NCT00829777已完成1 期
A Phase-I, Two-Stage, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Trial of Low Doses of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- - 6β-Naltrexol will have 13 hr half-life. Plasma collected
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of intravenous 6β-Naltrexol administered to opiate dependent subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opiate dependent males and females age 21-45 on stable doses of methadone
- •Fluent English speaker
- •Willing and able to give written consent
排除标准
- •Pregnancy or lactation
- •FOR MORE DETAILS CONTACT THE RESEARCH CLINIC.
结局指标
主要结局
- 6β-Naltrexol will have 13 hr half-life. Plasma collected
时间窗: -0-24 hrs post dose
- 6β-Naltrexol pharmacokinetic profile in opioid-dependent population will be similar in non-opioid-dependent population. Plasma levels collected
时间窗: 0-8 hrs post dose
次要结局
- -6β-Naltrexol will have a lower potency in precipitating withdrawal and be better tolerated than Naloxone assessed by vital signs, objective/subjective ate Withdrawal Scales, Visual Analog Scales, Pupil Size and GI Motility measures(0-8 hrs post dose)
- 6β-Naltrexol dose-dependent increases to reverse methadone-induced bowel dysfunction. Plasma levels and Hydrogen Breath Tests(0-8 hrs post dose)
研究者
研究点 (2)
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