Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

NCT04871048 | Recruiting

• 2 other identifiers: 19PH2292020-A02976-33
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 8

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.

Conditions

Schizophrenia; Cannabis-Induced Disorder

Keywords

dorsolateral prefrontal cortex; medial prefrontal cortex; schizophrenia; cannabis-induced disorder

Outcome Measures

Primary Outcomes (1)

• cannabis use

  Percentage change in cannabis use before and after tDCS treatment

  6 months

Secondary Outcomes (5)

• cannabis use

  3 months

• Change in craving scores

  3 months and 6 months

• Hospitalizations

  6 months

• Study of structural cerebral connectivity

  3 months

• Study of structural and functional cerebral connectivity

  3 months

Study Arms (2)

active tDCS stimulation

EXPERIMENTAL

Transcranial direct current stimulation tDCS-Stimulation will be performed using a Neurocan DC-Stimulator Plus

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 .

Device: Transcranial direct current stimulation (tDCS) non active

Interventions

Transcranial direct current stimulation (tDCS) active DEVICE

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.

active tDCS stimulation

Transcranial direct current stimulation (tDCS) non active DEVICE

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.

sham tDCS stimulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (8)

CH Le Vinatier Service universitaire d'addictologie de Lyon

Bron, 69678, France

NOT YET RECRUITING

Centre Hospitalier Universitaire Service d'Addictologie et Pathologies Duelles

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

CHU de Clermont-Ferrand Service de Psychiatrie

Clermont-Ferrand, 63000, France

NOT YET RECRUITING

Service Hospitalo-Universitaire d'Addictologie CHU de Dijon

Dijon, 21079, France

NOT YET RECRUITING

CHU Pôle de Psychiatrie Neurologie et Rééducation

La Tronche, 38700, France

NOT YET RECRUITING

CH Saint-Cyr-au-Mont-d'Or service de psychiatrie

Saint-Cyr-au-Mont-d'Or, 69450, France

NOT YET RECRUITING

Centre Hospitalier Alpes Isère

Saint-Égrève, 38120, France

NOT YET RECRUITING

CHU de Saint-Etienne

Saint-Priest-en-Jarez, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Aurelia GAY, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurelia GAY, MD

CONTACT

(0)4 77 82 88 50; aurelia.gay@chu-st-etienne.fr

Béatrice DEYGAS

CONTACT

beatrice.deygas@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: * active tDCS stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, at an intensity of 2mA, for 20 minutes each. * tDCS placebo stimulation. Patients will receive 10 sessions of tDCS over 5 consecutive days, at a frequency of 2 sessions per day spaced at least two hours apart, following an identical procedure (tracking, then wearing the device for 20 minutes) but with actual stimulation provided during the first 40 seconds.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: April 23, 2021
• First Posted: May 4, 2021
• Study Start: February 15, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)