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临床试验/NCT00537745
NCT00537745已完成4 期

Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study

Pacific Institute for Research and Evaluation1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
14
试验地点
1
主要终点
Evidence of Attempts to Drive After Drinking

研究概览

简要总结

The purpose of this study is to determine whether Vivitrol is effective at reducing attempts to drive after drinking among repeat driving while intoxicated (DWI) offenders with Ignition Interlock devices.

详细描述

We propose to conduct an open label trial of Vivitrol in combination with an individual compliance enhancement therapy known as Medication Management Therapy (MMT) as an adjunct to Ignition Interlock in the management and treatment of DWI. Subjects will be recruited from a local Interlock provider. This program of research will collect pilot data for a study to determine whether pharmacotherapy, previously recognized as effective, can be successfully combined with existing counseling treatments and sanctions for persons convicted of a repeat DWI alcohol offense. We will investigate the extent to which this combination of sanctions and treatment will significantly decrease attempts to drive after drinking among offenders, and whether the effect persists following discontinuation of Vivitrol.

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Vivitrol

Experimental

Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).

干预措施: Vivitrol (Medication Therapy) (Drug)

Vivitrol

Experimental

Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).

干预措施: Medication Management Therapy (Other)

结局指标

主要结局

Evidence of Attempts to Drive After Drinking

时间窗: 6 months

This was measured as Percent of days with an Interlock report of "Failure to Start" due to alcohol pre/on medication and 6 months post medication.

% Days w/1+Interlock Test Failures

时间窗: One month post treatment

This describes the percent of days in past month where the subject at least 1 interlock test failure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandra Lapham

Center Director

Pacific Institute for Research and Evaluation

研究点 (1)

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