Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

Pacific Institute for Research and Evaluation (PIRE)

Status and phase

Completed

Phase 4

Conditions

Alcohol Consumption

Treatments

Drug: Vivitrol (Medication Therapy)

Other: Medication Management Therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00537745

C18816/6075/DP/US

0328.01.01

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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