Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders
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|ClinicalTrials.gov Identifier: NCT00537745|
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : August 27, 2012
Last Update Posted : August 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Consumption||Drug: Vivitrol (Medication Therapy) Other: Medication Management Therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||May 2009|
Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Drug: Vivitrol (Medication Therapy)
Vivitrol 380 mg/monthly
Other: Medication Management Therapy
Medication Management Therapy once a month.
- Evidence of Attempts to Drive After Drinking [ Time Frame: 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 [ Time Frame: One month post treatment ]This describes the percent of days in past month where the subject at least 1 interlock test failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537745
|United States, New Mexico|
|Behavioral Health Research Center of the Southwest|
|Albuquerque, New Mexico, United States, 87102|
|Principal Investigator:||Sandra Lapham, MD, MPH||Pacific Institute for Research and Evaluation|