Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

NCT00537745 | Completed Phase 4 Results

• 2 other identifiers: C18816/6075/DP/US0328.01.01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Consumption

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Vivitrol

EXPERIMENTAL

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

Drug: Vivitrol (Medication Therapy); Other: Medication Management Therapy

Interventions

Vivitrol (Medication Therapy) DRUG

Vivitrol 380 mg/monthly

Vivitrol

Medication Management Therapy OTHER

Medication Management Therapy once a month.

Vivitrol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Institute for Research and Evaluation: lead
• Cephalon: collaborator

Study Sites (1)

Behavioral Health Research Center of the Southwest

Albuquerque, New Mexico, 87102, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

vivitrol; Drug Therapy; Medication Therapy Management

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Limitations and Caveats

Fourteen subjects were consented, and began the screening process. Two subjects did not meet entry criteria and 1 withdrew consent prior to injection. Of the remaining 11 subjects, 7 received 3, 2 received 2, and 2 received 1 injection(s).

Results Point of Contact

• Title: Patricia Hokanson
• Organization: PIRE

info@bhrcs.org

505-765-2325

Study Officials

• Sandra Lapham, MD, MPH

  Pacific Institute for Research and Evaluation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 27, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-08

Locations

US (1)