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

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

Study Overview

• Status: Completed
• Conditions: Opioid Dependence
• Intervention / Treatment: Drug: VIVITROL 380mg

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Friends Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIVITROL; 380 mg IM injection	Drug: VIVITROL 380mg; 380 mg IM injection given once monthly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Subject Re-arrest	Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Subject Re-incarceration	Subjects were considered to have had a re-incarceration, a sentence to jail and/or prison, if the subject had re-incarceration records in the official criminal justice records and/or via self-report.	7 months
Opioid Use	Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.	7 months
Opioid Overdose	Number of subjects who overdosed during the study; measured through reported AEs of "overdose" and Opiate Overdose Form. The Form asks subjects if subjects overdosed during the past 30 days and, if so, how many times.	7 months
Drug Abuse Treatment Program Entry	Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.	7 months
Retention in the Community	Number of subjects who received all 6 post-release VIVITROL injections	6 months
Opioid Craving	Change from baseline in peak craving score 30 days post last injection; assessed using a 100 mm visual analog scale (VAS). Subjects are asked to make 1 slash mark through a point on a 100 mm line that best describes their greatest craving for opioids, whereby 0 represents no craving and 100 is more than ever.	8 months
Opioid Dependence	Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence	7 months
Cocaine Use	Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests	6 months
Criminal Activity	Number of subjects who conducted any criminal activity during the study; assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires	6 months

Collaborators and Investigators

• Sponsor: Alkermes, Inc.
• Investigators: Study Director: Bernard L Silverman, MD, Alkermes, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 13, 2011
• First Posted (Estimate): October 17, 2011

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: opioid dependence; criminal justice; VIVITROL
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: ALK21-028