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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by New York University School of Medicine
Sponsor:
Collaborators:
Friends Research Institute, Inc.
University of California, Los Angeles
Information provided by (Responsible Party):
Joshua D. Lee, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01999946
First received: November 26, 2013
Last updated: October 27, 2014
Last verified: October 2014
  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 Opioid 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:
  • Time-to-Relapse: XRNTX vs. ETAU following release from jail [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized ETAU following release from jail measured up to 24 weeks by Urine Toxicology results and self-report on the TLFB.


Secondary Outcome Measures:
  • Time-to-relapse: XR-NTX vs. Methadone (MTP) cohort following release from jail [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Our secondary aim is to measure time-to-relapse among XR-NTX vs. the non-randomized observational Methadone (MTP) cohort up to 24 weeks following release from jail and measured by Urine Toxicology results and self-report on the TLFB.

  • Community treatment retention/initiation post-release [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Community treatment retention/initiation across all arms at 8 and 24 weeks post-release using the Economic Form 90.

  • Any drug or alcohol misuse [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Any opioid, alcohol, or other illicit drug misuse, defined as continuous counts of both days, amount/day, and urine toxicologies for heroin or other illicit opioid and other drug use across all arms up to 24 weeks post-release and measured by Urine Toxicology Results and the TLFB.

  • Injection drug use and HIV sexual risk factors [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Injection drug use and HIV sexual risk factors will be assessed across all arms measured at 4, 8, and 24 weeks post-release from jail and measured using the Risk Assessment Battery.

  • Accidental drug overdose and mortality [ Time Frame: up to 28 weeks ] [ Designated as safety issue: No ]
    Accidental drug overdose and mortality across all arms assessed at each follow-up study visit up to 28 weeks post-release from jail measured by self report on the Opioid-Overdose AE/SAE form.

  • Re-incarceration and exploratory cost-effectiveness [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Re-incarceration and exploratory cost-effectiveness will be assessed across all arms up to 24 weeks post-release and measured using self-report on the Arrests and Days Incarcerated form and information received from the NYC DOC Inmate Locator online. Cost-effectiveness will be assessed across all arms and measured by the Economic Form 90.


Estimated Enrollment: 255
Study Start Date: June 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: January 2018 (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 and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Due to the nature of this study, which includes both randomized arms (XR-NTX and enhanced TAU) as well as a non-randomized observational arm (methadone treatment group, MTP) there are separate Inclusion/Exclusion criteria for those randomized vs. Non-Randomized, detailed below.

Randomized Arms (XR-NTX, ETAU)

Inclusion Criteria:

  1. Adults >18yo incarcerated in NYC jails with known release dates.
  2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
  3. Not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release.
  4. Currently opioid free by history ('detoxed') and with a negative urine for all opioids.
  5. General good health as determined by medical evaluation.

Exclusion Criteria:

  1. Pregnancy, lactation, or planning conception.
  2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
  3. Untreated or poorly controlled psychiatric disorder precluding safe participation.
  4. History of allergic reaction to naltrexone.
  5. Current chronic pain condition treated with opioids.

Non-Randomized Arm (MTP) Inclusion Criteria

  1. Adults >18yo incarcerated in NYC jails with known release dates.
  2. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
  3. Currently receiving regular methadone maintenance treatment through KEEP.
  4. General good health as determined by medical evaluation.

Exclusion Criteria

  1. Pregnancy, lactation, or planning conception.
  2. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation.
  3. Untreated or poorly controlled psychiatric disorder precluding safe participation.
  4. In community methadone treatment program at the time of most recent arrest.
  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 Active, not recruiting
New York, New York, United States, 10016
NYC Department of Corrections: Rikers Island Jail Facilities Recruiting
New York, New York, United States, 11370
Principal Investigator: Joshua D Lee, MD, MSc         
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: Joshua D. Lee, Assistant Professor, 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: October 27, 2014
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:
Opioid-Related Disorders
Heroin Dependence
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 November 27, 2014