NCT00000299已完成2 期
Rapid Opiate Detoxification & Naltrexone Induction Using Bup.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Opiate withdrawal symptoms
研究概览
简要总结
The purpose of this study is to develop a clinical protocol to detoxify patients from opiates to naltrexone using buprenorphine and to develop pilot data for a grant application for a controlled study of the efficacy of the new clinical protocol for outpatients.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/Females, ages 21-
- •Opiate dependence according to DSM-IV criteria. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.
排除标准
- •psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependent on etoh or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
研究组 & 干预措施
buprenorphine
Active Comparator
depot buprenorphine
干预措施: Buprenorphine (Drug)
buprenorphine and ultra-low dose naloxone
Experimental
depot buprenorphine and naloxone
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Opiate withdrawal symptoms
时间窗: 10 test days
opiate withdrawal symptoms are documented for each test day
Opiate craving
时间窗: 10 test days
opiate craving is measured on each test day.
次要结局
未报告次要终点
研究者
Walter Ling
PI
University of California, Los Angeles
研究点 (1)
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