Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1R24DA055306-01
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B Winston-Salem, NC 2021
NOFO Title: HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional)
NOFO Number: RFA-DA-21-029
Summary:

The IMPOWR (Integrative Management of Chronic Pain and OUD for Whole Recovery) Dissemination, Education, and Coordination Center (IDEA-CC) will develop infrastructure to amplify and create momentum for the findings of the IMPOWR initiative and other linked research networks. This center will i) rapidly deploy a communication framework to link IMPOWR clinical sites with each other and the larger HEAL research frameworks; ii) develop an educational infrastructure addressing stigma and health disparities in patients with co-morbid chronic pain and opioid misuse/disorder; iii) disseminate research findings effectively to targeted audiences; iv) develop a novel composite screening tool for chronic pain and opioid misuse/disorder; and v) harmonize processes for data collection and common data elements of chronic pain and opioid misuse/disorder measures across the IMPOWR research centers, providing a coordinated platform for gathering data from these studies. This center will rapidly disseminate key findings to stakeholders, clinicians, and patients to improve the health and wellbeing of individuals with co-occurring chronic pain and opioid misuse/disorder.
1U24DA058606-01
MIRHIQL Resource Center (MRC) for Improving Quality of Life with Chronic Pain Clinical Research in Pain Management Reducing Opioid-Related Harms to Treat Chronic Pain (IMPOWR and MIRHIQL) NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B (contact); HURLEY, ROBERT WILLSON Winston-Salem, NC 2023
NOFO Title: HEAL Initiative: Multilevel Interventions to Reduce Harm and Improve Quality of Life for Patients on Long Term Opioid Therapy (MIRHIQL): Resource Center (U24- Clinical Trial Optional)
NOFO Number: RFA-DA-23-042
Summary:

Decreasing opioid dosing faster than advised by clinical recommendations often leaves chronic pain unaddressed and may increase the risk of overdose and suicide compared to continuing long-term opioid treatment. Clinical and research communities are uncertain about how to assess and manage long-term opioid therapy, despite having diagnostic and treatment frameworks for chronic pain and opioid use disorder. Because of this undefined space, health policy, institutions, and practitioners lack clear advice on long-term opioid prescribing in chronic pain. The goal of the MRC is to provide infrastructure support for the network; create a risk-benefit decision tool to assist providers in determining when opioids should be continued as prescribed, tapered, or tapered/discontinued; and develop and validate a clinical definition for this population (name, identifying associated symptoms/behaviors, and generating a screening tool). This project will leverage big data analytics in administrative datasets, natural language processing approaches in electronic health records, and cohort modeling techniques to accomplish these key responsibilities. These efforts will complement the qualitative data collection approaches in the Becker Resource Center. 
R24DA055306-01
Wake Forest IMPOWR Dissemination Education and Coordination Center (IDEA-CC) NIDA Wake Forest University Health Sciences ADAMS, MEREDITH C B Winston-Salem, NC 2022
NOFO Title: Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data
NOFO Number: NOT-OD-22-067
Summary:

This research is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain and opioid use disorder or opioid misuse. To allow comparison and analysis of data created in nine unique clinical trials funded across four centers, common data elements (CDEs) were selected to assess all aspects of a patient’s condition and experience. The purpose of this project is to make the IMPOWR CDE data more FAIR (Findable, Accessible, Interoperable, Reusable) by building a tool that will automate the mapping/conversion of HEAL-related data to the Observational Medical Outcomes Partnership data model that allows for systematic analysis of data from different databases. Upon completion, this tool would be shared with the HEAL research community as a new resource to enable broader harmonization and secondary data analysis.
1U01DA057862-01
Development of PPL-138, a Novel Mixed NOP/Mu Partial Agonist for Treatment of Cocaine Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA PHOENIX PHARMALABS, INC. TOLL, LAWRENCE R; LEVIN, FRANCES RUDNICK; LEVY, DANIEL Woodscross, UT 2022
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01)
NOFO Number: PAR-19-327
Summary:

Currently no medications are approved by the U.S. Food and Drug Administration for psychostimulant (cocaine and methamphetamine) use disorder. This project will develop a novel opioid molecule (PPL-138) that blocks cocaine and methamphetamine self-administration in animal models and that lacks rewarding properties that could lead to addiction. This research will conduct manufacturing and safety studies to prepare for Phase 1 clinical trials to determine safety in human patients.
1R01MH128904-01
Supporting Treatment Access and Recovery for Co-Occurring Opioid Use and Mental Health Disorders (STAR-COD) New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH University of Massachusetts Medical School SMELSON, DAVID A (contact); GONZALEZ, GERARDO ; LI, WENJUN ; OLMSTEAD, TODD ALDEN Worcester, MA 2021
NOFO Title: HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional)
NOFO Number: RFA-MH-21-145
Summary:

Opioid use disproportionally affects people with co-occurring mental health disorders. Although medication for opioid use disorder (MOUD) is the gold standard of care, engagement rates are low. Also, it is unclear whether addition of one or more behavioral interventions improves outcomes of MOUD treatment, particularly in patients with co-occurring mental health disorders. This project evaluates the effectiveness of the “Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION)” intervention—a multi-component, cross-disciplinary, team-based treatment approach that combines three evidence-based practices with MOUD—in people with co-occurring mental health disorders. The 4-year, five-arm, randomized controlled clinical trial will determine the therapeutic benefit of adding MISSION to MOUD and identify the MISSION components that yield the largest clinical improvement and offer the greatest return on investment.
3R01MH112138-03S3
A SYSTEM OF SAFETY (SOS): PREVENTING SUICIDE THROUGH HEALTHCARE SYSTEM TRANSFORMATION New Strategies to Prevent and Treat Opioid Addiction NIMH University of Massachusetts Medical School, Worcester BOUDREAUX, EDWIN D; KIEFE, CATARINA I. WORCESTER, MA 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The System of Safety (SOS) represents an opportunity to study the implementation of best practice suicide-related care processes that embody the Zero Suicide Essential Elements of Care across emergency departments, inpatient medical and behavioral health units, and primary care clinics associated with a large healthcare system. This effectiveness trial will use a stepped wedge design across a total of 39 clinical units. Aim 1 will measure suicide risk screening and screening's impact on risk identification. Aim 2 will measure the effective implementation of clinician-administered interventions, such as safety planning with means restriction counseling, on suicide, suicide attempts, and suicide-related acute healthcare. Exploratory aims will examine mechanisms of action, moderators, economics, and population effects of the intervention. This study's innovative approach positions it for a significant impact on the fields of suicide prevention, CQI, and effectiveness trial design and analysis.
3R01MH112138-05S1
Evaluating opioids and suicide prevention in health care settings through the System of Safety New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH UNIV OF MASSACHUSETTS MED SCH WORCESTER BOUDREAUX, EDWIN D; KIEFE, CATARINA I Worcester, MA 2020
NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

The project will apply natural language processing to a rich repository of suicide and other clinical electronic health record and vital statistics to detect opioid problem-related encounters in order to (1) explore the relation between suicide risk and opioid misuse and (2) test whether a Zero Suicide model?s intervention effect is moderated by opioid misuse and whether it can also help to reduce opioid-related harm. First, the team will extract opioid-related EHR data using a combination of diagnostic codes and natural language processing, validated by structured manual chart review using a standardized procedure. Next, they will analyze the interplay between suicide risk and opioid problems in encounters and patients within the repository. Third, they will assess the effect of Zero Suicide implementation on prospective fatal and non-fatal suicidal behavior in patients with an opioid problem and examine whether the implementation had an effect on the incidence of opioid-related outcomes, including intentional overdose.