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

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ClinicalTrials.gov Identifier: NCT01180647
Recruitment Status : Completed
First Posted : August 12, 2010
Results First Posted : April 7, 2016
Last Update Posted : April 7, 2016
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

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Opiate Dependence Drug: Extended-Release Naltrexone Behavioral: Motivational Enhancement Counseling Phase 3

Detailed Description:
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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail
Study Start Date : May 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Post-Release Opioid Relapse [ Time Frame: Four weeks post-release ]
    Post-release opioid relapse at week 4, measured by self-report (Time Line Follow Back) and urine toxicologies, and defined as ≥10 of 28 days of self-reported opioid misuse following jail release or two or three positive of the three urine samples during weeks 2, 3 and 4. A single positive or missing urine result counted as 7 opioid misuse days.


Secondary Outcome Measures :
  1. Participation in Community Drug Treatment Post-release [ Time Frame: Four weeks post-release ]
    This secondary outcome tracks community drug treatment initiation four weeks post-release from jail. Measured by self-report community drug treatment initiation at week 4 study visit.

  2. Any Opioid Use Post-release [ Time Frame: Four weeks post-release ]
    Counts of any opioid use, defined as self-reported ≥ 1 day of heroin or other opioid use as measured by the Timeline Follow-Back assessment during the first 4 weeks post-release.

  3. Injection Drug Use Post-release [ Time Frame: Four weeks post-release ]
    This secondary outcome tracks any injection drug use and frequency of injection drug use in the four weeks following release from jail.

  4. Accidental Drug Overdose [ Time Frame: Four weeks post-release ]
    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.

  5. Adverse Events and Serious Adverse Events [ Time Frame: Eight weeks post-release ]
    AEs and SAEs per standard definitions will be measured by self-report.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01180647


Locations
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
New York City Department of Correction
New York, New York, United States, 11370
Sponsors and Collaborators
New York University School of Medicine
Alkermes, Inc.
New York City Department of Health and Mental Hygiene
Investigators
Principal Investigator: Joshua D Lee, MD MSc NYU School of Medicine
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Joshua D. Lee, Assistant Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01180647     History of Changes
Other Study ID Numbers: NYU IRB Number: 09-0372
First Posted: August 12, 2010    Key Record Dates
Results First Posted: April 7, 2016
Last Update Posted: April 7, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Joshua D. Lee, New York University School of Medicine:
Extended-release naltrexone
Prisoners
Opioid addiction prevention
Medication Treatment Alternatives
Prevention of Relapse to Opioid Addiction

Additional relevant MeSH terms:
Recurrence
Opioid-Related Disorders
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
 Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists