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临床试验/NCT00134888
NCT00134888已完成不适用

The Acute and Protracted Blockade Efficacy of Buprenorphine/Naloxone

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2000年12月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Physiological effects

研究概览

简要总结

Buprenorphine, a treatment for opioid dependence, can be mixed with naloxone, to limit abuse potential. The purpose of this study is to examine the effectiveness of buprenorphine/naloxone that is given at less than daily intervals, in order to prevent withdrawal symptoms associated with stopping opioid abuse.

详细描述

Buprenorphine and naloxone are often combined to decrease withdrawal symptoms in opioid dependent individuals. Buprenorphine/naloxone is usually given daily to individuals who are attempting to stop opioid abuse; however, research suggests that individuals may be more inclined to take medication if it is given in less than daily intervals. The purpose of this study is to examine the opioid blockade effects of buprenorphine/naloxone that is administered in less than daily doses to opioid dependent individuals.

This study will last 11 weeks. Participants will stay in a residential research unit for the duration of the study. Participants will be randomly assigned to receive different doses of daily, sublingual buprenorphine/naloxone. After a minimum of 2 weeks on each dose, participants will undergo challenge sessions on each weekday for 1 week (Monday through Friday). Challenge sessions will consist of increasing doses of intramuscular hydromorphone. During the challenge session week, buprenorphine/naloxone will be given only on Monday; a placebo will be given the rest of the week. Challenge sessions will examine the blockade effects of buprenorphine/naloxone at 2, 26, 50, 74, and 98 hours after the last active dose of buprenorphine/naloxone.

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

入选标准

  • Meets diagnostic criteria for opioid dependence
  • Qualifies for opioid substitution treatment (e.g., methadone)

排除标准

  • Significant psychiatric or physical disorder

结局指标

主要结局

Physiological effects

时间窗: up to one day

drug effects (measured at Week 11)

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 (2)

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