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RDD (CTN-0100)

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD, CTN-0100). The RDD Study is a two-phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD): 

  • The Retention Phase objectives: to assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX).
  • The Discontinuation Phase objectives: to assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue or taper the use of Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue MOUD. 

PI: Jerry Cochran, PhD, MSW

Node PI: Adam Gordon, MD, MPH

Lead Coordinator: Priscilla Blosser (Priscilla.Blosser@hsc.utah.edu) and Brady Groneman

A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration (CTN-0087)

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.

PI: Adam Gordon, MD, MPH

Node PI: Adam Gordon, MD, MPH

PHARMSCREEN (CTN-0093)

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 continued to increase across the United States—increasing in 35 states from 2013 to 2017. Given these persistent trends in adverse opioid-related outcomes across the country, it was critical to identify those who were at risk, deliver appropriate care to help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to individuals with opioid use disorder (OUD). Therefore, it was necessary to expand the continuum of care to health care settings that had previously been underutilized. One such underutilized resource for addressing the opioid epidemic was community pharmacies. The most important clinical tool pharmacists had available to identify possible misuse of opioid medications was the prescription drug monitoring program (PDMP), which captured patient-level prescription dispensing information to inform monitoring, dispensing decisions, and potential intervention. These tools were available in all U.S. states and had 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 further inclusion of community pharmacy settings in engaging patients with opioid-related risk, it was important to evaluate whether PDMP risk metrics correlated with clinically validated opioid risk tools and whether clinically meaningful risk cutoffs existed for PDMP risk metrics.

PI: Adam Gordon, MD, MPH

Node PI: Jerry Cochran, PhD, MSW

MOMs (CTN-0080)

The primary objective of the Medication Treatment for Opioid Use Disorder in Expectant Mothers Study (MOMS, CTN-0080) was 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 was that the BUP-XR, relative to the BUP-SL, group would have significantly: 1) less illicit opioid use during pregnancy; 2) shorter infant hospital length of stay (LOS); and 3) greater postpartum BUP adherence. Tested 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 was a tertiary objective.

PI: Jerry Cochran, PhD, MSW and Marcela Smid, MD, MA, MS

Node PI: Jerry Cochran, PhD, MSW

Lead Coordinator: Grace Humiston (grace.humiston@hsc.utah.edu) and Elysha Cash

ED-INNOVATION (CTN-0099)

ED-INNOVATION (CTN-0099) recruited, trained, and provided 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 was 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 was 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 was also studied.

PI: Peter P. Taillac, MD

Node PI: Jerry Cochran, PhD, MSW

Lead Coordinator: Andriea Merie Smith

Healthy Living Study (CTN-0101)

The Healthy Living Study (CTN-0101) tested an intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adult primary care patients. This study was a collaborative care intervention consisting of: (1) A practice-embedded nurse care manager who provided patient education and supported the primary care provider in engagement and monitoring of patients who had 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 were randomized to receive either the Healthy Living intervention or treatment as usual. Patients were recruited by research staff based on unhealthy opioid use and if they were in the care of a participating PCP. Patients participate for 12 months. The study enrolled patients who had 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 Study (CTN-0116, PharmICO) implemented a specific model at four diverse sites across the United States. Study teams employed 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)