NIH HEAL Initiative, NIDA Clinical Trials Network, CTN-0147
9/20/2023 – 9/19/2027
Marc Fishman, MD (Greater New York Node, Johns Hopkins University School of Medicine); Lisa A. Marsch, PhD (Northeast Node, Center for Technology and Behavioral Health, Geisel School of Medicine at Dartmouth)
Other Project Staff
Co-Investigators: Sharon Levy, MD, MPH, New England Node; Jacob Borodovsky, PhD, Northeast Node. Scientific Officer: Geetha Subramaniam, MD, NIDA CCTN. Research Team: Chantal Lambert-Harris, MA, Project Director; Emma Fredyma, BS, Research Coordinator; Owen Murray, MA, MS, LMFT, Regulatory/Quality Assurance Manager; Bethany McLeman, BA, Node Coordinator, Northeast Node
Young adults (YAs) are disproportionately affected by the current opioid crisis, with the highest rates of non-medical prescription opioid and heroin/fentanyl use across the lifespan and catastrophic outcomes for individuals and families. Although Medication for Opioid Use Disorder (MOUD) is effective for youth, current models of Opioid Use Disorder (OUD) treatment for youth have fallen short. Families are a potential source of robust support for treatment including referral, initiation, adherence and retention but are vastly underutilized in standard youth OUD treatment. Families are known to have motivational influences through enduring relationships that can support getting and keeping their loved ones in treatment. Community Reinforcement Approach and Family Training (CRAFT) is a strongly evidence-based treatment that has shown broad effectiveness for improving treatment initiation and engagement.
This project will adapt the empirically-supported CRAFT therapeutic model to use the leverage of families or other concerned significant others (CSOs) to increase treatment initiation and retention and improve the effectiveness of MOUD treatment for young adults (ages 18-26) – a population with relatively poor MOUD engagement and clinical outcomes.
CTN-0147 is a randomized controlled trial of the adapted CRAFT intervention partnering with four clinical sites within the Clinical Trials Network. CSOs and YAs will be recruited to participate through online marketing strategies and randomly assigned to receive either CRAFT or treatment as usual at the partnering site. The primary outcome is YA MOUD initiation, with treatment entry and treatment retention measured secondarily. Outcome measures include: (1) Percent of YAs in each arm who receive at least one dose of MOUD; (2) Percent of YAs in each arm who start treatment at the treatment site (which could even be a single intake/clinical visit in person or remotely; (3) Percent YA retention in MOUD across arms across 6 months.
Public Health Relevance
This project will provide sorely needed empirical information that may inform national treatment models to enhance engagement and treatment outcomes for a young population with OUD.