A Scoping Review of Clinical Trials Evaluating Medications for Adolescents With Substance Use Disorders.

Abstract

Treatment recommendations for substance use disorder (SUD) emphasize medication as a key component of optimal care. Nonetheless, US Food and Drug Administration (FDA)-approved options for adolescents with SUD are limited. The purpose of this study was to systematically assess the number and characteristics of clinical trials testing medications for SUD in adolescent populations (aged <18) during the past 25 years. We performed a scoping review to identify randomized-controlled trials of medications for SUD that were available in Cochrane CENTRAL or clinicaltrials.gov, active between January 1, 1999 and December 4, 2024, and included at least one participant aged 13-17, with none aged 26 years or older. Key study characteristics were extracted and analyzed to identify trends in design, medications tested, and participant diversity. Thirty-six trials of 15 unique medications met the inclusion criteria. Of these, 26 had published results, one was currently active, 3 had reported results on clinicaltrials.gov but lacked a publication, and 6 had not yet reported their results in any form. Medications for nicotine use disorder were most commonly studied (41.7%, N = 15), while stimulant use disorder (2.7%, N = 1) and benzodiazepine use disorder (N = 0) were the least represented. Although the collection and reporting of demographic-related factors were inconsistent, the demographic data available demonstrated low participation of individuals aged younger than 18, racial/ethnic minorities, and gender-diverse youth. The current evidence base informing medications to treat SUD in adolescents is small. Additional research is urgently needed to address knowledge gaps, enhance participant diversity, and promote access to evidence-based SUD treatment for youth.