Impact of tDCS on Cannabis Craving in Schizophrenia

N/ANot Yet RecruitingNCT05784961

Centre hospitalier de Ville-Evrard, France138 enrolled

Overview

This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.

The authors set up this randomized, double-blind multicenter study. 7 centers are participating in this research. After randomisation, the patient will have either the placebo or stimulation sessions, by tDCS, 5 session per day, for 5 days. The authors use the Marijuana Craving Questionnaire (MCQ) scale to determine the variation in cannabis craving and measure the impact of treatment on craving, as primary outcome. secondary objectives include assessing the effect of tDCS on the general psychopathology of schizophrenia, cannabis and tobacco addiction, and on cognitive tests assessing attention and risk taking This study will be the first known multicenter study assessing tDCS impact on cannabis craving in schizophrenia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

138

Conditions

Schizophrenia Cannabis Use Disorder

Interventions

tDCSDEVICE

tDCS will be delivered using this electrode montage: anode on the left dosolateral prefrontal cortex (L DLPFC) using F3 EEG landmark and cathode on the left temporoparietal junction (L TPJ) on the middle point between T3 and P3 EEG landmark. The stimulation will be delivered at an intensity of 2 milliamps, for 20 minutes, five times a day, with 20 min inter sessions (it will be carried out on 5 consecutive days from Monday to Friday). Each processing day corresponds to a visit of V2, V3, V4, V5 and V6.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients (male or female) aged 18-65 2. Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder" 3. Stabilized patients: total score = 80 at initial PANSS score and = 3 at the following PANSS points: * conceptual disorganization * distrust * hallucinatory behaviour * Unusual content of thought 4. Patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients) 5. Reported cannabis use greater than three times per week in the past three years 6. Signed consent to participate in research 7. Affiliation to a French social security scheme 8. Patient fluent in the French language Exclusion Criteria: 1. Presence of any other psychiatric disorder, as per DSM-5 criteria. 2. Pregnancy, possible pregnancy due to lack of contraception, breastfeeding. 3. Currently active suicidal or self-injurious ideation (suicidal or not) 4. Patients with Serious medical codition 5. Other "moderate" to "severe" addictions, according to DSM 5 criteria (excluding tobacco and coffee). 6. Contraindications to tDCS (presence of intracranial metal material, intracranial hypertension, etc.). 7. Subjects already treated by tDCS 8. Patients under legal guardianship (except under curatorship) 9. Patients under safeguard of justice

Locations (2)

Ch Ville Evrard

Neuilly-sur-Marne, France

Youcef Bencherif

Neuilly-sur-Marne, France

Outcomes

Primary Outcomes

Change in Marijuana Craving Questionnaire (MCQ)

To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63.

Time frame: At baseline (Visit 2) and Day 5 (Visit 6)

Secondary Outcomes

Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia

assessment of schizophrenia psychopathology. The minimum value is 7 and the maximum value is 49 for positive scale and negative scale. For general psychopathology, the minimum value is 16 and the maximum value is 112.

Time frame: At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms

Assessment of schizophrenia negative symptoms. The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).

Time frame: At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

Change in Score of CGI (Clinical Global Impression) to clinical outcome

CGI scale assess clinical outcome

Time frame: At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

Change in VAS score (visual analog scale) to assess the craving to cannabis

Cannabis craving status assessment. It is a ruler from 0 to 10 : 0 = absence of craving, 1-3 = low craving, 4-6 = moderate craving, 7-9 = intense craving, 10 = extreme craving.

Time frame: At baseline (Visit 2) and Day 2 (Visit 3), Day 3 (Visit 4),Day 4 (Visit 5), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)

Change in VAS score (visual analog scale) to assessed the craving to nicotine

Central Contacts

BOUAZIZ Noomane, MD

CONTACT

01 43 09 32 32 urcve@gmail.com

BENCHERIF Youcef, Project manager

CONTACT

01 43 09 32 32 y.bencherif@epsve.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.