Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

Phase 4

Completed

• Conditions: Alcohol Consumption
• Interventions: Drug: Vivitrol (Medication Therapy); Other: Medication Management Therapy

• Registration Number: NCT00537745
• Lead Sponsor: Pacific Institute for Research and Evaluation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-09-30
• Study First Posted: 2007-10-01
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2011-07-20
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-23
• Last Update Submitted: 2012-08-23
• Results First Posted: 2012-08-27
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evidence of Attempts to Drive After Drinking	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	One month post treatment	This describes the percent of days in past month where the subject at least 1 interlock test failure.

Trial Locations

Locations (1)

Behavioral Health Research Center of the Southwest; 🇺🇸 Albuquerque, New Mexico, United States