The Variability of Agonist and Antagonist Effects as a Function of Level of Physical Dependence
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Opiate withdrawal
研究概览
简要总结
The purpose of this study is to examine the acute agonist and antagonist effects of a full opioid agonist medication, an opioid antagonist medication, and a partial opioid agonist medication in individuals who have different levels of physical opioid dependence.
详细描述
The pharmacological effects of opioids in opioid dependent individuals can vary as a function of the characteristics of the opioid being studied (e.g., whether it is an agonist, partial agonist, or antagonist; the dose administered; and the route of administration). Another important set of factors influencing the effects produced by opioids is the characteristics of the organism to which the opioid is being administered. One such characteristic is the level of physical dependence in individuals.
Participants in this study will be maintained on different dose levels of an opioid agonist (methadone). The participant will be challenged with a prototypic opioid agonist, antagonist, and a mixed agonist-antagonist with partial agonist features in order to determine the effects that each has on the human body.
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
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active opioid dependence
- •Qualifies for opioid agonist treatment (e.g., methadone or buprenorphine)
- •Fulfills DSM-IV diagnostic criteria for opioid dependence
排除标准
- •Significant medical problems, including insulin dependent diabetes mellitus
- •Non-substance use psychiatric disorders (e.g., schizophrenia)
- •Currently seeking treatment for substance abuse
结局指标
主要结局
Opiate withdrawal
时间窗: up to one day
Opiate agonist symptoms
时间窗: up to one day
Physiologic measures
时间窗: up to one day
次要结局
未报告次要终点