Impact of tDCS on Cannabis Craving in Schizophrenia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: tDCS.
- Кому может быть актуально
- Состояния в реестре: Schizophrenia, Cannabis Use Disorder. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
Обзор
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.
Подробное описание
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.
Вмешательства
- Устройство tDCS
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
Первичные конечные точки
- Change in Marijuana Craving Questionnaire (MCQ) [Срок оценки: At baseline (Visit 2) and Day 5 (Visit 6)]
Вторичные конечные точки (12)
- Change in Score of the PANSS (Positive and Negative Syndrome Scale) to assess the psychopathology of schizophrenia [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 BART Analogue Risk Task score [Срок оценки: At baseline (Visit 2) and Day 5 (V6)]
- change in STROOP Test score [Срок оценки: At baseline (Visit 2) and Day 5 (V6)]
- Change in Exhaled carbon monoxide concentration score [Срок оценки: At baseline (Visit 2) and Day 5 (V6)]
- Urinary cannabis test [Срок оценки: between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8)]
- Cannabis and tobacco use assessement [Срок оценки: At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8)]
- Score to Big Five to assessed the personnality dimensions [Срок оценки: Baseline (Visit 2)]
- Change in MCQ (Marijuana Craving Questionnaire) [Срок оценки: At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8)]
Критерии участия
Критерии включения
- Patients (male or female) aged 18-65
- Patients with schizophrenia according to DSM 5 criteria with Comorbid diagnosis of "cannabis use disorder"
- 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
- Patients without any other drug or psychotherapeutic treatment for cannabis dependence ("naive" patients)
- Reported cannabis use greater than three times per week in the past three years
- Signed consent to participate in research
- Affiliation to a French social security scheme
- Patient fluent in the French language
Критерии исключения
- Presence of any other psychiatric disorder, as per DSM-5 criteria.
- Pregnancy, possible pregnancy due to lack of contraception, breastfeeding.
- Currently active suicidal or self-injurious ideation (suicidal or not)
- Patients with Serious medical codition
- Other "moderate" to "severe" addictions, according to DSM 5 criteria (excluding tobacco and coffee).
- Contraindications to tDCS (presence of intracranial metal material, intracranial hypertension, etc.).
- Subjects already treated by tDCS
- Patients under legal guardianship (except under curatorship)
- Patients under safeguard of justice
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Франция · 2 центра
- Ch Ville Evrard — Neuilly-sur-Marne
- Youcef Bencherif — Neuilly-sur-Marne
Идентификаторы
NCT: NCT05784961 · 10477M-tCCS