Clinical trial NCT05784961: Impact of tDCS on Cannabis Craving in Schizophrenia
Official title: Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Schizophrenia
Cannabis Use Disorder
Keywords: cannabis use disorder
schizophrenia
cannabis
craving
Lead sponsor: Centre hospitalier de Ville-Evrard, France
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: tDCS versus sham tDCS
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Marijuana Craving Questionnaire (MCQ)
timeFrame: At baseline (Visit 2) and Day 5 (Visit 6)
Secondary outcomes:
measure: Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia
timeFrame: At baseline (Visit 2) and Day 2, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
measure: Change in Score of SNS (schizophrenia negative symptoms) to assess negative symptoms
timeFrame: At baseline (Visit 2) and , Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
measure: Change in Score of CGI (Clinical Global Impression) to clinical outcome
timeFrame: At baseline (Visit 2) and, Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
measure: Change in VAS score (visual analog scale) to assess the craving to cannabis
timeFrame: 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)
measure: Change in VAS score (visual analog scale) to assessed the craving to nicotine
timeFrame: 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)
measure: Change in BART Analogue Risk Task score
timeFrame: At baseline (Visit 2) and Day 5 (V6)
measure: change in STROOP Test score
timeFrame: At baseline (Visit 2) and Day 5 (V6)
measure: Change in Exhaled carbon monoxide concentration score
timeFrame: At baseline (Visit 2) and Day 5 (V6)
measure: Urinary cannabis test
timeFrame: between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)
measure: Cannabis and tobacco use assessement
timeFrame: At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)
measure: Score to Big Five to assessed the personnality dimensions
timeFrame: Baseline (Visit 2)
measure: Change in MCQ (Marijuana Craving Questionnaire)
timeFrame: At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)
Other outcomes:
Locations:
city: Neuilly sur Marne
country: France
facility: Youcef Bencherif
city: Neuilly-sur-Marne
country: France
facility: Ch Ville Evrard
Study officials:
References: