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

Primary Purpose

Heroin Dependence, Opioid-Related Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended-Release Naltrexone
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring Heroin Dependence, Opioid-Related Disorders

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bellevue Hospital Center
  • NYC Department of Corrections: Rikers Island Jail Facilities

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Extended-Release Naltrexone (XR-NTX)

Enhanced Treatment As Usual (ETAU)

Methadone Treatment Program (MTP)

Arm Description

Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.

Enhanced Treatment As Usual arm will not receive any study medication, but will receive 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.

Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.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. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.

Outcomes

Primary Outcome Measures

Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail
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
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
Community treatment retention/initiation across all arms post-release using the Economic Form 90.
Any Drug or Alcohol Misuse
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
Injection drug use and HIV sexual risk factors will be assessed across all arms measured post-release from jail and measured using the Risk Assessment Battery.
Accidental Drug Overdose and Mortality
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
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.

Full Information

First Posted
November 26, 2013
Last Updated
June 2, 2021
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), Friends Research Institute, Inc., University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01999946
Brief Title
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Acronym
XOR
Official Title
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2014 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
December 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), Friends Research Institute, Inc., University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This study is a randomized control trial of XR-NTX (n=85) vs. enhanced TAU (n=85) among opioid dependent adults leaving NYC jails who explicitly reject agonist treatment. Initiating treatment the week prior to release and continuing for 24 weeks post-release, we hypothesize the XR-NTX arm will demonstrate significantly longer time-to-relapse vs. TAU. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort (n=85), which will result in a naturalistic comparison of XR-NTX vs. an established jail-based MTP standard-of-care. Rationale: Immediate relapse to drug, alcohol, and tobacco use is a nearly universal and expected near-term outcome among adults with addiction disorders leaving U.S. jails. Yet while opioid agonist therapies are proven and effective re-entry interventions, many US correctional facilities, including almost all large U.S. municipal jails, do not offer these treatments. However, in New York City (NYC), jail-to-community methadone treatment is, since 1986, a well-studied standard-of-care, yet many inmates eligible to initiate the methadone treatment program (MTP) while incarcerated do not, possibly due to anti-methadone patient preferences. Rather, the vast majority of these jail detainees undergo a brief 6-day methadone taper following arrest, remain in jail for brief periods out-of-treatment while 'drug free' and undergoing a decline in physiologic opioid tolerance, nearly universally relapse to heroin or other illicit opioid use following release, and are re-arrested in the next 12 months at rates of 50-75%. Extended-release naltrexone (XR-NTX, Vivitrol), now FDA-approved for opioid dependence, produces a 30-day mu opioid receptor antagonist blockade, and offers an potentially promising modality for 'inoculating' persons leaving jails against immediate opioid relapse. Persons injected with 380mg of XR-NTX are unable to effectively experience euphoria or respiratory depression when returning to average doses of illicit opioids for the ensuing 4-5 weeks. An injection prior to release would possibly give the individual a month or so to return home from jail, experience opioid abstinence, and then either continue XR-NTX, initiate agonist or behavioral treatments, or, resume a significantly postponed relapse to illicit use. Our team recently established the feasibility of administering XR-NTX to opioid dependent adults within a week of release in NYC jails. We now propose to conduct a large, definitive randomized controlled trial estimating the effectiveness of XR-NTX as opioid treatment at release from jail vs. a counseling- and referral-enhanced treatment-as-usual (TAU) condition. We also propose to recruit a non-randomized, quasi-experimental cohort of participants in a jail-based methadone maintenance program (MTP), allowing an additional comparison of XR-NTX to a methadone standard-of-care. Specific Aim 1: Randomized Effectiveness Trial of XR-NTX vs. TAU for Jail-to-Community Re-Entry Opioid Relapse Prevention. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls, following release from jail. Specific Aim 2: Quasi-Experimental Comparison of XR-NTX vs. a Methadone Treatment Program for Re-Entry Opioid Relapse Prevention. To compare time-to-relapse among the XR-NTX RCT arm vs. jail-based MTP participants using a quasi-experimental design. Specific Aim 3a-e: Related Opioid Treatment Outcomes. To compare re-entry rates of 5 treatment outcomes across all arms: 3a) community treatment initiation and retention, 3b) any opioid and other illicit drug or alcohol use, defined as continuous counts of both days, amount/day, and urine toxicologies, 3c) injection drug use and HIV sexual risk factors, 3d) accidental drug overdose and mortality, and, 3e) rates of re-incarceration and an exploratory analysis of cost-effectiveness. Implications: While there is growing interest in the newly approve use of XR-NTX for opioid treatment, its effectiveness has not been evaluated in any correctional facilities, including large municipal jails, vs. usual care, nor in the context of standard-of-care methadone treatment. This study will allow providers, correctional and public health authorities, including our collaborators at the NYC Department of Health and Mental Hygiene, and payers and policy makers to assess the utility of XR-NTX as re-entry opioid treatment, with important implications for limiting the great public safety and societal costs of heroin and prescription opioid addictions. Further, NYC jail inmates are predominantly African American and Hispanic, and represent communities disproportionately affected by unemployment, family poverty, HIV and hepatitis C, all downstream effects of opioid dependence. As the majority of opioid addicted persons leave jail return to their neighborhoods untreated and prone to rapid relapse, we hypothesize adding XR-NTX to the re-entry 'toolbox' will save both money and lives in these under-served communities. This study is part of the NIDA "Studies of Medication for Addiction Treatment in Correctional Settings (SOMATICS)" U01 Collaborative. Our distinct NIH-funded study at NYU has been aligned with two other jail-based opioid treatment studies conducted by researchers at Friends Research Institute (FRI) in Baltimore, MD, and at UCLA. SOMATICS seeks to harmonize assessments and interventions across the three research centers (RCs) and the three independent studies in order to leverage power, sample size, and increase the generalizability of findings. Each of the RCs in the SOMATICS cooperative will conduct their own individual trial, sharing one study arm with another RC, and several core assessments across all sites. The SOMATICS collaborative will have a common Statistical Analysis Plan and DSMP including a single DSMB. The collaborative primary and secondary outcomes across all sites are listed below: Collaborative Primary Outcome Measures: 1. DSM-5 Opioid Use Disorder Diagnosis during the 30 days prior to the 6 months post-release follow-up assessment: Measured by: DSM-5 checklist via a modified CIDI-2 Substance Abuse Module. Collaborative Secondary Outcome Measures: Illicit Opioid use: measured by urine drug testing results at 6 months post-release Number of days incarcerated: Measured by self-report during the 6 months post-release. HIV risk behavior: Measured by self-report (Drug Risk Assessment Battery [RAB] Needle Use score) at the 6-month post-release follow-up assessment. Number of days of Opioids, Cocaine, Alcohol, Benzodiazepines, and/or IV Drug Use: Measured by Time Line Follow Back at 6 months post-release follow-up (TLFB; NYU, UCLA) and ASI (FRI). Non-opioid drug use (Cocaine, Amphetamines, and Benzodiazepines): measured by urine drug testing at 6 months post-release Number of days in any drug abuse treatment: Measured by self-report at 6 months post-release. Number of arrests: Measured by self-report data collected at 6 months post-release. Craving scores (for NYU and UCLA sites only): Measured by self-report craving scale at 6 months post-release. Non-lethal overdose (Yes/No): Measured by self-report during the 6 months post-release. Lethal overdose (Yes/No): Measured by public records data reviewed at 6 months post-release. WHO Quality of Life-BREF (WHOQOL-BREF) score: Measured by self-report at 6 months post-release. Analyses of above same secondary outcomes at 12 months follow-up. Analyses of above same secondary outcomes at 24 months follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heroin Dependence, Opioid-Related Disorders
Keywords
