Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

Schizophrenia Clinical Trial

— CANNAPSYSTIM  

Official title:

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia A Randomized Controlled Double-blind Exploratory Multicentric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04871048
• Other study ID #: 19PH229
• Secondary ID: 2020-A02976-33
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Aurelia GAY, MD
• Phone: (0)4 77 82 88 50
• Email: aurelia.gay[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Marijuana Abuse
• Schizophrenia

Intervention

Device:
• Transcranial direct current stimulation (tDCS) active
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 active
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.

Locations

Country	Name	City	State
France	CH Le Vinatier Service universitaire d'addictologie de Lyon	Bron
France	Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles	Clermont-Ferrand
France	CHU de Clermont-Ferrand Service de Psychiatrie	Clermont-Ferrand
France	Service Hospitalo-Universitaire d'Addictologie CHU de Dijon	Dijon
France	CHU Pôle de Psychiatrie Neurologie et Rééducation	La Tronche
France	CH Saint-Cyr-au-Mont-d'Or service de psychiatrie	Saint-Cyr-au-Mont-d'Or
France	Centre Hospitalier Alpes Isère	Saint-Égrève
France	CHU de Saint-Etienne	Saint-Priest-en-Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cannabis use	Percentage change in cannabis use before and after tDCS treatment	6 months
Secondary	cannabis use	Percentage change in cannabis use before and after 3 months tDCS treatment	3 months
Secondary	Change in craving scores	Marijuana Craving Questionnaire score (minimum =12, maximum = 84). The higher the score, the greater the craving.	3 months and 6 months
Secondary	Hospitalizations	Number of hospitalization(s) during the 6 months after tDCS sessions	6 months
Secondary	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	3 months
Secondary	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	3 months