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

• Opioid treatment retention/initiation [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  This secondary outcome tracks other opioid treatment retention and/or initiation during the four weeks post-release.
• Any opioid use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  Rates of any opioid use, defined as continuous counts of both days and amount/day of heroin or other opioid use as measured by the Timeline Follow-Back assessment.
• Injection drug use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  This secondary outcome tracks any injection drug use and frequency of IDU 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.

• Opioid treatment retention/initiation [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  This secondary outcome tracks other opioid treatment retention and/or inititaion during the four weeks post-release.
• Any opioid use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  Rates of any opioid use, defined as continuous counts of both days and amount/day of heroin or other opioid use as measured by the Timeline Follow-Back assessment.
• Injection drug use [ Time Frame: Four weeks post-release ] [ Designated as safety issue: No ]
  This secondary outcome tracks any injection drug use and frequency of IDU 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 pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use >50% (>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

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.

• Drug: Extended-Release Naltrexone
  380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
  Other Name: Vivitrol
• Behavioral: Motivational Enhancement Counseling
  The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

• Active Comparator: Extended-release naltrexone (XR-NTX)
  A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.
  Intervention: Drug: Extended-Release Naltrexone
• Placebo Comparator: Motivational Enhancement Counseling Only
  The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
  Intervention: Behavioral: Motivational Enhancement Counseling

Inclusion Criteria:

• Adults incarcerated in NYC jails with known release date
• DSM-IV criteria for current opioid dependence
• No current agonist (methadone, buprenorphine) treatment
• Currently opioid free by history ('detoxed') and with a negative urine for all opioids
• General good health as determined by complete medical interview and physical examination
• Age 18-60 years.

Exclusion Criteria:

• History of liver failure, cirrhosis, or recent liver function test levels greater than three times normal
• Pregnancy, lactation, or planning conception
• Active medical illness that might make participation hazardous
• Untreated psychiatric disorder
• History of allergic reaction to naltrexone, PLG (polylactide co-glycolide), carboxymethylcellulose, or any other components of the diluent.
• Current chronic pain condition treated with opioids.