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 |
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
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