CTN-0158: Extended-Release vs. Sublingual Buprenorphine for Adolescent Opioid Use Disorder (ERA) (NIH HEAL Initiative)
Mark Fishman, MD
Co-Principal Investigator
Maryland Treatment Centers
Johns Hopkins University School of Medicine
mfishman@marylandtreatment.org
Lisa A. Marsch, PhD
Co-Principal Investigator
Geisel School of Medicine at Dartmouth College
lisa.a.marsch@dartmouth.edu
Edward V. Nunes, Jr. MD
Co-Principal Investigator
Columbia University College of Physicians and Surgeons
New York State Psychiatric Institute
edward.nunes@nyspi.columbia.edu
Opioid use disorder (OUD) among adolescents is a major and worsening public health problem, with catastrophic consequences for youth and their families. While the safety and efficacy of medications for OUD (MOUD) for youth has been endorsed based on expert clinical consensus, uptake of MOUD among adolescents with OUD has been poor. Numerous barriers have prevented the uptake of MOUD for adolescents, including limited evidence on the effectiveness of MOUD from clinical trials, and lack of pediatric-specific FDA labeling for MOUD.
To address this gap, this study will conduct the first large-scale clinical trial of long-term buprenorphine maintenance treatment in adolescents (age 14-21 years) and compare the effectiveness of sublingual buprenorphine (SL-B) versus extended-release buprenorphine (XR-B). This randomized control trial will evaluate outcomes of treatment with monthly XR-B compared to daily SL-B in adolescents with moderate to severe OUD. The primary outcome is cumulative days adherent to MOUD over the 24-week trial. Additionally, this study will examine the sustainability of MOUD in the real world by measuring rates of transition from study treatment to community-based MOUD following the study treatment period, and will explore predictors of MOUD adherence, including participant characteristics and external factors (e.g., parental support, funding for care, types of community treatment programs providing MOUD).
Funded by the NIH HEAL Initiative®
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