A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Information source: Alkermes, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid Dependence
Intervention: VIVITROL 380mg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alkermes, Inc. Official(s) and/or principal investigator(s): Bernard L Silverman, MD, Study Director, Affiliation: Alkermes, Inc.
Summary
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in
prison and continuing VIVITROL upon release into the community.
Clinical Details
Official title: A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Incidence of Subject Re-arrest
Secondary outcome: Incidence of Subject Re-incarcerationOpioid Use Opioid Overdose Drug Abuse Treatment Program Entry Retention in the Community Opioid Craving Opioid Dependence Cocaine Use Criminal Activity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 and Contacts
Friends Research Institute, Baltimore, Maryland 21201, United States
Additional Information
Starting date: January 2011
Last updated: June 19, 2015
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