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

Alkermes, Inc.27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid Dependence

Interventions

VIVITROL 380mgDRUG

380 mg IM injection given once monthly

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Friends Research Institute

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 7 months

Secondary Outcomes

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.

Time frame: 7 months

Opioid Use

Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.

Time frame: 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.

Time frame: 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.

Time frame: 7 months

Retention in the Community

Number of subjects who received all 6 post-release VIVITROL injections

Time frame: 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.

Data from ClinicalTrials.gov

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