Extended-Release Naltrexone for Opioid Relapse Prevention Following Release From Jail

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.
  
  

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.