Heroin Dependence, Opioid-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended-Release Naltrexone (XR-NTX)
Arm Type
Experimental
Arm Description
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Arm Title
Enhanced Treatment As Usual (ETAU)
Arm Type
No Intervention
Arm Description
Enhanced Treatment As Usual arm will not receive any study medication, but will receive 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.
Arm Title
Methadone Treatment Program (MTP)
Arm Type
No Intervention
Arm Description
Quasi-Experimental cohort, will be participants recruited from NYC Rikers Island jail's Key Extended Entry Program (KEEP)'s jail methadone maintenance program, they will not receive any intervention from study, but will receive enhancement counseling centered on post-release treatment involvement and a patient-drug educational handout with direct referrals to re-entry community treatment.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. MTP participants are new KEEP methadone participants not enrolled in community methadone at the time of arrest.
Intervention Type
Drug
Intervention Name(s)
Extended-Release Naltrexone
Other Intervention Name(s)
Vivitrol, XR-NTX
Intervention Description
Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
Primary Outcome Measure Information:
Title
Time-to-Relapse: XRNTX vs. ETAU Following Release From Jail
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Time-to-relapse: XR-NTX vs. Methadone (MTP) Cohort Following Release From Jail
Description
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.
Time Frame
up to 24 weeks
Title
Community Treatment Retention/Initiation Post-release
Description
Community treatment retention/initiation across all arms post-release using the Economic Form 90.
Time Frame
up to 24 weeks
Title
Any Drug or Alcohol Misuse
Description
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.
Time Frame
up to 24 weeks
Title
Injection Drug Use and HIV Sexual Risk Factors
Description
Injection drug use and HIV sexual risk factors will be assessed across all arms measured post-release from jail and measured using the Risk Assessment Battery.
Time Frame
up to 24 weeks
Title
Accidental Drug Overdose and Mortality
Description
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.
Time Frame
up to 28 weeks
Title
Re-incarceration and Exploratory Cost-effectiveness
Description
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.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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: Adults >18yo incarcerated in NYC jails with known release dates. DSM-V criteria for current opioid use disorder (DSM-IV 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 medical evaluation. Exclusion Criteria: Pregnancy, lactation, or planning conception. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation. Untreated or poorly controlled psychiatric disorder precluding safe participation. History of allergic reaction to naltrexone. Current chronic pain condition treated with opioids. Non-Randomized Arm (MTP) Inclusion Criteria Adults >18yo incarcerated in NYC jails with known release dates. DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence). Currently receiving regular methadone maintenance treatment through KEEP. General good health as determined by medical evaluation. Exclusion Criteria Pregnancy, lactation, or planning conception. Active medical illness (i.e., severe liver disease, congestive heart failure) precluding safe participation. Untreated or poorly controlled psychiatric disorder precluding safe participation. In community methadone treatment program at the time of most recent arrest.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua D Lee, MD MS
Organizational Affiliation
NYU MEDICAL CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYC Department of Corrections: Rikers Island Jail Facilities
City
New York
State/Province
New York
ZIP/Postal Code
11370
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31570100
Citation
Velasquez M, Flannery M, Badolato R, Vittitow A, McDonald RD, Tofighi B, Garment AR, Giftos J, Lee JD. Perceptions of extended-release naltrexone, methadone, and buprenorphine treatments following release from jail. Addict Sci Clin Pract. 2019 Oct 1;14(1):37. doi: 10.1186/s13722-019-0166-0.
Results Reference
derived
PubMed Identifier
27178765
Citation
McDonald RD, Tofighi B, Laska E, Goldfeld K, Bonilla W, Flannery M, Santana-Correa N, Johnson CW, Leibowitz N, Rotrosen J, Gourevitch MN, Lee JD. Extended-release naltrexone opioid treatment at jail reentry (XOR). Contemp Clin Trials. 2016 Jul;49:57-64. doi: 10.1016/j.cct.2016.05.002. Epub 2016 May 10. Erratum In: Contemp Clin Trials. 2016 Nov;51:96.
Results Reference
derived

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Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

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