RecruitingNot ApplicableNCT04871048

Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Enrollment

110 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Cannabis-Induced Disorder

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether transcranial direct current stimulation (tDCS) — a gentle, non-invasive brain stimulation technique using low electrical current — can help people with schizophrenia reduce or quit cannabis use. Researchers will also use brain scans to understand how tDCS changes brain activity related to addiction. **You may be eligible if...** - You have been diagnosed with schizophrenia (per DSM-5 criteria) and your psychiatric medication has been stable for at least 4 weeks - You have moderate to severe cannabis use disorder and have used cannabis in the past 7 days - You are motivated to reduce or stop cannabis use - You are receiving outpatient (non-inpatient) psychiatric care **You may NOT be eligible if...** - You have another substance use disorder (other than nicotine) - You are currently hospitalized as an inpatient - You have a history of head injury, neurological disorder, or uncontrolled epilepsy - You have a metal implant or other contraindication to tDCS or MRI - You are pregnant or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial 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.

DEVICETranscranial 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.