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: March 8, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Opiate Dependence
Drug: Extended-Release Naltrexone
Behavioral: Motivational Enhancement Counseling
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Post-Release Opioid Relapse [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    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:
  • Participation in Community Drug Treatment Post-release [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    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.

  • Any Opioid Use Post-release [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    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.

  • Injection Drug Use Post-release [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
    This secondary outcome tracks any injection drug use and frequency of injection drug use 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.


Enrollment: 48
Study Start Date: May 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
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: 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

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 
Study First Received: August 10, 2010
Results First Received: April 13, 2015
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2016