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临床试验/NCT00149539
NCT00149539终止2 期

Abuse Potential of Buprenorphine/Naloxone as a Function of Maintenance Dose of Buprenorphine/Naloxone

National Institute on Drug Abuse (NIDA)1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2004年6月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
12
试验地点
1
主要终点
physiologic measures

研究概览

简要总结

Buprenorphine is a treatment for opioid dependence. Naloxone is given in addition to buprenorphine in order to limit the abuse potential that is commonly associated with buprenorphine. The purpose of this study is to determine the abuse potential of high doses of buprenorphine/naloxone in opioid dependent individuals.

详细描述

Buprenorphine, a mixed agonist-antagonist opioid (or partial agonist), is a safe and effective treatment for opioid dependence. However, there is concern that buprenorphine may be abused due to its high abuse potential. A sublingual buprenorphine/naloxone combination tablet may reduce the risk of abuse associated with buprenorphine alone. The purpose of this study is to determine the abuse potential of acute doses of buprenorphine/naloxone in individuals who are maintained on different daily doses of sublingual buprenorphine/naloxone.

Participants will be maintained on both low and high doses of buprenorphine/naloxone. They will be challenged with low- and high-dose injected buprenorphine/naloxone, as well as active and placebo controls at each maintenance dose. During study visits, physiologic, subjective, and psychomotor responses to challenge sessions will be monitored and compared to known pharmacologic effects of opioid drugs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • •Actively abusing illegal opioids
  • •Qualifies for opioid substitution treatment (e.g., methadone or buprenorphine), but not in active treatment at the time of study entry
  • •Meets DSM-IV criteria for opioid dependence

排除标准

  • •Significant medical problems (e.g., insulin dependent diabetes mellitus)
  • •Non-substance use psychiatric disorders (e.g., schizophrenia)
  • •Seeking substance abuse treatment

结局指标

主要结局

physiologic measures

时间窗: up to one day

Opiate withdrawal

时间窗: up to one day

opiate agonist symptoms

时间窗: up to one day

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (1)

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