Alcohol Consumption
Conditions
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.
Interventions
DRUGVivitrol (Medication Therapy)
Vivitrol 380 mg/monthly
OTHERMedication Management Therapy
Medication Management Therapy once a month.
Sponsors
Cephalon
Pacific Institute for Research and Evaluation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Attempts to Drive After Drinking | 6 months | 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 | One month post treatment | This describes the percent of days in past month where the subject at least 1 interlock test failure. |
Countries
United States
Participant flow
Recruitment details
Subjects were initially recruited from only two local Ignition Interlock providers. Recruitment was expanded by placing advertisements in local free press venues and flyers at all local Ignition Interlock providers.
Participants by arm
| Arm | Count |
|---|---|
| Vivitrol Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy). | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet eligibility criteria | 2 |
| Overall Study | Subject unable to provide Interlock info | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Vivitrol |
|---|---|
| Age Continuous | 43.14 years STANDARD_DEVIATION 11.08 |
| Average Drinks/day | 3.0 Standard Drinks STANDARD_DEVIATION 1.8 |
| % days w/1+Interlock test failures | 3.1 percent of days STANDARD_DEVIATION 4.4 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
% Days w/1+Interlock Test Failures
This describes the percent of days in past month where the subject at least 1 interlock test failure.
Time frame: One month post treatment
Population: Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Participants | % Days w/1+Interlock Test Failures | -.30 percent of days |
Primary
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.
Time frame: 6 months
Population: Twelve subjects were consented. One was dropped because of no interlock device. Another subject completed Visit 1 and then decided she did not want to receive any injections. Of the ten remaining subjects, seven received all 3, one received 2, and two received only 1, injection. These 10 subjects were used in the intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Participants | Evidence of Attempts to Drive After Drinking | Percent Days Interlock Fail Pre/on Medication | -1.29 percent of days |
| Participants | Evidence of Attempts to Drive After Drinking | Percent Days Interlock Fail Post Medication | -0.30 percent of days |