Clinical Trial: Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry

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 Summary:

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
Sponsor: New York University School of Medicine

Current Primary Outcome: Time-to-Relapse: XRNTX vs. ETAU following release from jail [ Time Frame: up to 24 weeks ]

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.


Original Primary Outcome: DSM-5 Opioid Use Disorder Diagnosis [ Time Frame: 6 months ]

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.


Current Secondary Outcome:

  • Time-to-relapse: XR-NTX vs. Methadone (MTP) cohort following release from jail [ Time Frame: up to 24 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • HIV risk behavior [ Time Frame: Baseline, 3, 6 and 12 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.


Information By: New York University School of Medicine

Dates:
Date Received: November 26, 2013
Date Started: June 2014
Date Completion: May 2018
Last Updated: December 16, 2016
Last Verified: December 2016