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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT01453374
First received: October 13, 2011
Last updated: June 19, 2015
Last verified: June 2015
  Purpose

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


Condition Intervention Phase
Opioid Dependence
Drug: VIVITROL 380mg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

Primary Outcome Measures:
  • Incidence of Subject Re-arrest [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of Subject Re-incarceration [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.

  • Opioid Use [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.

  • Opioid Overdose [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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.

  • Drug Abuse Treatment Program Entry [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.

  • Retention in the Community [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of subjects who received all 6 post-release VIVITROL injections

  • Opioid Craving [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.

  • Opioid Dependence [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence

  • Cocaine Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests

  • Criminal Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Enrollment: 27
Study Start Date: January 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VIVITROL
380 mg IM injection
Drug: VIVITROL 380mg
380 mg IM injection given once monthly

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453374

Locations
United States, Maryland
Friends Research Institute
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Bernard L Silverman, MD Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT01453374     History of Changes
Other Study ID Numbers: ALK21-028
Study First Received: October 13, 2011
Results First Received: May 21, 2015
Last Updated: June 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes, Inc.:
opioid dependence
VIVITROL
criminal justice

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015