NCT00834080已完成3 期
Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Health care professional (eg, physician, osteopath, nurse, pharmacist)
- •18 years of age or older
- •Enrolled or enrolling in an extended outpatient treatment program for opioid dependence
- •Women of childbearing potential must agree to use an approved method of contraception for the duration of the study
排除标准
- •Pregnancy and/or lactation
- •Evidence of hepatic failure
- •Active hepatitis
- •Any psychiatric disorder that would compromise ability to complete study requirements
- •Recent history of suicidal ideation or attempt
- •Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine
- •Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening
研究组 & 干预措施
Medisorb naltrexone 380 mg (VIVITROL)
Experimental
干预措施: Medisorb naltrexone 380 mg (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.
时间窗: 2 years (Baseline to end of study)
A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period).
次要结局
未报告次要终点
研究者
研究点 (1)
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