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临床试验/NCT00000290
NCT00000290已完成1 期

Stress Hormones and Human Cocaine Use

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家开始时间: 1997年5月最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
试验地点
2
主要终点
Biochemical

研究概览

简要总结

The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.

详细描述

The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

研究设计

研究类型
Interventional
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Males between the ages of 20-
  • History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG.

排除标准

  • History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months.

结局指标

主要结局

Biochemical

Physiological measures

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (2)

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