临床试验/NCT00032942

NCT00032942已完成3 期

A Phase III Placebo-Controlled, Double-Blind Multi-Site Trial of Lofexidine for Opiate Withdrawal

National Institute on Drug Abuse (NIDA)5 个研究点分布在 1 个国家目标入组 66 人开始时间: 2001年4月最近更新: 2017年1月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: National Institute on Drug Abuse (NIDA)
入组人数: 66
试验地点: 5
主要终点: Opiate withdrawal symptoms

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate lofexidine for opiate withdrawal.

详细描述

An 11 day inpatient placebo-controlled, double-blind study of 96 opiate dependent, treatment seeking individuals randomized to 2 medication groups: lofexidine and placebo to be conducted in inpatient units at 3 treatment sites.

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 99 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female as least 18 yrs of age & above with a current dependence on heroin, morphine or hydromorphone according to DSM4 criteria; subject ; voluntarily given consent and signed informed consent; females using appropriate birth control method.

排除标准

•Additional criteria available during screening at the site

结局指标

主要结局

Opiate withdrawal symptoms

Potential Abuse Liability

次要结局

未报告次要终点

研究者

发起方

National Institute on Drug Abuse (NIDA)

申办方类型

Nih

研究点 (5)

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