临床试验/NCT00032929

NCT00032929已完成3 期

Double-Blind, Placebo-Controlled Trial of Selegiline Transdermal System for the Treatment of Cocaine Dependence

National Institute on Drug Abuse (NIDA)16 个研究点分布在 1 个国家目标入组 269 人开始时间: 2001年3月1日最近更新: 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: 269
试验地点: 16
主要终点: Weekly mean proportion of cocaine non-use days

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 the Selegiline Transdermal System for the treatment of cocaine dependence.

详细描述

The study objectives are to assess the efficacy and safety of the Selegiline Transdermal System (STS) in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that selegiline treatment compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male/Female
•At least 18 years of age
•DSM-4 diagnosis of cocaine dependence
•Ability to understand and provide written consent
•Female subjects must use acceptable birth control

排除标准

•- Additional Criteria available during the screening process at the site.

结局指标

主要结局

Weekly mean proportion of cocaine non-use days

Measured reductions in cocaine and other drug use

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 (16)

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