Our Research

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Research that Utilizes the GIN as a Project Site:

Upcoming Research

Research Being Led by the GIN:

Validation of a Community Pharmacy-based Prescription Drug Monitoring Program Risk Screening Tool (PHARMSCREEN) (NIH HEAL Initiative)

Principal Investigator: Gerald Cochran, PhD MSW

Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids has continued to increase across the US—continuing to increase 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 is important to evaluate whether current PDMP risk metrics correlate with clinically validated opioid risk tools and if clinically meaningful risk cutoffs exist for PDMP risk metrics.

A Foundation to Examine Reasons for Discontinuation for Buprenorphine Care in the Veterans Health Administration  

Principal Investigator: Adam J. Gordon, MD MPH FACP DFASAM

This project will initiate the largest virtual cohort of patients with OUD on BUP-MOUD. The proposed project will achieve a deeper understanding and uncover contextual issues associated with care, including quality of care provided in each setting. Our results will 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.

Research that Utilizes the GIN as a Project Site:

Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a pragmatic randomized trial comparing two buprenorphine formulations

Site Principal Investigator(s): Gerald Cochran, PhD MSW and Marcela C. Smid, MD MS MA

The growing opioid-use epidemic in the U.S. has been associated with a significant increase in the prevalence of pregnant women with opioid use disorder (OUD) and neonatal abstinence syndrome (NAS)/neonatal opioid withdrawal syndrome (NOWS). NAS/NOWS is associated with adverse health effects for the infant and with costly hospitalizations.6 In 2012, the average length of stay (LOS) for NAS/NOWS was 16.9 days and the average cost was $66,700. In 2013, about 4% of total neonatal intensive care unit days were attributed to infants with NAS/NOWS, compared to just 0.6% in 2004.10 The American College of Obstetricians and Gynecologists Committee together with the American Society of Addiction Medicine published their recommendation in 2012 that opioid-dependent pregnant women should not be tapered off opioids and should be treated with methadone or, possibly, buprenorphine (BUP); a more definitive recommendation for either methadone or BUP treatment was made by the WHO in 2014.1This opinion has been maintained based on more recent literature reviews, and the relative advantages/disadvantages of each treatment approach have been further delineated. Relative to methadone, BUP offers the advantages of greater convenience for pregnant women and lower NAS/NOWS severity in their infants. Some disadvantages of BUP include increased risk of diversion, poorer adherence, greater treatment dropout, and daily peak-trough effects. While applicable to individuals with OUD in general, these disadvantages may be more pronounced in pregnant women.

*If you are a pregnant individual (18-41 years old) and interested in enrolling in MOMs, find out how here.

Emergency Department-INitiated BupreNOrphine VAlidaTIOn Network Trial (CTN 0099)

Site Principal Investigator(s): Peter P. Taillac, MD and Troy Madsen, MD

ED-INNOVATION will recruit, train and provide 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).  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 will also be studied.

 

Upcoming Research

Healthy Living Study (CTN-0101)

The Greater Intermountain Node and University of Utah Health have been selected as a site for the Healthy Living Study. CTN-0101 will test an intervention to reduce opioid use and overdose risk, and prevent progression to OUD, in adult primary care patients. CTN-0101 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. CTN-0101 will consist 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 will recruited by research staff based on unhealthy opioid use and if they are in the care of a participating PCP. Patients will participate for 12 months. The study will enroll patients who have unhealthy opioid use. Research assistants follow up with patients and collect data off-site (by telephone, internet).

Optimizing Retention, Duration, and Discontinuation Strategies for Opioid
Use Disorder Pharmacotherapy (RDD) Study

RDD is funded by the National Institute of Health (NIH) HEAL Initiative℠. Lead site principal investigators are Edward V. Nunes, Jr., MD (Columbia University), John Rotrosen, MD (New York  University), and Roger D. Weiss, MD (Harvard University).

This study will 1) test strategies to improve OUD pharmacotherapy treatment retention and to improve outcomes among patients who have been successfully stabilized on OUD medications and want to stop medication; and 2) identify predictors of successful outcome and develop a stage model of relapse risk.