Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial

Background and Aims Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended‐release naltrexone (XR‐NTX) as relapse prevention among opioid‐dependent male adults leaving a large urban jail. Design Eight‐week, proof‐of‐concept, open‐label, non‐blinded randomized effectiveness trial. Setting New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. Participants From January 2010 to July 2013, 34 opioid‐dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR‐NTX (n = 17) versus no medication (n = 17) within one week prior to jail release. Intervention XR‐NTX (Vivitrol®; Alkermes Inc.), a long‐acting injectable mu opioid receptor antagonist. Measures The primary intent‐to‐treat outcome was post‐release opioid relapse at week 4, defined as ≥10 days of opioid misuse by self‐report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re‐incarceration and overdose. Findings Acceptance of XR‐NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR‐NTX participants: 38 versus 88% [P