NCT04871048 Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia
| NCT ID | NCT04871048 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-02-15 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Aurelia GAY, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Saint Etienne
Frequently Asked Questions
Who can join the NCT04871048 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04871048 currently recruiting?
Yes, NCT04871048 is actively recruiting participants. Contact the research team at aurelia.gay@chu-st-etienne.fr for enrollment information.
Where is the NCT04871048 trial being conducted?
This trial is being conducted at Bron, France, Clermont-Ferrand, France, Clermont-Ferrand, France, Dijon, France and 4 additional locations.
Who is sponsoring the NCT04871048 clinical trial?
NCT04871048 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Aurelia GAY, MD at Centre Hospitalier Universitaire de Saint Etienne. The trial plans to enroll 110 participants.
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