Clinical trial NCT04871048: Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia
Official title: Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Cannabis-Induced Disorder
Keywords: dorsolateral prefrontal cortex
medial prefrontal cortex
schizophrenia
cannabis-induced disorder
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2021-05-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: cannabis use
timeFrame: 6 months
Secondary outcomes:
measure: cannabis use
timeFrame: 3 months
measure: Change in craving scores
timeFrame: 3 months and 6 months
measure: Hospitalizations
timeFrame: 6 months
measure: Study of structural cerebral connectivity
timeFrame: 3 months
measure: Study of structural and functional cerebral connectivity
timeFrame: 3 months
Other outcomes:
Locations:
city: Bron
country: France
facility: CH Le Vinatier Service universitaire d'addictologie de Lyon
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand Service de Psychiatrie
city: Dijon
country: France
facility: Service Hospitalo-Universitaire d'Addictologie CHU de Dijon
city: La Tronche
country: France
facility: CHU Pôle de Psychiatrie Neurologie et Rééducation
city: Saint-Cyr-au-Mont-d'Or
country: France
facility: CH Saint-Cyr-au-Mont-d'Or service de psychiatrie
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
city: Saint-Égrève
country: France
facility: Centre Hospitalier Alpes Isère
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Aurelia GAY, MD
role: PRINCIPAL_INVESTIGATOR
References: