Browsing by Author "Liebschutz, Jane M"

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    Research priorities for expanding access to methadone treatment for opioid use disorder in the United States: A National Institute on Drug Abuse Center for Clinical Trials Network Task Force report.
    (Substance abuse, 2021-01) Joudrey, Paul J; Bart, Gavin; Brooner, Robert K; Brown, Lawrence; Dickson-Gomez, Julie; Gordon, Adam; Kawasaki, Sarah S; Liebschutz, Jane M; Nunes, Edward; McCarty, Dennis; Schwartz, Robert P; Szapocnik, José; Trivedi, Madhukar; Tsui, Judith I; Williams, Arthur; Wu, Li-Tzy; Fiellin, David A
    In the US, methadone treatment can only be provided to patients with opioid use disorder (OUD) through federal and state-regulated opioid treatment programs (OTPs). There is a shortage of OTPs, and racial and geographic inequities exist in access to methadone treatment. The National Institute on Drug Abuse Center for Clinical Trials Network convened the Methadone Access Research Task Force to develop a research agenda to expand and create more equitable access to methadone treatment for OUD. This research agenda included mechanisms that are available within and outside the current regulations. The task force identified 6 areas where research is needed: (1) access to methadone in general medical and other outpatient settings; (2) the impact of methadone treatment setting on patient outcomes; (3) impact of treatment structure on outcomes in patients receiving methadone; (4) comparative effectiveness of different medications to treat OUD; (5) optimal educational and support structure for provision of methadone by medical providers; and (6) benefits and harms of expanded methadone access. In addition to outlining these research priorities, the task force identified important cross-cutting issues, including the impact of patient characteristics, treatment, and treatment system characteristics such as methadone formulation and dose, concurrent behavioral treatment, frequency of dispensing, urine or oral fluid testing, and methods of measuring clinical outcomes. Together, the research priorities and cross-cutting issues represent a compelling research agenda to expand access to methadone in the US.
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    Subthreshold opioid use disorder prevention (STOP) trial: a cluster randomized clinical trial: study design and methods.
    (Addiction science & clinical practice, 2023-11) Liebschutz, Jane M; Subramaniam, Geetha A; Stone, Rebecca; Appleton, Noa; Gelberg, Lillian; Lovejoy, Travis I; Bunting, Amanda M; Cleland, Charles M; Lasser, Karen E; Beers, Donna; Abrams, Catherine; McCormack, Jennifer; Potter, Gail E; Case, Ashley; Revoredo, Leslie; Jelstrom, Eve M; Kline, Margaret M; Wu, Li-Tzy; McNeely, Jennifer

    Background

    Preventing progression to moderate or severe opioid use disorder (OUD) among people who exhibit risky opioid use behavior that does not meet criteria for treatment with opioid agonists or antagonists (subthreshold OUD) is poorly understood. The Subthreshold Opioid Use Disorder Prevention (STOP) Trial is designed to study the efficacy of a collaborative care intervention to reduce risky opioid use and to prevent progression to moderate or severe OUD in adult primary care patients with subthreshold OUD.

    Methods

    The STOP trial is a cluster randomized controlled trial, randomized at the PCP level, conducted in 5 distinct geographic sites. STOP tests the efficacy of the STOP intervention in comparison to enhanced usual care (EUC) in adult primary care patients with risky opioid use that does not meet criteria for moderate-severe OUD. The STOP intervention consists of (1) a practice-embedded nurse care manager (NCM) who provides patient participant education and supports primary care providers (PCPs) in engaging and monitoring patient-participants; (2) brief advice, delivered to patient participants by their PCP and/or prerecorded video message, about health risks of opioid misuse; and (3) up to 6 sessions of telephone health coaching to motivate and support behavior change. EUC consists of primary care treatment as usual, plus printed overdose prevention educational materials and an educational video on cancer screening. The primary outcome measure is self-reported number of days of risky (illicit or nonmedical) opioid use over 180 days, assessed monthly via text message using items from the Addiction Severity Index and the Current Opioid Misuse Measure. Secondary outcomes assess other substance use, mental health, quality of life, and healthcare utilization as well as PCP prescribing and monitoring behaviors. A mixed effects negative binomial model with a log link will be fit to estimate the difference in means between treatment and control groups using an intent-to-treat population.

    Discussion

    Given a growing interest in interventions for the management of patients with risky opioid use, and the need for primary care-based interventions, this study potentially offers a blueprint for a feasible and effective approach to improving outcomes in this population.

    Trial registration

    Clinicaltrials.gov, identifier NCT04218201, January 6, 2020.