Status:
COMPLETED
A Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
Lead Sponsor:
Alkermes, Inc.
Conditions:
Opioid Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01453374
Start Date
January 1 2011
End Date
May 1 2014
Last Update
July 13 2015
Active Locations (1)
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1
Friends Research Institute
Baltimore, Maryland, United States, 21201