Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Consumption
• Intervention / Treatment: Drug: Vivitrol (Medication Therapy); Other: Medication Management Therapy

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Behavioral Health Research Center of the Southwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Age ≥ 18
• Capable of understanding and complying with the protocol, and has signed the informed consent document
• Been convicted of a DWI offense, have at least one additional arrest for DWI, and be entering an ignition interlock program
• They must be able to participate in a 6 month outpatient study; and reside within a one-hour commute to the research site
• Women of childbearing potential must have a negative pregnancy test, use contraceptive methods, and not be breastfeeding
• Negative urine toxicological screen for opiates at screening and randomization
• Has a non-custodial stable residence and telephone

Exclusion Criteria

• Is pregnant and/or currently breastfeeding
• Has a clinically significant medical condition or observed abnormality that is contraindicated for Vivitrol treatment
• Is taking an excluded medication, including but not limited to benzodiazepines, anticonvulsants, opiates, or alcohol treatment medication
• Not stable on current anti-depressant, as evidenced by less than 3 months at current dosage, plans to discontinue, or plans to change the dosage
• Has been hospitalized for medical detoxification within 30 days of screening
• Has evidence of severe kidney, heart, or lung disease
• Has evidence of severe hepatic disease (as evidence by BUN > 10% above ULN, AST, ALT > 3x ULN, and GGT > 5x ULN at randomization)
• Known or suspected hypersensitivity to naltrexone and/or Vivitrol in particular
• Current diagnosis and symptoms of major depression, anxiety disorder, mania or psychosis (subjects with their illness in remission for 3 months may be included)
• Opioid use within the past 14 days and/or current or recent (within the past year) diagnosis of dependence or abuse of opiates, benzodiazepines, or cocaine.
• Current or anticipated need for prescribed opiate medication during the study period
• Medication with naltrexone, disulfiram, acamprosate or other medication used to treat alcoholism within the past 30 days
• Impending incarceration or other known situation that would preclude participation in the study
• Other non-alcohol Axis I substance dependence diagnosis in the past 12 months, excluding nicotine, marijuana, and caffeine
• Has participated in a clinical trial of a pharmacological agent within 30 days of screening
• Has any finding that in the view of the principal investigator would compromise the subject's ability to fulfill the protocol visit schedule, and/or visit requirements or would affect subject safety during participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vivitrol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Attempts to Drive After Drinking	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.	6 months
% Days w/1+Interlock Test Failures	This describes the percent of days in past month where the subject at least 1 interlock test failure.	One month post treatment

Collaborators and Investigators

• Sponsor: Pacific Institute for Research and Evaluation
• Collaborators: Cephalon
• Investigators: Principal Investigator: Sandra Lapham, MD, MPH, Pacific Institute for Research and Evaluation

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 28, 2007
• First Submitted That Met QC Criteria: September 30, 2007
• First Posted (Estimate): October 1, 2007

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 23, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: C18816/6075/DP/US; 0328.01.01