临床试验/NCT00000329

NCT00000329撤回2 期

Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment II-1

University of Colorado, Denver2 个研究点分布在 1 个国家开始时间: 1999年4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: Drug/Money Preferences

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 assess the abuse liability and examine the reinforcing effects of intravenous buprenorphine and buprenorphine/naloxone combinations in buprenorphine-naloxone maintained volunteers

详细描述

Ongoing study - results not available at this time

研究设计

研究类型: Interventional
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 yrs 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 and have a history of IV opioid use.

排除标准

•Individuals with evidence of anti 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

Drug/Money Preferences

Subjective dose estimate

Observed withdrawal rating

Opioid agonist rating

Opioid antagonist rating

Analog rating scale for drug effects

Pupil diameter

Drug effect characteristics

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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