Brain Function and Structure in Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Cocaine Use/Treatment Effectiveness Score (TES)
研究概览
简要总结
The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.
详细描述
The Specific Aims of this project are:
Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 1:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.
Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.
排除标准
- •Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
- •Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
- •Significant current suicidal or homicidal ideation
- •Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
- •Taking CNS active concomitant medications
- •Taking medications known to have significant drug interactions with the study medication
- •Having conditions of probation or parole requiring reports of drug use to officers of the court
- •Impending incarceration
- •Pregnant or breast feeding for female patients
- •Inability to read, write, or speak English
- •Having plans to leave the immediate geographical area within 3 months
- •Unwillingness or not competent to sign a written informed consent form
- •Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
- •Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
- •Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
研究组 & 干预措施
Medication (Citalopram 20mg)
Citalopram (20mg dose)
干预措施: Citalopram (Drug)
Placebo
干预措施: Placebo (Drug)
Medication (Citalopram 40mg)
Citalopram 40mg dose
干预措施: Citalopram (Drug)
结局指标
主要结局
Cocaine Use/Treatment Effectiveness Score (TES)
时间窗: 8 weeks of treatment
Number of benzoylecgonine negative urines divided by the total number of urines collected
次要结局
未报告次要终点