Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Intervention: Vivitrol (Medication Therapy); Medication Management Therapy
Intervention description: Vivitrol 380 mg/monthly; Medication Management Therapy once a month.
Intervention MeSH terms: Naltrexone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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