Trial Outcomes & Findings for Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders (NCT NCT00537745)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

6 months

Results posted on

2012-08-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Vivitrol Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Overall Study STARTED	14
Overall Study Began Intervention	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Vivitrol Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Overall Study Did not meet eligibility criteria	2
Overall Study Withdrawal by Subject	2
Overall Study Subject unable to provide Interlock info	1

Baseline Characteristics

Vivitrol for Reducing Driving While Impaired Behavior Among Repeat Offenders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vivitrol n=14 Participants Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Age Continuous	43.14 years STANDARD_DEVIATION 11.08 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants
Average Drinks/day	3.0 Standard Drinks STANDARD_DEVIATION 1.8 • n=93 Participants
% days w/1+Interlock test failures	3.1 percent of days STANDARD_DEVIATION 4.4 • n=93 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants n=1000 Percent of Days Intervention Group
Evidence of Attempts to Drive After Drinking Percent Days Interlock Fail Pre/on Medication	-1.29 percent of days Interval -6.41 to 2.16
Evidence of Attempts to Drive After Drinking Percent Days Interlock Fail Post Medication	-0.30 percent of days Interval -3.23 to 2.13

PRIMARY outcome

Timeframe: 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.

This describes the percent of days in past month where the subject at least 1 interlock test failure.

Outcome measures

Outcome measures
Measure	Participants n=10 Participants Intervention Group
% Days w/1+Interlock Test Failures	-.30 percent of days Interval -3.23 to 2.13

Adverse Events

Vivitrol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vivitrol n=12 participants at risk Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
Skin and subcutaneous tissue disorders Induration at Injection site	10.0% 1/10 • Number of events 1
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 2

Additional Information

Patricia Hokanson

PIRE

Phone: 505-765-2325

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place