NCT03448016已完成早期 1 期
Linking Nociceptive Opioid Peptide (NOP) Receptors With Relapse in Alcoholism
Rajesh Narendran1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年5月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- [C-11]NOP-1A VT
研究概览
简要总结
The goal of this study is to compare [C-11]NOP-1A binding in recently abstinent alcohol use disorders and controls
详细描述
This will allow for understanding brain stress and antistress mechanisms that underlie abuse of alcohol in humans
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males or Females
- •Fulfill DSM5 diagnosis for alcohol use disorder
- •Medically Healthy
排除标准
- •Pregnancy or lactation
- •Comorbid severe/major medical, psychiatric (such as bipolar and psychotic disorders, etc.,) and current comorbid drug use disorders (other than tobacco use and recreational marijuana use)
- •Metal implants or paramagnetic objects contained within the body which may interfere with MRI scans
- •Currently employed as a radiation worker, or participation in radiation drug research procedures within the previous year
- •Currently on any psychotropic medications that can influence nociceptin transmission in the brain
- •[B]Healthy controls
- •Inclusion Criteria:
- •Males or females
- •Absence of present or past psychiatric conditions (including alcohol or drug use disorders)
- •Medically Healthy
- •Exclusion Criteria:
- •Pregnancy of lactation
- •Medical, psychiatric or comorbid drug/alcohol use disorders
- •Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan
- •Currently employed as a radiation worker; or participation in radioactive drug research protocols within the previous year
- •Currently on any psychotropic medications that can influence nociceptin transmission in the brain
- •Family history of psychotic disorder, manic episode, drug and alcohol use disorder in first-degree relatives
研究组 & 干预措施
Alcohol use disorders
Experimental
[C-11]NOP-1A PET Scan
干预措施: [C-11] (Radiation)
Alcohol use disorders
Experimental
[C-11]NOP-1A PET Scan
干预措施: NOP-1A (Drug)
Controls
Experimental
[C-11]NOP-1A PET Scan
干预措施: [C-11] (Radiation)
Controls
Experimental
[C-11]NOP-1A PET Scan
干预措施: NOP-1A (Drug)
结局指标
主要结局
[C-11]NOP-1A VT
时间窗: Baseline
VT-Volume of distribution expressed relative to total plasma
次要结局
未报告次要终点
研究者
Rajesh Narendran
Visiting Professor in Radiology
University of Pittsburgh
研究点 (1)
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