Funded Projects

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

This supplement supports the goals of the current award, “An Evaluation of the National Zero Suicide Model Across Learning Healthcare Systems” (U01MH114087). Safety planning is a highly recommended practice within the Zero Suicide framework, but little is known about the effectiveness of the individual elements that can make up a safety plan, such as lethal means assessment, identification of supportive contacts, coping skills, warning signs, and sources of distraction. All of the documentation lives in text-based clinical narratives. This supplement will support development of new metrics using natural language processing to determine baseline rates, from which we can quantify the change in safety planning and lethal means assessment practice longitudinally after implementation of new safety planning templates using our Zero Suicide main award.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

New Hampshire can anticipate as many as 1,000 infants born with prenatal opioid exposure each year. Pain management is complicated for pregnant women with opioid use disorder (OUD), and undermanagement of pain is a strong risk factor for relapse. Contemplative interventions, such as yoga and mindfulness, may reduce risks for relapse for pregnant and parenting women with OUD. This project represents a partnership with New Hampshire stakeholders to develop and pilot evaluation of a trauma-informed yoga and mindfulness relapse prevention intervention (Mindful Moms in Recovery: MMORE). It aims to: 1) identify needs and areas of adaptation of trauma-informed yoga and mindfulness-based relapse prevention protocols through formative work with pregnant and parenting woman; 2) develop an integrated 10-session intervention protocol with iterative feedback from client stakeholders; and 3) evaluate feasibility, acceptability, and efficacy trends of MMORE in a pre-post pilot with pregnant women.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: RFA-DA-19-002
Summary:

This project proposes to develop novel Gpr151 antagonists to facilitate long-term abstinence in opioid-dependent individuals. Gpr151 is an orphan G-protein coupled receptor that is expressed almost exclusively in the medial habenula and co-localizes with ?-opioid receptors to regulate the inhibitory effects of opioids on habenular neurons. Mice with a null mutation in Gpr151 (Gpr151-/- mice) are resistant to the stimulant and rewarding effects of opioids and self-administer lower quantities of oxycodone. Based on this preliminary work, the study will seek to identify Gpr151 antagonists through a variety of methods and optimize them for potency, selectivity, drug metabolism, pharmacokinetics, and brain penetration properties. The study will evaluate effects of those with the most favorable drug-like physiochemical properties on electrophysiological responses of medial habenula to opioid drugs and assess the in vivo efficacy of these novel antagonists in wild-type and Gpr151-/- mice.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

Many individuals who receive medication-assisted therapy (MAT) leave treatment early and continue to struggle with opioid use disorder (OUD), often within the context of poorly managed comorbid chronic pain. Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been examined in the OUD population receiving MAT. This study proposes to refine and adapt a psychosocial pain management intervention (PPMI) delivered by telephone for patients with OUD receiving MAT and then to conduct a randomized controlled trial of the intervention in patients receiving MAT to improve adherence and pain- and substance-related outcomes. The intervention uses elements of cognitive behavioral pain management interventions adapted specifically for patients with OUD receiving MAT. The new intervention will be compared to an enhanced usual care condition (EUC) in 100 patients.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Overcoming barriers to substance use (SU) screening and enrollment in SU care is central to decreasing justice-involved youth’s (JIY) negative HIV-related outcomes. This project proposes to embed HIV testing outreach workers from a youth-focused medical and HIV treatment program into an alternative sentencing program (ASP) to deliver a new service delivery model (Link2CARE) that integrates evidenced-based protocols for JIY to promote HIV and sexually transmitted infection (STI) testing and HIV and SU risk screening, and provide on-site intervention and cross-system linkage to HIV, STI, and SU care. We propose to determine the efficacy of Link2CARE delivered by health staff embedded within the ASP on HIV, STI, and SU outcomes; to determine the influence of theoretically based intervention mechanisms of change on the proposed HIV and SU outcomes; and to describe Link2CARE implementation and elucidate the system/organizational-, staff-, and youth-level factors that influence implementation of Link2CARE in an ASP.

NOFO Title: NIH-DoD-VA Pain Management Collaboratory - Coordinating Center (U24)
NOFO Number: RFA-AT-17-002
Summary:

The Pain Management Collaboratory Coordinating Center (PMC3) will 1) provide national leadership and technical expertise in all aspects of research supporting the design and execution of high-impact demonstration projects that conduct cost-effective, large-scale, pragmatic clinical trials on non- pharmacological approaches for pain management and other comorbid conditions in veteran or military health care systems and 2) make data, tools, best practices, and resources from these and other projects available to facilitate research partnerships in VA and DoD health systems. The aims are to: 1) develop, adapt, and adopt technical policy guidelines and best practices for the effective design and conduct of pragmatic trials; 2) work collaboratively with and provide operational, technical, design, and other support to demonstration project teams to develop, initiate, and implement a research protocol; and 3) disseminate NIH–DoD–VA Pain Management Collaboratory–endorsed policies and best practices and lessons learned within military and veteran health care systems.

NOFO Title: Translational Research on Interventions for Adolescents in the Legal System: TRIALS (U01)
NOFO Number: RFA-DA-13-009
Summary:

Less than half of youth in the juvenile justice system who meet the criteria for substance use disorders (SUD) have ever received treatment, and less than one third of those received treatment while under community or correctional supervision. SUDs during adolescence can lead to significantly longer periods of substance use, more severe offending, and penetration in the justice system. The Translational Research on Interventions for Adolescents in the Legal System (TRIALS) cooperative is intended to develop and test implementation strategies and associated measures to improve the continuum of substance abuse and HIV prevention and treatment services delivered to youth under juvenile justice supervision.

