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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Naltrexone

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