Use of XR-NTX in the treatment of opioid use disorder in adolescents
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Abstract
Over the past 20 years, the use of non-prescription opioids has increased substantially in the United States, becoming an epidemic that effects all facets of American society. This public health crisis causes significant morbidity and mortality to those suffering with the disease and acts as a major burden to their families and the American healthcare system. To combat this issue, multiple medications have been developed to help treat patients with opioid use disorder. Buprenorphine, methadone and naltrexone are all FDA approved to treat OUD and have been successful in maintaining patients in recovery. Despite this, these medications are underutilized.
Adolescents and young adults (AYAs) represent a special population of those diagnosed with OUD as they are still developing neurologically and will have prolonged morbidity associated with OUD, if untreated. Like the general population, utilization of medication for OUD has decreased in AYAs, while diagnosis of OUD and overdose deaths have increased. Despite the attention that the opioid epidemic has received, studies focusing on medications for treatment of OUD in AYAs are sparse, particularly with Extended Release Naltrexone (XR-NTX). There is a single retrospective case-series on the use of XR-NTX in adolescents and young adults, but no randomized trials published in the United States. Although proven efficacious in the adult population, the lack of scientific data on the use of XR-NTX in AYAs may be contributing to its underutilization in this population.
This proposed study is an open-label, randomized trial comparing the effectiveness of XR-NTX to the standard of care, Buprenorphine-Naloxone (BUP-NX), in retaining AYAs in treatment. The study will be conducted over a period of 24 weeks and will include biweekly cognitive behavioral therapy sessions. In addition to retention in treatment, secondary endpoints of continued opioid use and cravings will be measured. The goal of this study is to assess the efficacy of naltrexone in treating OUD in AYAs. If proven efficacious, XR-NTX offers a unique treatment option for patients looking for an alternative to opioid agonist therapy.
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Attribution 4.0 International