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:

The U.S. is in the midst of a devastating opioid epidemic. Since 1999, the number of overdose (OD) deaths involving opioids has quadrupled. These trends are magnified among American Indians/Alaska Natives (AI/ANs) compared to other racial/ethnic groups. AI/ANs are second only to Whites in the rate of OD mortality (8/100,000 versus 12/100,000 deaths, respectively). Medications for opioid use disorder (OUD; i.e., methadone, buprenorphine and naltrexone) are considered the most effective treatment, reducing mortality and increasing abstinence and retention. However, numerous barriers limit the uptake of medications for OUD in tribal communities and within urban treatment settings serving AI/AN individuals. This is a two-phase formative research study to develop and test an implementation intervention for programs to provide medications to treat OUD specifically with AI/AN consumers. The objective of Phase I (12 months) is to develop a culturally centered implementation intervention to integrate medications for opioid use disorder (MOUD) into health care/addiction specialty settings. The objective of Phase II (24 months) is to conduct a preliminary test of the implementation intervention at four sites serving AI/AN communities. Community-based participatory research (CBPR) methods will be used throughout both phases. This study will help with decreasing stigma and increase the utilization of MOUD in health care settings that serve AI/AN populations.

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

People who use opioids in rural areas suffer worse health and less insurance coverage. The opioid problem in rural areas is of particular concern, as rural areas have higher overdose rates despite equivalent rates of OUD. This is because rural areas have a scant number of clinics and clinicians who provide medication treatment for OUD. Thus, people living in rural areas must travel long distances to access clinics that may or may not have expertise in providing treatment to patients with OUD. Telemedicine (TM) could efficiently increase capacity for delivery of buprenorphine in rural areas and may increase the number of patients receiving medication treatment and improve treatment retention and outcomes. While the development of medication treatments for opioid use disorder (MOUD) capacity in primary care settings with optimal/comprehensive services is desirable, the current opioid crisis with escalating overdose death rates in rural areas suggests a need to implement an efficient, cost-effective system of MOUD services that can be scaled up quickly. The use of a centralized and Medicare-covered TM vendor utilizing a developed methodology and established organizational infrastructure offers the great potential for a rapid rollout to increase access to MOUD and improve treatment retention in rural areas. This cluster randomized clinical trial with two phases will test expanded treatment access to improve retention on MOUD in highly affected rural areas. Phase I will include implementing telemedicine in a limited number of rural sites with varying levels of office-based opioid treatment (OBOT) to inform implementation strategies for the main trial, and Phase II will include evaluate comparative effectiveness between OBOT alone and OBOT + TM at 30 sites.

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:

This proposal aims to test the impact of an empirically derived implementation strategy—under real-world conditions and across multiple child service systems—on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT). The overarching goal of this proposal is to evaluate whether the integration of implementation fidelity (fidelity to the implementation process) with intervention fidelity (fidelity to the clinical intervention) can increase the probability that a new organizational site not only successfully adopts a program but develops the infrastructure to ensure it can sustain. This study will (a) evaluate the effect of stages of implementation completion coaching strategy (SIC-CS) on outcomes of program adoption and sustainment, (b) extend the SIC to include measurement of sustainment, and (c) examine cost and resource patterns most likely to yield sustainable programs.

NOFO Title: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis (R43/R44 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-019
Summary:

This project aims to demonstrate the safety and effectiveness of a novel treatment for opiate addiction using a technique called photobiomodulation, application of light to the forehead. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near-infrared mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that has been determined to have a more positive emotional valence. The study will examine differences in opioid cravings, anxiety, depression, and opioid use between participants receiving the treatment and those receiving a sham treatment. We will evaluate patients weekly for safety and efficacy for 3 weeks post-treatment. In Aim II, a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.

NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Methodology and Advanced Analytics Resource Center (U2C Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-023
Summary:

Many individuals with opioid use disorder (OUD) pass through the criminal justice system over the course of their life. Improved access to high-quality, evidence-based addiction treatment in justice settings will be critical to addressing the opioid crisis. Through the Justice Community Opioid Innovation Network (JCOIN), the National Institutes of Health will study approaches to increase high-quality care for people with opioid misuse and OUD in justice populations. The Methodology and Advanced Analytics Resource Center (MAARC) will provide data infrastructure support across the network using advanced methods that provide best-in-class data storage, management and security with added value to clinical trials through products of forecasting, rapid real-time assessments, explication and exploration of trial findings, and cost-effectiveness analysis.

