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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-incarceration

Opioid 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

Page last updated: August 23, 2015

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