A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration (CTN-0087)
This project initiated the largest virtual cohort of patients with OUD on BUP-MOUD. The project achieved a deeper understanding and uncovered contextual issues associated with care, including quality of care provided in each setting. Our results describe BUP-MOUD’s natural course (duration, treatment episodes) and treatment settings; thus helping providers and policymakers understand primary and mental health care environmental contexts.
Node PI: Adam Gordon, MD, MPH
Validation of a Community Pharmacy-based Prescription Drug Monitoring Program Risk Screening Tool (PHARMSCREEN) (NIH HEAL Initiative) (CTN-0093)
Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids have continued to increase across the US—increasing in 35 states from 2013-2017. Given these persistent trends for adverse opioid-related outcomes in populations across the US, it is critical to work to identify those who are at risk, deliver appropriate care that will help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to those who suffer from opioid use disorder (OUD). Therefore, it is necessary to expand the continuum of care to health care settings that previously may have been underutilized. One underutilized resource for addressing the current opioid epidemic is community pharmacies. The most important clinical tool pharmacists have available to identify possible misuse of opioid medications is prescription drug monitoring programs (PDMP), which capture patient-level prescription dispensing information to inform monitoring, dispensing decisions, and possible intervention. These tools are available in all US states and have the potential to enable pharmacists to identify patients at-risk for opioid-related adverse events, such as addiction and overdose. In light of the continued escalation of the opioid epidemic nationally, combined with the promising opportunities afforded by the further inclusion of community pharmacy settings for engaging patients with opioid-related risk, it was important to evaluate whether PDMP risk metrics correlated with clinically validated opioid risk tools and if clinically meaningful risk cutoffs existed for PDMP risk metrics.
Node PI: Gerald Cochran, PhD, MSW
MOMs (CTN-0080)
The primary objective of the Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs) Study is to evaluate the impact of treating opioid use disorder (OUD) in pregnant women with extended-release (XR) buprenorphine (BUP), compared to sublingual (SL) BUP, on mother and infant outcomes. The primary hypotheses are that the BUP-XR, relative to the BUP-SL, group will have significantly: 1) less illicit opioid use during pregnancy; 2) shorter infant hospital length of stay (LOS); and 3) greater postpartum BUP adherence. Testing conceptual models of the mechanisms by which BUP-XR may improve mother-infant outcomes, relative to BUP-SL, is a secondary trial objective. Determining the economic value of BUP-XR, compared to BUP-SL, to treat OUD in pregnant women is a tertiary objective.
Node PI: Jerry Cochran, PhD, MSW
PI: Jerry Cochran, PhD, MSW and Marcela Smid, MD, MA, MS
Lead Coordinator: Grace Humiston (grace.humiston@hsc.utah.edu) and Elysha Cash (elysha.cash@hsc.utah.edu)
ED-INNOVATION (CTN-0099)
ED-INNOVATION is currently recruiting, training, and providing resources to 30 Emergency Department (ED) sites throughout the U.S. to implement ED-initiated buprenorphine (BUP) for patients presenting with untreated opioid use disorder (OUD). ED-INNOVATION is a pragmatic randomized clinical trial (RCT) comparing the effectiveness of sublingual buprenorphine (SL-BUP) versus a 7-day extended-release formulation of buprenorphine (XR-BUP) in 2000 patients with untreated OUD will be conducted in sites achieving competence (e.g. demonstrating ability to enroll patients with OUD and adhere to protocols for administering both formulations of buprenorphine). The primary outcome will be engagement in formal addiction treatment within 7-days post ED visit. Engagement in formal addiction treatment on the 30th day post randomization and cost effectiveness is also being studied.
PI: Peter P. Taillac, MD
Node PI: Jerry Cochran, PhD, MSW
Lead Coordinator: Andriea Merie Smith (andriea.smith@hsc.utah.edu)
Healthy Living Study (CTN-0101)
The Healthy Living Study is currently testing an intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adult primary care patients. This study is a collaborative care intervention consisting of: (1) A practice-embedded nurse care manager who provides patient education and supports the primary care provider in engaging and monitoring patients who have unhealthy opioid use; (2) Brief advice delivered to patients by their PCP and a pre-recorded ‘video doctor’; and (3) Telephone counseling by health coaches and mental health providers to motivate and support behavior change. This study consists of five primary care clinical sites from across the nation. Primary care providers will be randomized to receive either the Healthy Living intervention or treatment as usual. Patients are recruited by research staff based on unhealthy opioid use and if they are in the care of a participating PCP. Patients participate for 12 months. The study enrolls patients who have unhealthy opioid use.
PI: Adam Gordon, MD, MPH
Node PI: Adam Gordon, MD, MPH
Lead Coordinator: Kathryn Szczotka, MPH (kathryn.szczotka@hsc.utah.edu)
PHARMICO (CTN-0116)
The Implementing a Pharmacist-Integrated Collaborative Model of Medication Treatment for Opioid Use Disorder (PharmICO) Study will implement a specific model at four diverse sites across the United States. Study teams will employ a longitudinal mixed-methods approach to evaluate the feasibility, acceptability, and impact of implementing this model at the four sites.
PI: Nicholas Cox, PharmD
Node PI: Jerry Cochran, PhD, MSW
Lead Coordinator(s): Kathryn Szczotka, MPH (kathryn.szczotka@hsc.utah.edu)