A single site, open-label, non-blinded randomized controlled trial, this study examines the effectiveness of using 6 months of extended-release naltrexone (XR-NTX) as opioid relapse prevention at release from a New York City jail compared to an enhanced treatment-as-usual (ETAU) condition. A non-randomized, quasi-experimental naturalistic cohort of adults newly initiating jail-to-community methadone treatment was recruited for additional non-random comparisons to an opioid agonist standard-of-care. The primary outcome of effectiveness or “time to relapse” was defined as four weeks of missing or positive urine toxicology or seven or more self-reported days of non-prescribed opioid use.

There were 217 adults enrolled in the study and 119 were successfully randomized. The XR-NTX group totaled 61 adults, ETAU numbered 58, and a methadone cohort included 79 adults. So far, XR-NTX was associated with marginally higher relapse-free survival and higher rates of opioid-negative urine samples versus ETAU at release from jail through 24 weeks. The final effect size estimates are pending. The XR-NTX cohort appeared to be associated with less post-release opioid misuse than that observed in a quasi-experimental methadone maintenance cohort. XR-NTX appeared safe and feasible; 24 percent retention at 24 weeks is similar to other recent MOUD jail-to-community cohort studies.

This study is sponsored by the National Institute on Drug Abuse (U01DA033336).