Effect of Magnetic Stimulation Repetitive Transcranial on Impulsivity in Cocaine Dependence.
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Short PROMIS Questionnaire
研究概览
简要总结
In a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rTMS in reducing impulsivity for cocaine addicts through - Quantitative and qualitative analysis - such behavior and possible behavioral consequences related.
详细描述
reduction of the rating impulsivity
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (DSM IV, 1994; SCID-P, 1994).
- •20 days or less withdrawal
- •18-35 years old.
- •If female, to be using contraception (barrier, oral contraceptive, IUD, surgical sterilization).
- •Fixed residential address in Sao Paulo
排除标准
- •Other Mental Disorders (DSM IV, 1994; SCID-P, 1994).
- •organic brain disease, neurosurgery to implant metal clip or epilepsy.
- •severe uncontrolled clinical comorbidity.
- •use current or within last six months of psychotropic drugs in general, except for Clonazepam dose of up to four mg / day.
- •Changes clinically significant laboratory findings. 13
- •Condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study.
- •Mandate that mandating the judicial treatment for cocaine dependence
研究组 & 干预措施
Active TMS
active rTMS delivered to the left dorsolateral prefrontal cortex
干预措施: Transcranial Magnetic Stimulation (Procedure)
Placebo TMS
PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
干预措施: Placebo TMS (Procedure)
结局指标
主要结局
The Short PROMIS Questionnaire
时间窗: 2 months
The SPQ is a 160-question paper that counsellors and researchers can use to measure an individual's level of addictive tendency in each of sixteen distinct behavioural areas. Will be applied at the following times: T0 (weeks 0 - immediately prior to the rTMS) T1 (4 weeks, after four weeks of treatment with rTMS) and T2 (8 weeks, four weeks after completing treatment). The improvement rate of 10% or more, will be our primary measure of efficacy. T0 (
次要结局
未报告次要终点