NCT01904487已完成1 期
Characterization of [11C]Flumazenil to Image GABA Transmission in Healthy Adult Subjects and Subjects With Alcohol Dependence
Rajesh Narendran1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2011年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- To measure changes in [11C]flumazenil binding in the brain using PET scans
研究概览
简要总结
Background:
- This study is being done to examine the role of a chemical GABA in the brain of alcohol dependent patients. GABA is the chief inhibitory neurotransmitter in the central nervous system. It helps induce relaxation and sleep and balances the brain by inhibiting over-excitation. Several studies have reported that anxiety disorders such as panic attacks, seizure disorders, and numerous other conditions including addiction, are all related to low GABA activity. Therefore, we will examine differences in GABA levels between healthy controls and subjects with alcohol addiction. Studies such as this are important to the understanding of the role of GABA in alcohol addiction.
详细描述
Objectives:
- By comparing the two PET scans (before and after tiagabine) done in the same day, we can understand more about how much GABA your brain makes and about the activity of your GABA receptors in the brain.
Eligibility:
- Individuals 18-45 years of age who are heavy drinkers or healthy controls.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control Subjects:
- •Males or Females 18-45
- •Absence of present or past psychiatric conditions (including alcohol or drug dependence)
- •A negative urine drug screen
- •Medically Healthy
- •Subjects with alcohol dependence:
- •Males or Females 18-45
- •Fulfill DSM-IV Diagnosis for Alcohol Dependence
- •Negative Urine Drug Screen
- •Negative Urine ETG/ETS
- •Medically Healthy
- •Abstinent from alcohol for a minimum of 1 month prior to scanning procedures
排除标准
- •Healthy Control Subjects:
- •Pregnancy or lactation, lack of effective birth control during 15 days before the scans
- •Presence or positive history of serious medical or neurological illness, including low hemoglobin.
- •Any use (within recent past 6 weeks) of amphetamines, opiates, cocaine, ecstasy PCP.
- •Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists.
- •Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).
- •Subjects with known hypersensitivity to flumazenil or benzodiazepines; subjects who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus or in patient who are showing signs of serious cyclic antidepressant overdose)
- •Subjects with alcohol dependence:
- •Pregnancy or lactation, lack of effective birth control during 15 days before the scans
- •Presence or positive history of serious medical or neurological illness or any cardiovascular disease, low hemoglobin
- •Any other current major axis I psychiatric diagnosis except alcohol dependence (subjects with nicotine dependence will not be excluded)
- •Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan (but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant. Dental fillings do not present a risk for MRI), as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by neuroradiologists.
- •Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year such that the total cumulative annual radiation dose (i.e., from participation in the previous research studies and this study) would exceed the radiation dose limits specified in the FDA regulations at 21 CFR 361.1, Radioactive Drugs Considered Generally Safe and Effective (i.e. annual cumulative radiation dose limit = 5 rems to gonads, blood-forming organs, lens of eye, whole body; 15 rems to other organs).
- •Subjects with known hypersensitivity to flumazenil or benzodiazepines; subjects who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus or in patient who are showing signs of serious cyclic antidepressant overdose)
研究组 & 干预措施
PET scans
Experimental
Both alcoholics and healthy controls will undergo two [11C]flumazenil PET scans: one at baseline and one post administration of 0.2 mg/kg Tiagabine.
干预措施: [11C]flumazenil (Radiation)
PET scans
Experimental
Both alcoholics and healthy controls will undergo two [11C]flumazenil PET scans: one at baseline and one post administration of 0.2 mg/kg Tiagabine.
干预措施: Tiagabine (Drug)
结局指标
主要结局
To measure changes in [11C]flumazenil binding in the brain using PET scans
时间窗: Day 1: baseline PET scan and a follow-up PET scan 0.5 hours post administration of Tiagabine
Tiagabine induced change in [C-11]flumazenil distribution volume (VT)
时间窗: 1 hour
Refer to for consensus nomenclature J Cereb Blood Flow Metab. 2007 Sep;27(9):1533-9. Epub 2007 May 9.
次要结局
未报告次要终点
研究者
Rajesh Narendran
MD
University of Pittsburgh
研究点 (1)
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