Efficacy of High Frequency (15Hz) Repetitive Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex in Decreasing Intake in Patients With Cocaine Use Disorder: Study Protocol for a Randomized Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Cocaine intake
研究概览
简要总结
The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.
详细描述
40 patients are expected and randomized in two groups: 20 patients with active rTMS and 20 with placebo rTMS.
Visit 1: 15 days (3 weeks of 5 consecutive daily sessions and 2 days of rest) 15Hz rTMS is performed during the following days in addition to a biweekly urine drug test and VAS evaluation.
Visit 2: Changes from baseline to week 8 in cocaine intake. Evaluation of craving and of other assessments like mood and quality of life.
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
- Triple (Participant, Care Provider, 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
- •male and female patients between 18 and 65 years of age
- •patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
- •positivity to cocaine use, determined via an urine drug test
- •patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol
排除标准
- •major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
- •illiteracy or cognitive impairment disorders
- •women who are pregnant or lactating
- •other medical diseases that contraindicate rTMS treatment such as epilepsy
- •presence of devices, i.e. pace-makers or cochlear prosthesis
- •previous rTMS treatments in order to avoid confounding factors
- •patients who can not provide the written informed consent
- •DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.
结局指标
主要结局
Cocaine intake
时间窗: 8 weeks following the treatment
Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake
次要结局
- Craving first measure(8 weeks following the treatment)
- Craving second measure(8 weeks following the treatment)
研究者
Antonello Grippo
Medical Doctor
Azienda Ospedaliero-Universitaria Careggi