Project 1: Clinical Neurobiology of Serotonin and Addiction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Immediate Memory Task
研究概览
简要总结
The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users.
详细描述
Specific Aim 1: We will test the hypothesis that cocaine-dependent subjects will exhibit greater impulsivity than controls as determined by a battery of impulsivity measures and that impulsivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce impulsivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.
Specific Aim 2: We will test the hypothesis that cocaine-dependent subjects will exhibit greater cue reactivity than controls as determined by a modified Stroop task, and that cue reactivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce cue reactivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression.
Specific Aim 3: We will test the hypothesis that specific polymorphisms in the 5-HT2AR and/or 5-HT2CR will predict baseline impulsivity and/or cue reactivity as well as treatment response to serotonergic medications 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
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-Drug Abusing Control Subjects: Male and female subjects age 18 to 55 who do not meet current or past DSM-IV criteria for any Axis I disorder including substance abuse or dependence.
- •Cocaine Dependent Subjects: Male and female subjects age 18 to 55 who meet current DSM-IV criteria for cocaine dependence.
- •Female subjects: a negative pregnancy test.
排除标准
- •Non-Drug Abusing Control Subjects:
- •Current or past DSM-IV Axis I disorder
- •Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- •Positive HIV test.
- •For female subjects: a positive pregnancy test or breast feeding.
- •Concomitant use of prescription medications that could affect the central nervous system.
- •Active suicidal ideation.
- •Hamilton Depression or Anxiety Scale score greater than 15
- •Cocaine Dependent Subjects:
- •Current DSM-IV Axis I disorder other than substance abuse/dependence
- •Current diagnosis of other substance dependence besides cocaine.
- •Any serious non-psychiatric medical illness requiring ongoing medical treatment or which could affect the central nervous system.
- •Positive HIV test.
- •For female subjects: a positive pregnancy test or breast feeding.
- •Concomitant use of prescription medications that could affect the central nervous system.
- •Active suicidal ideation.
- •Subjects within 14 days of discontinuing a monoamine oxidase inhibitor.
- •Subjects with cardiac arrythmias.
- •Subjects with known hypersensitivity to escitalopram or citalopram, or mirtazapine
- •Hamilton Depression or Anxiety Scale score greater than
- •Current alcohol abuse or dependence.
研究组 & 干预措施
A (escitalopram)
Escitalopram
干预措施: Escitalopram (Drug)
B (placebo)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Immediate Memory Task
时间窗: after acute dose and after chronic administration
The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.
次要结局
- Attentional Bias as Measured by the Cocaine Stroop Task.(5 weeks of treatment)
- Cocaine Positive Urines(5 weeks of treatment)