Cannabis Use Disorder, Schizophrenia
Conditions
Keywords
cannabis use disorder, schizophrenia, cannabis, craving
Brief summary
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.
Detailed description
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.
Interventions
DEVICEtDCS
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.
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
tDCS versus sham tDCS
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marijuana Craving Questionnaire (MCQ) | At baseline (Visit 2) and Day 5 (Visit 6) | To asses variation in cannabis craving state. The minimum value is 9 and the maximum value is 63. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia | At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8) | 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. |
| Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms | At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8) | 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). |
| Change in Score of CGI (Clinical Global Impression) to clinical outcome | At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8) | CGI scale assess clinical outcome |
| Change in VAS score (visual analog scale) to assess the craving to cannabis | 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) | 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. |
| Change in VAS score (visual analog scale) to assessed the craving to nicotine | 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) | Nicotine 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. |
| Change in MCQ (Marijuana Craving Questionnaire) | At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8) | The minimum value is 9 and the maximum value is 63. |
| change in STROOP Test score | At baseline (Visit 2) and Day 5 (V6) | Stroop test assesses continuous attention and inhibition abilities |
| Change in Exhaled carbon monoxide concentration score | At baseline (Visit 2) and Day 5 (V6) | concentration assessment of monoxide de concentration |
| Urinary cannabis test | between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8) | assessemnt of cannabis presence in urine |
| Cannabis and tobacco use assessement | At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8) | Assessment of actual use of cannabis and tobacco (numbers of cigarettes, number of joints |
| Score to Big Five to assessed the personnality dimensions | Baseline (Visit 2) | The Big Five model or the big five personality factors is a tool for personality assessment : extraversion (E), agreeableness (A), conscientiousness (C), neuroticism (N) and openness (O).It is a taxonomic system that measures personality traits. The Bige Five consists of 44 items which are rated on a five-point likert scale from 1 (disagree a lot) to 5 (agree a lot). |
| Change in BART Analogue Risk Task score | At baseline (Visit 2) and Day 5 (V6) | BART Analogue Risk assesses risk taking behavior |
Countries
France
Contacts
Primary ContactBOUAZIZ Noomane, MD
Backup ContactBENCHERIF Youcef, Project manager
Outcome results
None listed