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:

Office-based opioid treatment (OBOT) with buprenorphine/naloxone prevents overdose deaths. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for opioid use disorder (OUD) treatment in most U.S. counties. Mindfulness-based interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention while reducing rates of relapse and overdose deaths. Current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project proposes to adapt, refine, and compare the effectiveness of the 6-month Mindful Recovery OUD Care Continuum delivered within group-based opioid treatment (GBOT) versus standard GBOT alone.

NOFO Title: PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])
NOFO Number: PA-16-302
Summary:

Since 2002, persons with opioid use disorders who desire medication-assisted treatment can be treated with buprenorphine, which has been shown to be efficacious. Buprenorphine treatment can occur in any medical office-based setting, is prescribed by any physician who seeks to become waivered, and is taken by patients at home unsupervised. However, without visual confirmation of medication ingestion, providers remain unsure if patients divert part or all of their buprenorphine medication. This project will develop the technical and logistical workflow needed to implement a video-­based application, miDOT, for office-­based buprenorphine monitoring during the initial months of care, which will allow health care providers to monitor whether patients ingest the drug and adhere to treatment. The project will configure a video-based DOT platform, evaluate its effectiveness in securing medication ingestion and care retention for illicit opiate users, and solidify routes of sustainable commercial viability with commercial partners.

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

Justice-involved young adults are one of the highest-risk populations for the development of opioid use disorder (OUD) and other significant public health problems, but they usually lack access to evidence-based practices that could potentially prevent this trajectory. The risk of unintentional death and other deleterious outcomes and long-term costs for opioid misuse for young adults, their communities and society (costs estimated at more than $115 billion annually) make this a priority, with rural areas in need of the most attention and assistance. The overriding purpose of the proposed pilot study is to prevent the onset of OUD by improving young adult offenders’ access to evidence-based risk reduction interventions, like contingency management (CM), by testing whether officers in the adult probation and parole setting can deliver such an intervention to their young adult substance using probationers who have not yet developed OUD. The primary motivation for this pilot is the clear public health need for improving and expanding delivery of substance use risk reduction interventions for young adults in the justice system. The ultimate outcome would be prevention of OUD in this high-risk population.

NOFO Title: NIH Research Project Grant (Parent R01 Clinical Trial Required)
NOFO Number: PA-18-345
Summary:

There are currently no FDA-approved treatments for cocaine use disorder (CUD) or co-occurring substance use disorder. High relapse rates pose a major obstacle to treatment, and this is due in part to the way that high drug cravings reduce individuals’ cognitive flexibility in situations where they are stressed or exposed to drug-related cues. These effects appear to be stronger in women with CUD than in men. Building on preliminary data that a drug called Guanfacine reverses these effects in women, but not in men, this 3-year pilot clinical study will test whether Guanfacine will reduce cocaine use and increase abstinence and will use laboratory challenges to determine whether it reduces cravings and enhances cognitive flexibility in stressful or drug-cue-related situations.

NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-18-573
Summary:

Adolescents in the juvenile justice system demonstrate very high rates of tobacco, alcohol, and other drug use (ATOD), with rates that are estimated to be three times higher than non-justice-involved youth. Substance-abusing youth are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide, as well as detrimental effects on neural development related to substance use. This project aims to adapt and test the feasibility and efficacy of a smartphone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use. The program, entitled Rewire, is based on the primary substance use cessation components tested in previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation, and applies a mindfulness approach as the guiding framework for the intervention.

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.

NOFO Title: NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
NOFO Number: PA-18-489
Summary:

This project aims to develop a novel abuse deterrent formulation (ADF) that will be uniquely designed to prevent abuse of the prescription pill. The study will focus on the development of the ADF with design aspects specifically focused on abuse through insufflation, smoking, injection, and taking multiple pills. The study will also validate the design by putting the pill through a rigorous test following the procedures outlined by the FDA Abuse-Deterrent-Opioids-Evaluation and Labeling guidelines. The study could result in the development of a novel ADF that will be resistant to a wide range of tampering, resulting in a safer formulation and pill design.