A Phase 4 interventional study of Vivitrol (Medication Therapy) and Medication Management Therapy in Alcohol Consumption, sponsored by Pacific Institute for Research and Evaluation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-27.
Sponsored by Pacific Institute for Research and Evaluation · Phase 4, Interventional, and Treatment
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.
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.
940 studies on the registry are indexed under Alcohol Drinking; 169 are open to participants now.
This study's enrollment of 14 is below the median of 108 across 813 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Pacific Institute for Research and Evaluation is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria
Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Drug: Vivitrol (Medication Therapy) · Other: Medication Management Therapy
Vivitrol 380 mg/monthly
Medication Management Therapy once a month.
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
% 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
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.
| Milestone | Vivitrol |
|---|---|
| Started | 14 |
| Began intervention | 11 |
| Completed | 9 |
| Not completed | 5 |
| Withdrew: Did not meet eligibility criteria | 2 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Subject unable to provide interlock info | 1 |
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.
| percent of days | Participants |
|---|---|
| Percent Days Interlock Fail Pre/on Medication | -1.29 (-6.41 to 2.16) |
| Percent Days Interlock Fail Post Medication | -0.30 (-3.23 to 2.13) |
This describes the percent of days in past month where the subject at least 1 interlock test failure.
| percent of days | Vivitrol |
|---|---|
| % Days w/1+Interlock Test Failures | -.30 (-3.23 to 2.13) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vivitrol | — | 0/12 (0%) | 1/12 (8.3%) |
| Event | Vivitrol |
|---|---|
| Induration at Injection siteSkin and subcutaneous tissue disorders | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| Age Continuous(years) | Vivitrol |
|---|---|
| Mean | 43.14 ± 11.08 |
| Sex: Female, Male(Participants) | Vivitrol |
|---|---|
| Female | 7 |
| Male | 7 |
| Average Drinks/day(Standard Drinks) | Vivitrol |
|---|---|
| Mean | 3.0 ± 1.8 |
| % days w/1+Interlock test failures(percent of days) | Vivitrol |
|---|---|
| Mean | 3.1 ± 4.4 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vivitrol
Pacific Institute for Research and Evaluation