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Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

This study has been completed.
Sponsor:
Collaborators:
Alkermes, Inc.
New York City Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Joshua D. Lee, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01180647
First received: August 10, 2010
Last updated: July 22, 2013
Last verified: July 2013

August 10, 2010
July 22, 2013
May 2010
July 2013   (final data collection date for primary outcome measure)
Opioid Relapse [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
More than ten total days of opioid use in the four weeks following release from jail as tabulated by the Timeline Follow-Back assessment.
Same as current
Complete list of historical versions of study NCT01180647 on ClinicalTrials.gov Archive Site
  • Opioid treatment retention/initiation [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    This secondary outcome tracks other opioid treatment retention and/or initiation during the four weeks post-release.
  • Any opioid use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    Rates of any opioid use, defined as continuous counts of both days and amount/day of heroin or other opioid use as measured by the Timeline Follow-Back assessment.
  • Injection drug use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    This secondary outcome tracks any injection drug use and frequency of IDU in the four weeks following release from jail.
  • Accidental drug overdose [ Time Frame: Four weeks post-release ] [ Designated as safety issue: Yes ]
    Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
  • Adverse Events and Serious Adverse Events [ Time Frame: Eight weeks post-release ] [ Designated as safety issue: Yes ]
    AEs and SAEs per standard definitions will be measured by self-report.
  • Opioid treatment retention/initiation [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    This secondary outcome tracks other opioid treatment retention and/or inititaion during the four weeks post-release.
  • Any opioid use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    Rates of any opioid use, defined as continuous counts of both days and amount/day of heroin or other opioid use as measured by the Timeline Follow-Back assessment.
  • Injection drug use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    This secondary outcome tracks any injection drug use and frequency of IDU in the four weeks following release from jail.
  • Accidental drug overdose [ Time Frame: Four weeks post-release ] [ Designated as safety issue: Yes ]
    Accidental drug overdose is defined as patient self-report of any event consistent with over-sedation or respiratory suppression following ingestion of alcohol, prescription, or illicit drugs.
  • Adverse Events and Serious Adverse Events [ Time Frame: Eight weeks post-release ] [ Designated as safety issue: Yes ]
    AEs and SAEs per standard definitions will be measured by self-report.
Not Provided
Not Provided
 
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Opiate Dependence
  • Drug: Extended-Release Naltrexone
    380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
    Other Name: Vivitrol
  • Behavioral: Motivational Enhancement Counseling
    The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
  • Active Comparator: Extended-release naltrexone (XR-NTX)
    A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
    Intervention: Drug: Extended-Release Naltrexone
  • Placebo Comparator: Motivational Enhancement Counseling Only
    The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
    Intervention: Behavioral: Motivational Enhancement Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults incarcerated in NYC jails with known release date
  • DSM-IV criteria for current opioid dependence
  • No current agonist (methadone, buprenorphine) treatment
  • Currently opioid free by history ('detoxed') and with a negative urine for all opioids
  • General good health as determined by complete medical interview and physical examination
  • Age 18-60 years.

Exclusion Criteria:

  • History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
  • Pregnancy, lactation, or planning conception
  • Active medical illness that might make participation hazardous
  • Untreated psychiatric disorder
  • History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
  • Current chronic pain condition treated with opioids.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180647
NYU IRB Number: 09-0372
Yes
Joshua D. Lee, New York University School of Medicine
New York University School of Medicine
  • Alkermes, Inc.
  • New York City Department of Health and Mental Hygiene
Principal Investigator: Joshua D Lee, MD MSc NYU School of Medicine
New York University School of Medicine
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP