临床试验/NCT00000328

NCT00000328撤回2 期

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III

University of Colorado, Denver2 个研究点分布在 1 个国家开始时间: 1997年7月最近更新: 2017年5月4日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方: University of Colorado, Denver
试验地点: 2
主要终点: Opioid agonist rating

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 compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

详细描述

S/A brief "Summary for the Public"

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

入选标准

•Individuals must be at least 18 years of age, currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

排除标准

•Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.

结局指标

主要结局

Opioid agonist rating

Opioid antagonist rating

Compliance

Addiction Severity Index (ASI) Composite Score Rating

Drug use

Retention

Medication identification

次要结局

未报告次要终点

研究者

发起方

University of Colorado, Denver

申办方类型

Other

责任方

Sponsor

研究点 (2)

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