Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vivitrol
Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
干预措施: Vivitrol (Medication Therapy) (Drug)
Vivitrol
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
Sandra Lapham
Center Director
Pacific Institute for Research and Evaluation
