A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

Study Overview
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Brief Summary
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This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

Detailed Description
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This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.

Official Title
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A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

Conditions
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Opioid Dependence

Intervention / Treatment
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* Drug: VIVITROL 380mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening Expressing a goal of opiate-free treatment upon release Currently opioid free Planning to live in the Baltimore, MD area for at least 8 months following prison release Exclusion Criteria: Pregnancy and/or breastfeeding Clinically significant active medical condition Active hepatitis Past or present history of an AIDS-indicator disease in subjects who are infected with HIV Any untreated or unstable psychiatric disorder(eg, bipolar with mania) Recent suicidal ideation Current chronic pain diagnosis for which opioids are prescribed Positive drug test for opioids History of drug overdose within the past 3 years requiring inpatient hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIVITROL<br>380 mg IM injection | Drug: VIVITROL 380mg<br>* 380 mg IM injection given once monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Subject Re-arrest | Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Subject Re-incarceration | Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report. | 7 months | 
| Opioid Use | Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test. | 7 months | 
| Opioid Overdose | Number of subjects who overdosed during the study; measured through reported AEs of overdose and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times. | 7 months | 
| Drug Abuse Treatment Program Entry | Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form. | 7 months | 
| Retention in the Community | Number of subjects who received all 6 post-release VIVITROL injections | 6 months | 
| Opioid Craving | Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever. | 8 months | 
| Opioid Dependence | Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence | 7 months | 
| Cocaine Use | Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests | 6 months | 
| Criminal Activity | Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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criminal justice, opioid dependence, VIVITROL