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临床试验/NCT01422837
NCT01422837已完成不适用

VIvitrol's Cost and Treatment Outcomes RegistrY

Alkermes, Inc.30 个研究点 分布在 1 个国家目标入组 403 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
403
试验地点
30

研究概览

简要总结

The objective of the VIVITROL Registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.

详细描述

The VIVITROL Registry is an observational, open-label, single-arm, multi-center registry of patients who have initiated treatment with VIVITROL for prevention of relapse to opioid dependence, following opioid detoxification.

The objectives of the VIVITROL Registry are:

  • To describe characteristics of patients receiving VIVITROL for opioid dependence in real-world clinical practice.
  • To assess clinical, health economic, and health-related quality of life (HRQOL) outcomes in a broad population of patients receiving VIVITROL in real-world clinical practice.
  • To provide additional data to inform future research on VIVITROL.

Patients 18 years of age or older who have been determined by their participating prescriber to be an appropriate candidate for VIVITROL treatment may be offered enrollment into the registry. The decision to treat a patient with VIVITROL will be made by the patient's participating prescriber independent of the registry. VIVITROL will not be provided to patients enrolled in the registry in exchange for their participation; patients will receive commercially available VIVITROL via a standard prescription that will be filled through standard commercial channels.

Patients will be observed while receiving VIVITROL and for six months after they discontinue VIVITROL use. The registry is non-interventional; it will neither direct the treatment plan for enrolled patients nor define the frequency of follow-up visits of each patient. A patient's participation in the registry will not influence or direct patient treatment procedures or follow-up care. It is expected that patients will be seen at least once per month during active VIVITROL treatment to receive their monthly injection.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patient is aged 18 years or older
  • Patient is diagnosed with a current opioid dependence for which treatment with VIVITROL is being initiated
  • Patient has provided written informed consent
  • Patient is willing and able to provide the information to be collected via the registry's interviews and questionnaires
  • Patient expects to be available for ongoing registry participation

排除标准

  • Prior use of VIVITROL

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (30)

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