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

Alkermes

Status and phase: Completed; Phase 4

Conditions: Opioid Dependence

Treatments: Drug: VIVITROL 380mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01453374

ALK21-028

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

27 participants in 1 patient group

VIVITROL

Experimental group

Description:

380 mg IM injection

Treatment:

Drug: VIVITROL 380mg