Alcohol ConsumptionPhase 4NCT00537745
Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders
A Phase 4 study testing Vivitrol (Medication Therapy) and Medication Management Therapy in people with Alcohol Consumption, run by Pacific Institute for Research and Evaluation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Vivitrol (Medication Therapy) and Medication Management Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Health Research Center of the Southwest
Albuquerque, New Mexico, 87102
About this study
Official title: Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study
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.
Read the 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.
- Conditions
- Alcohol Consumption
- Being tested
- Vivitrol (Medication Therapy), Medication Management Therapy
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivitrol (Medication Therapy)Drug
Vivitrol 380 mg/monthly
Medication Management TherapyOther
Medication Management Therapy once a month.
| Study group | Role | What they receive |
|---|---|---|
| Vivitrol | Experimental | Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy). Receives: Drug: Vivitrol (Medication Therapy); Other: Medication Management Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One month post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Principal investigator, Sandra Lapham, Pacific Institute for Research and Evaluation
- Investigators
- Sandra Lapham, MD, MPH, Principal investigator, Pacific Institute for Research and Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537745
- Sponsor's protocol ID
- C18816/6075/DP/US
- Other IDs
- 0328.01.01
- Status last verified
- Aug 2012
- First submitted
- 28 Sep 2007
- Last updated
- 27 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders-a Pilot Study
- ClinicalTrials.gov ID
- NCT00537745
- Acronym / sponsor ID
- C18816/6075/DP/US
- Conditions
- Alcohol Consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Apr 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 1 Oct 2007 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivitrol | Experimental | Drug: Vivitrol (Medication Therapy), Other: Medication Management TherapyVivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivitrol (Medication Therapy)Vivitrol 380 mg/monthly | Drug | Vivitrol |
| Medication Management TherapyMedication Management Therapy once a month. | Other | Vivitrol |
Primary outcome
Evidence of Attempts to Drive After Drinking
Time frame: 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
Time frame: One month post treatment
This describes the percent of days in past month where the subject at least 1 interlock test failure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra Lapham, MD, MPH principal investigator
Pacific Institute for Research and Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vivitrol (Medication Therapy) and Medication Management Therapy in people with Alcohol Consumption, run by Pacific Institute for Research and Evaluation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Attempts to Drive After Drinking (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.