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Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

Primary Purpose

Alcohol Consumption

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vivitrol (Medication Therapy)
Medication Management Therapy
Sponsored by
Pacific Institute for Research and Evaluation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Consumption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behavioral Health Research Center of the Southwest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vivitrol

Arm Description

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

Outcomes

Primary Outcome Measures

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.
% Days w/1+Interlock Test Failures
This describes the percent of days in past month where the subject at least 1 interlock test failure.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2007
Last Updated
August 23, 2012
Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00537745
Brief Title
Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders
Official Title
Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific Institute for Research and Evaluation
Collaborators
Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivitrol
Arm Type
Experimental
Arm Description
Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Intervention Type
Drug
Intervention Name(s)
Vivitrol (Medication Therapy)
Intervention Description
Vivitrol 380 mg/monthly
Intervention Type
Other
Intervention Name(s)
Medication Management Therapy
Intervention Description
Medication Management Therapy once a month.
Primary Outcome Measure Information:
Title
Evidence of Attempts to Drive After Drinking
Description
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.
Time Frame
6 months
Title
% Days w/1+Interlock Test Failures
Description
This describes the percent of days in past month where the subject at least 1 interlock test failure.
Time Frame
One month post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Lapham, MD, MPH
Organizational Affiliation
Pacific Institute for Research and Evaluation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Behavioral Health Research Center of the Southwest
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States

12. IPD Sharing Statement

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Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

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