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

Completed · Phase 4

Conditions studied: Opioid Dependence

In brief

This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.

Key facts

Study ID

NCT01453374

Run by

Alkermes, Inc.

People needed

27

Starts

2011-01-01

Expected to finish

2014-05-01

Last updated by the study team

2015-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Friends Research Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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