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Completed

NCT Number: NCT01453374

A 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.

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Friends Research Institute

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VIVITROL 380mg

Drug

380 mg IM injection given once monthly

Primary outcomes

  1. Incidence of Subject Re-arrest

    Time frame: 7 months

    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 outcomes

  1. Incidence of Subject Re-incarceration

    Time frame: 7 months

    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.

  2. Opioid Use

    Time frame: 7 months

    Opioid use was obtained via self-report on the Addiction Severity Index (ASI) or via a urine drug test.

  3. Opioid Overdose

    Time frame: 7 months

    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.

  4. Drug Abuse Treatment Program Entry

    Time frame: 7 months

    Number of subjects who participated in a drug treatment program during the study; assessed by review of Treatment Services Form.

  5. Retention in the Community

    Time frame: 6 months

    Number of subjects who received all 6 post-release VIVITROL injections

  6. Opioid Craving

    Time frame: 8 months

    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.

  7. Opioid Dependence

    Time frame: 7 months

    Meeting Diagnostic Statistical Manual, version IV, text revision (DSM-IV-TR) criteria for opioid dependence

  8. Cocaine Use

    Time frame: 6 months

    Number of subjects who used cocaine during the study; assessed using the Addiction Severity Index (ASI) and urine drug tests

  9. Criminal Activity

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 17, 2011
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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