Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Sandra Lapham, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT00537745
First received: September 28, 2007
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Alcohol Consumption
Drug: Vivitrol (Medication Therapy)
Other: Medication Management Therapy
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study

Resource links provided by NLM:


Further study details as provided by Pacific Institute for Research and Evaluation:

Primary Outcome Measures:
  • Evidence of Attempts to Drive After Drinking [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    This describes the percent of days in past month where the subject at least 1 interlock test failure.


Enrollment: 14
Study Start Date: April 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537745

Locations
United States, New Mexico
Behavioral Health Research Center of the Southwest
Albuquerque, New Mexico, United States, 87102
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Cephalon
Investigators
Principal Investigator: Sandra Lapham, MD, MPH Pacific Institute for Research and Evaluation
  More Information

No publications provided

Responsible Party: Sandra Lapham, Center Director, Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT00537745     History of Changes
Other Study ID Numbers: C18816/6075/DP/US, 0328.01.01
Study First Received: September 28, 2007
Results First Received: July 20, 2011
Last Updated: August 23, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014