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



Status:Completed
Conditions:Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:January 2011
End Date:August 2013
Contact:Katherine M Santoro
Email:Katie.Santoro@alkermes.com

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


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.

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
We found this trial at
1
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Baltimore, Maryland 21201
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Baltimore, MD
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