Funding Source
NIDA Clinical Trials Network, CTN-0158
Project Period
3/1/25-2/28/29
Principal Investigator
Marc Fishman, MD (New York Node, Johns Hopkins University School of Medicine, Maryland Treatment Centers); Lisa A. Marsch, PhD (Northeast Node, Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth); Edward Nunes, MD (New York Node, New York University School of Medicine)
Other Project Staff
Co-Investigators: Kevin Wenzel, PhD, Maryland Treatment Centers; Jacob Borodovsky, PhD, Northeast Node, CTBH; Steven H. Chapman, MD (Dartmouth-Hitchcock Clinic); Elizabeth Saunders, PhD (Northeast Node, CTBH, Project Co-Director).
Scientific Officer: Geetha Subramaniam, MD, NIDA CCTN.
Research Team: Chantal Lambert-Harris, MA, Co-Project Director, Northeast Node; Luciana Lavorato, MA, Maryland Treatment Centers; Emma Fredyma, BS, Regulatory Manager, Northeast Node; Samuel White, CphT, Research Coordinator, Northeast Node; Bethany McLeman, BA, Node Coordinator, Northeast Node.
Project Summary
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 15-21 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. This study will also use ecological momentary assessment (EMA) to assess in-the-moment predictors of opioid use, including stress, self-regulation, sleep, withdrawal symptoms, and substance use risk context among adolescents with OUD.
Public Health Relevance
With opioid mortality data showing increases in overdose deaths among adolescents, developing safe, effective, and engaging models of care for adolescents with OUD is critical. This study will produce seminal knowledge on the effectiveness and sustainability of MOUD for adolescents with OUD, including data that will impact national models of care and provide a path forward for safe and effective treatment in this critical vulnerable population.