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures. | Device | sham tDCS stimulation |
Primary outcome
cannabis use
Time frame: 6 months
Percentage change in cannabis use before and after tDCS treatment
5 secondary outcomes
cannabis use
Time frame: 3 months
Change in craving scores
Time frame: 3 months and 6 months
Hospitalizations
Time frame: 6 months
Study of structural cerebral connectivity
Time frame: 3 months
Study of structural and functional cerebral connectivity
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Béatrice DEYGAS contact
Aurelia GAY, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) active and Transcranial direct current stimulation (tDCS) non active in people with Schizophrenia and Cannabis-Induced Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelia GAY, MD ((0)4 77 82 88 50 ext. +33, aurelia.gay@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cannabis use (time frame: 6 months). 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 6 May 2026.