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BACKGROUND AND AIMS: Opioid agonist treatment is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings world-wide. This study assessed the safety of subcutaneous slow-release depot buprenorphine in custody. SETTING: This is an open-label, non-randomized trial conducted in correctional centres in New South Wales, Australia. Sixty-seven men and women, aged ≥ 18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder currently serving a custodial sentence of ≥ 6 months were recruited between November 2018 and July 2019. Patients not in opioid agonist treatment at recruitment commenced depot buprenorphine; patients already stable on oral methadone treatment were recruited to the comparison arm. INTERVENTION AND COMPARATOR: Depot buprenorphine (CAM2038 weekly for 4 weeks then monthly) and daily oral methadone. Safety was assessed by adverse event (AE) monitoring and physical examinations at every visit. Participants were administered a survey assessing self-reported diversion and substance use at baseline and weeks 4 and 16. FINDINGS: Retention in depot buprenorphine treatment was 92.3%. Ninety-four per cent of patients reported at least one adverse event, typically mild and transient. No diversion was identified. The prevalence of self-reported non-prescribed opioid use among depot buprenorphine patients decreased significantly between baseline (97%) and week 16 (12%, odds ratio = 0.0035, 95% confidence interval = 0.0007-0.018, P

Background: Opioid agonist treatment (OAT) is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings worldwide. Methods: This open-label trial compared depot buprenorphine, CAM2038 (weekly for 4 weeks then monthly) to oral methadone ( https://www.anzctr.org.au ACTRN12618000942257). Modelled treatment costs included a comparison group on sublingual buprenorphine-naloxone. Men and women, aged>18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder and a custodial sentence of at least six months were recruited from correctional centres in New South Wales, Australia. Findings: Between November 2018 and July 2019, 67 patients not in OAT treatment at recruitment commenced depot buprenorphine. Sixty-two patients already stable on oral methadone treatment were recruited to the comparison arm. Patients treated with depot buprenorphine commonly reported at least one adverse event related to study drug (63/67, 94%), typically mild and transient. No diversion of depot buprenorphine was identified. Retention in depot buprenorphine treatment was 92%. Self-reported use of non-prescribed opioids (primarily buprenorphine-naloxone) and injecting drug use decreased significantly among depot buprenorphine patients by 16 weeks (p