Subthreshold Opioid Use Disorder Prevention (STOP) Trial

NIDA Clinical Trials Network (NIH HEAL Initiative), CTN-0101

6/1/2019 – 1/31/2023

Jennifer McNeely, MD, MS (NYU) and Jane Liebschutz, MD, MPH (University of Pittsburgh) (Multiple PIs)

Lisa Marsch, PhD (Geisel School of Medicine at Dartmouth College) and Hyunouk Hong, DO (Dartmouth-Hitchcock at Manchester) (Site PIs).

Team Members: Bethany McLeman, Emma Fredyma, Emily Halliday, Pamela Hofley, Rebecca Shore, Noa Appleton, Amanda Bunting, Sarah Farkas, Valarie Weinzierl, Alissa Eugeni, Joohahn Kim, MarySue Brissette, Kim Danis Eve Jelstrom, Leslie Revoredo, Kristen Antonellis, Jennifer Neal-Jimenez, Brett Hart, Jen McCormack, Gail Potter, Lauren Yesko, Rebecca Price, Ashley Case, Tobie Kim, Kathryn Hefner, Margaret Kline, and Geetha Subramaniam

Even in the midst of an opioid crisis that is driven by a high prevalence of untreated opioid use disorder (OUD), it is critically important to focus on prevention of OUD among individuals with subthreshold OUD. Subthreshold OUD is opioid use that is not severe enough to meet diagnostic criteria for moderate-severe OUD (that would require medication and more intensive treatment). As defined here, subthreshold OUD includes individuals with problem opioid use or mild OUD symptoms. Individuals with subthreshold OUD engage in risky opioid use behavior, which includes nonmedical use of prescribed opioids (taking a higher dose or taking an opioid more frequently than prescribed), any use of illicit opioids, or taking pharmaceutical opioids that were not prescribed to them. Although a minority (18%) of the 12 million Americans with past year illicit or nonmedical opioid use have an OUD, all of them are at high risk of developing OUD in the future.

This randomized clinical trial aims to examine the efficacy of a primary care Subthreshold Opioid Use Disorder Prevention (STOP) intervention to reduce opioid use and overdose risk, and to prevent progression of OUD in adult patients with risky opioid use. Specifically, STOP is a behavioral early intervention strategy targeting individuals with subthreshold OUD, with a goal of preventing the development of moderate-severe OUD. STOP is a collaborative care model consisting of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports the primary care provider (PCP) in engaging and monitoring patient participants who have risky opioid use; (2) brief advice delivered to patient participants by their PCP; and (3) telephonic health coaching of patient participants to motivate and support behavior change. Patient participants who fail to improve after the telephone health coaching sessions are stepped up to receive additional health coaching sessions that incorporate motivational interviewing and cognitive behavioral therapy.

A cluster-randomized trial, randomized at the level of the PCP, aims to test the efficacy of STOP versus enhanced usual care (EUC). The trial will be conducted in five primary care sites, and across all sites will enroll approximately 60 PCPs and 480 adult primary care patients. Additionally, a pilot study conducted at D-H Manchester and Bedford (one site, two locations), will test the recruitment, enrollment and survey procedures in advance of the main trial.

Like any public health epidemic, the opioid crisis requires a multi-pronged strategy that includes prevention as well as effective treatment. Primary care practices are optimally positioned to provide early intervention for unhealthy opioid use, but they are underutilized. The STOP intervention, if proven efficacious, will provide a solution to preventing OUD among patients who are most at risk, thus addressing a key aspect of the opioid epidemic.