Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia (CANNAPSYSTIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia; Cannabis-Induced Disorder
• Intervention / Treatment: Device: Transcranial direct current stimulation (tDCS) active; Device: Transcranial direct current stimulation (tDCS) non active

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 Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurelia GAY, MD; Phone Number: +33 (0)4 77 82 88 50; Email: aurelia.gay@chu-st-etienne.fr
• Study Contact Backup: Name: Béatrice DEYGAS; Email: beatrice.deygas@chu-st-etienne.fr

Study Locations

• France
  • Bron, France, 69678
    • Not yet recruiting
    • CH Le Vinatier Service universitaire d'addictologie de Lyon
    • Contact: Benjamin ROLLAND, PHD; Phone Number: +33 (0)437915075; Email: benjamin.rolland@ch-le-vinatier.fr
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles
    • Contact: Georges BROUSSE, PHD; Phone Number: +33 (0)473752072; Email: gbrousse@chu-clermontferrand.fr
  • Clermont-Ferrand, France, 63000
    • Not yet recruiting
    • CHU de Clermont-Ferrand Service de Psychiatrie
    • Contact: Pierre-Michel LLORCA, PHD; Phone Number: +33 (0)473752125; Email: pmllorca@chu-clermontferrand.fr
  • Dijon, France, 21079
    • Not yet recruiting
    • Service Hospitalo-Universitaire d'Addictologie CHU de Dijon
    • Contact: Benoit TROJAK, PHD; Phone Number: +33 (0)380293769; Email: benoit.trojak@chu-dijon.fr
  • La Tronche, France, 38700
    • Not yet recruiting
    • CHU Pôle de Psychiatrie Neurologie et Rééducation
    • Contact: Mircea POLOSAN, PHD; Phone Number: +33 (0)476765383; Email: mpolosan@chu-grenoble.fr
  • Saint-Cyr-au-Mont-d'Or, France, 69450
    • Not yet recruiting
    • CH Saint-Cyr-au-Mont-d'Or service de psychiatrie
    • Contact: Florian LE CAMUS, MD; Phone Number: +33 (0)472421183; Email: flecamus@ch-st-cyr69.fr
  • Saint-Priest-en-Jarez, France
    • Recruiting
    • CHU de Saint-Etienne
    • Contact: Aurélia GAY, MD
  • Saint-Égrève, France, 38120
    • Not yet recruiting
    • Centre Hospitalier Alpes Isère
    • Contact: Clément DONDE, MD; Phone Number: +33 (0)476564340; Email: cdonde@ch-alpes-isere.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS stimulation; Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus	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.
Sham Comparator: sham tDCS stimulation; Transcranial direct current stimulation tDCS-The control group will receive the sham stimulation following the same regimen, using the sham procedure .	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cannabis use	Percentage change in cannabis use before and after tDCS treatment	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cannabis use	Percentage change in cannabis use before and after 3 months tDCS treatment	3 months
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
Hospitalizations	Number of hospitalization(s) during the 6 months after tDCS sessions	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	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	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Direction Générale de l'Offre de Soins
• Investigators: Principal Investigator: Aurelia GAY, MD, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia; dorsolateral prefrontal cortex; medial prefrontal cortex; cannabis-induced disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Marijuana Abuse
• Other Study ID Numbers: 19PH229; 2020-A02976-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No