NCT01453374

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
DRUG	VIVITROL 380mg	380 mg IM injection given once monthly

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-10-17
• Last updated: 2015-07-13
• Results posted: 2015-07-13

Locations

1 site across 1 country: United States