Extended-Release Naltrexone Opiod Treatment at Jail Re-Entry (XOR)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by New York University School of Medicine
Sponsor:
Collaborators:
Friends Research Institute, Inc.
University of California, Los Angeles
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01999946
First received: November 26, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.


Condition Intervention Phase
Heroin Dependence
Opioid-Related Disorders
Drug: Extended-Release Naltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended-Release Naltrexone Opiod Treatment at Jail Re-Entry

Resource links provided by NLM:


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

Primary Outcome Measures:
  • DSM-5 Opioid Use Disorder Diagnosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    DSM-5 Opioid Use Disorder Diagnosis measured at the 6-month follow-up visits (post-release). This will be measured using the CIDI DSM-V.


Secondary Outcome Measures:
  • HIV risk behavior [ Time Frame: Baseline, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    HIV risk behavior will be assessed using the HIV-GAIN assessment at 1, 3, 6 and 12 months.

  • Number of days incarcerated [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Number of days incarcerated at 1, 3, 6 and 12 months post-release will be measured by use of self-report, NYC DOC "Inmate Locator" source reports obtained online, and by using a modified Economic Form 90.

  • Non-opioid drug use (Cocaine, Alcohol, Benzodiazepines, IV Drug Use) [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Non-opioid drug use, including cocaine, alcohol, benzodiazepines, IV drug use will be assessed at 1, 3, 6 and 12 months.

  • Days in drug abuse treatment [ Time Frame: 1, 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Days in drug abuse treatment, including any inpatient, outpatient, substance abuse counseling, or 12-step recovery group meetings will be assessed at 1, 3, 6 and 12 months by self-report (Economic Form 90).

  • Number of arrests [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Number of arrests will be assessed at 1, 3, 6, and 12 months post-release using a combination of self-report, NYC DOC "Inmate Locator" information obtained online, and a modified Economic Form 90.

  • Craving [ Time Frame: Baseline, 1, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Craving scale measurements (opiates, alcohol, nicotine, and other drugs) will be assessed using the Visual Analog Scale at baseline, 1, 3, 6, and 12 months.

  • Overdose [ Time Frame: 1, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Any drug overdose will be assessed by a self-report measure at 1, 3, 6, and 12 months post-release.

  • Motivation for Treatment [ Time Frame: Baseline, 3, 6, and 12 months ] [ Designated as safety issue: No ]
    Motivation to discontinue drug use and to participate in substance abuse treatment will be assessed using an adapted motivation scale and assessed at baseline, 3, 6, and 12 months.


Estimated Enrollment: 255
Study Start Date: December 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Extended-Release Naltrexone
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Drug: Extended-Release Naltrexone
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Other Names:
  • Vivitrol
  • XR-NTX
No Intervention: Enhanced Treatment As Usual
Enhanced Treatment As Usual arm will not receive any study medication, but 2-session enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment, including agonist maintenance (methadone and buprenorphine programs), drug-free outpatient and 12-step resources, and residential treatment including supportive housing programs will be provided. These counseling and referral efforts are designed to exceed standard, out-of-treatment experiences, and will ensure both arms are offered tangible health benefits above and beyond that of the usual jail incarceration period in accordance with DHS prisoner research standards.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults incarcerated in NYC jails with known release dates.
  • DSM-IV criteria for current opioid dependence.
  • Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.
  • Currently opioid free by history ('detoxed') and with a negative urine for all opioids.
  • General good health as determined by complete medical history and physical examination
  • Age >18 years.

Exclusion Criteria:

  • History of liver failure and/or liver function test levels greater than three times normal.
  • Pregnancy, lactation, or planning conception.
  • Active medical illness that might make participation hazardous.
  • Untreated or poorly controlled psychiatric disorder precluding safe participation --History of allergic reaction to naltrexone.
  • 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: NCT01999946

Contacts
Contact: Ryan D McDonald, MA 646-501-2541 ryan.mcdonald@nyumc.org
Contact: Joshua D Lee, MD MS 212-263-4242 joshua.lee@nyumc.org

Locations
United States, New York
Bellevue Hospital Center Not yet recruiting
New York, New York, United States, 10016
Contact: Nadina Santana-Correa       nadina.santana-correa@nyumc.org   
NYC Department of Corrections: Rikers Island Jail Facilities Not yet recruiting
New York, New York, United States, 11370
Sponsors and Collaborators
New York University School of Medicine
Friends Research Institute, Inc.
University of California, Los Angeles
Investigators
Principal Investigator: Joshua D Lee, MD MS NYU MEDICAL CENTER
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01999946     History of Changes
Other Study ID Numbers: S12-03724, 1U01DA033336-01A1
Study First Received: November 26, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
Heroin Dependence
Opioid-Related Disorders

Additional relevant MeSH terms:
Heroin Dependence
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 October 20, 2014