Impact of tDCS on Cannabis Craving in Patients With Schizophrenia and Cannabis Use Disorder: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- Change in Marijuana Craving Questionnaire (MCQ)
研究概览
简要总结
This study aims to evaluate the tDCS's impact on cannabis craving in patients with schizophrenia and cannabis addiction disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
Active transcranial direct current stimulation (active tDCS)
The transcranial direct current stimulation (tDCS) with two elecrodes placed over the scalp: the anode over the L DLPFG and the cathode over the left temporo-parietal junction (L TPJ)
干预措施: tDCS (Device)
Sham tDCS
Sham Comparator: sham transcranial direct current stimulation tDCS device allows sham stimulation. tDCS device sham technology allows optimum placebo stimulation via the same stimulation impresssion than active stimulation.
Electrode placement is the same than the active arm
干预措施: tDCS (Device)
结局指标
主要结局
Change in Marijuana Craving Questionnaire (MCQ)
时间窗: 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.
次要结局
- Change in BART Analogue Risk Task score(At baseline (Visit 2) and Day 5 (V6))
- 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))
- 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))
- 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))
- change in STROOP Test score(At baseline (Visit 2) and Day 5 (V6))
- Change in Exhaled carbon monoxide concentration score(At baseline (Visit 2) and Day 5 (V6))
- 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))
- 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))
- Score to Big Five to assessed the personnality dimensions(Baseline (Visit 2))
- Urinary cannabis test(between baseline (Visit 2), Day 5 (Visit 6), 5 weeks (Visit 7), 13 weeks (Visit 8))
- Change in MCQ (Marijuana Craving Questionnaire)(At baseline (Visit 2), (Visite 6),(Visit 7) and 13 weeks (Visite 8))
- Cannabis and tobacco use assessement(At baseline (Visit 2), Day 5 (V6), 5 weeks (V7) and 13 weeks (V8))
研究者
Noomane Bouaziz, MD
Principal Investigator
Centre hospitalier de Ville-Evrard, France