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

Phase 4

Completed

Conditions: Opioid Dependence

Interventions: Drug: VIVITROL 380mg

Registration Number: NCT01453374

Lead Sponsor: Alkermes, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VIVITROL	VIVITROL 380mg	380 mg IM injection

Primary Outcome Measures

Name	Time	Method
Incidence of Subject Re-arrest	7 months	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.

Secondary Outcome Measures

Name	Time	Method
Retention in the Community	6 months	Number of subjects who received all 6 post-release VIVITROL injections
Incidence of Subject Re-incarceration	7 months	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.
Opioid Use	7 months	Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.
Opioid Overdose	7 months	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.
Drug Abuse Treatment Program Entry	7 months	Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.
Opioid Craving	8 months	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.
Opioid Dependence	7 months	Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence
Cocaine Use	6 months	Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests
Criminal Activity	6 months	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