NOFO Title: Opioid Use Disorder in Pregnancy (R01)
NOFO Number: RFA-HD-18-036
Summary:

Neonatal abstinence syndrome (NAS) rates have increased since 2000. To determine multifactorial genetic, psychosocial predictors of opioid-related maternal and infant outcomes using rigorous prospective longitudinal design, innovative combinatorial pharmacogenetic approach, fetal MRI, and neonatal brain resting state functional MRI analysis, we hypothesize that a combination of maternal and infant genetic profiles, maternal psychosocial factors, maternal opioid treatment response, fetal and neonatal neurodevelopment, and NAS treatment will affect maternal and childhood outcomes with prenatal opioid exposure. The specific aims are to (1) Identify high-risk genetic profiles and psychosocial factors in pregnant women with opioid use disorder (OUD) and predisposing to poor maternal opioid maintenance treatment outcomes; (2) Determine maternal-infant genetic profiles and maternal opioid treatment factors predicting adverse fetal development, severity of NAS, and neonatal brain function; and (3) Develop predictive models for maternal opioid relapse and poor long-term neurodevelopmental outcomes in children with in utero opioid exposure.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Over 30% of adults aged 65 years and older in the United States suffer from osteoarthritis (OA). Opioid analgesics are often used for patients with moderate to severe symptomatic OA. When non-pharmacologic and pharmacologic treatments are not effective, patients with severe OA may undergo total joint replacement (TJR). Our primary objectives are to evaluate patterns of opioid use before and after TJR and to assess the effect of opioid use patterns on clinical outcomes and safety events in a large U.S. population–based cohort of OA patients. The specific aims are to: 1) identify predictors of persistent opioid use and opioid dose escalation in patients after TJR for hip or knee OA and 2) evaluate effects of opioid use patterns on short- and long-term clinical outcomes and safety following TJR. The results of this study will provide guidance on surgical risk stratification and pain management of patients before and after TJR.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The goal of this proposal is to launch an innovative, multi-modal neuroimaging program that will investigate the longitudinal trajectory of the neurodevelopment of irritability across the preschool period. Differentiating clinically salient irritability from developmentally normative temperamental variation has proven to be a difficult task. This is made even more challenging during the preschool period, when irritability has hit its normative peak and measuring neurodevelopment is impeded by methodological constraints. This research will (1) identify specific biomarkers underlying preschool vulnerability for psychopathology by examining neural maturation in executive function as a predictor for clinical outcome; and (2) examine how the parenting environment moderates this vulnerability, with the overarching objective of identifying aberrant irritable trajectories as the foundation for future brain-based behavioral intervention. Primary analyses will (1) probe underlying executive function as a predictor of clinical outcome; and (2) examine parent-child neural synchrony as a predictor of executive function maturation.

NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002
Summary:

MAT is the most effective intervention for opioid use disorder (OUD), and methadone maintenance treatment (MMT) is the most commonly prescribed MAT; however, approximately half of people who begin MMT discontinue within a year, and half of people retained in MMT have an opioid relapse within six months. Chronic pain, affecting most people on MMT, could be contributing to relapse in this group. Novel behavioral interventions that address both chronic pain and opioid relapse among people on MAT are needed. Mindfulness Oriented Recovery Enhancement (MORE) was recently developed to treat both pain and opioid misuse. MORE is a group intervention that combines training in mindfulness, cognitive reappraisal, and positive emotion regulation skills to target the dysfunctional cognitive, affective, and behavioral pathways that lead to opioid use relapse. The objective of this proposal is to examine the impact of MORE on opioid relapse and chronic pain among individuals receiving MMT.

NOFO Title: Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR)(U54)
NOFO Number: PAR-14-303
Summary:

Mortality rates in Appalachia have progressively increased over recent years, in contrast to decreasing mortality rates observed in the remainder of the U.S. The West Virginia Clinical and Translational Science Institute (WVCTSI) was created in 2012 through the initial Clinical and Translational Research (CTR) award and has subsequently formed a well-connected, statewide research network, creating the infrastructure to address the substantial health disparities that exist in West Virginia. WVCTSI is now well positioned to attain the goals of this renewal application that include: 1) building sustainable research infrastructure that substantively contributes to improving West Virginia health outcomes by 2022; 2) recruiting the next generation of clinician scientists and translational researchers that excel in team science and are positioned for long-term success; and 3) actively engaging with multiple stakeholders that include communities, medical providers, and policy makers to drive research that improves the health of West Virginians.

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The parent U19, “Southwest Hub for American Indian Youth Suicide Prevention,” builds capacity among local tribal governments, investigators, interventionists, and service providers across three Southwestern states to: 1) identify at-risk youth and gather robust local data through surveillance; 2) provide regular monitoring and brief interventions to close gaps in continuity of care; and 3) convene regularly for shared learning, policy development, and dissemination of best practices. The parent U19 includes an innovative SMART trial study design. The purpose of this supplement is to gather data on opioid use. Our supplement aims are to: 1) expand suicide surveillance in the Southwest Hub to include opioid use as a potential precipitant, facilitator, and risk factor for subsequent suicidal behavior; 2) explore community beliefs about correlates of risk, protective factors, and behavior functions of opioid abuse in Native American youth; and 3) examine opioid use among SMART trial participants.