Funded Projects

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:

The first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids.

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:

Neonatal Opioid Withdrawal Syndrome (NOWS) affects a growing number of neonates each year due to the ongoing opioid epidemic ravaging the United States. Complex neurobehavioral observation of newborns is the primary modality used. It is subjective and time-consuming by nature, requires significant expertise, and can lead to delays in treatment. The goal of this project is to develop an innovative, low-cost, non-invasive, and easy-to-use brain monitor to objectively assess the severity of withdrawal symptoms in newborns exposed to opioids and provide evidence-based decision support to care providers to improve both short- and long-term developmental outcomes. This device, referred to as NeoGUARD, is based on the continuous, automated, and real-time monitoring of brain function to detect EEG abnormalities shown to be related to NOWS and determine severity to guide pharmacological intervention. This study will focus on the initial prototyping and refinement of the hardware and software, as well as initial evaluations of its use.

NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3)
NOFO Number: PAR-20-092​
Summary:

Naltrexone is the only medication approved by the U.S. Food and Drug Administration to prevent relapse from opioid use disorder. This medication remains underused because it must be injected into muscle by a nurse and is relatively expensive. This project will develop and test a novel naltrexone skin patch that is easier to use, more comfortable, and inexpensive.

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

Hospital inpatient stays due to opioid-related health problems are a reachable moment for increasing access to treatment with medications for opioid use disorder (MOUD). Hospitalized patients with opioid use disorder (OUD) are at particularly high risk for morbidity, mortality, and high medical costs in the U.S. This study will substantially inform the care management of OUD in hospitalized patients. The project includes a comparative effectiveness research trial and an implementation research trial, which will lead to models of broad dissemination for treatment approaches to this largely unaddressed population. They will examine whether (1) in hospitals with addiction medicine consultation services, hospital-initiated extended-release buprenorphine (XR-BUP), compared with other OUD medications, results in increased engagement in treatment with MOUD following hospital discharge and (2) training hospitals without such consultation services on best practices for initiating MOUD using consultation service hubs improves medication uptake in hospitals and increased MOUD treatment engagement following discharge.

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

The opioid epidemic continues unabated in the United States, and despite the rapid expansion of this crisis, the nature of the risk factors that contribute to opioid misuse remain poorly understood compared with other substances of abuse. The goal of this project is to examine cannabis use and cannabis identification measures as risk factors for opioid misuse while also developing and evaluating novel implicit measures of opioid associations as risk factors for opioid misuse among an at-risk sample of adolescents. Findings from the proposed research are intended to improve the prediction of opioid misuse among adolescents and to potentially identify novel targets for prevention and intervention strategies that aim to combat the opioid epidemic.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

Increasing primary care clinician intention and behavior to obtain waivers to prescribe buprenorphine for treatment of opioid use disorder and increase use of the Opioid Wizard, a clinical decision support tool, has potential for patient benefit. This supplement will provide support to evaluate a training tool as an intervention to reduce stigma in primary care clinics by integrating a stigma reduction training component into the Opioid Wizard training at multiple sites of the NIDA Clinical Trial Network. Primary care providers will be randomized to novel stigma reduction training, grounded in stigma science, or an attention-control training to determine whether stigma reduction training reduces provider stigma, increases intention to apply for a waiver to prescribe buprenorphine, and ultimately increase the likelihood that providers use Opioid Wizard. The proposed supplement will utilize the randomized controlled trial design embedded in the larger multisite trial to evaluate the Opioid Wizard tool to help primary care clinicians identify, diagnose, and treat patients with opioid use disorder while evaluating the effect of the stigma reduction training.

NOFO Title: HEAL Initiative: Harm Reduction Policies, Practices, and Modes of Delivery for Persons with Substance Use Disorders (R01 Clinical Trial Optional)
NOFO Number: RFA-DA-22-046
Summary:

Research is needed to better understand how to make life-saving harm reduction services more accessible to populations that are hard to reach. This project will identify the physical and psychological factors that make harm reduction services most effective. The findings will then be used to inform the development, implementation, and testing of an innovative strategy consisting of several internet- and smartphone-based tools designed to improve access to harm reduction services for people who are hard to reach. 

NOFO Title: Behavioral & Integrative Treatment Development Program (R34)
NOFO Number: PA-16-073
Summary:

The increased risk of maternal, obstetric, and newborn morbidity and mortality associated with perinatal prescription opioid (PO) misuse and opioid use disorder (OUD) is well established. Despite clear advances in maternal, fetal, and newborn health with treatment of perinatal opioid misuse and OUD, much work remains. Preliminary data has demonstrated significant reductions in opioid misuse as a result of our Cognitive Behavioral Therapy (CBT) program for pain combined with shared decision making for medication management for pregnant women misusing POs or with OUD (including heroin). However, access to the program is still limited and several obstacles to its expansion remain. This proposal will fill this critical gap by converting their CBT intervention from in-person sessions to a web-based interface. The proposed research will result in a critical advance in the management of opioid use and abuse during pregnancy and prevent both the acute and long-term risks associated with pre- and perinatal PO misuse and OUD, including overdose and death.

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

A persistent problem in the dissemination of medications for opioid use disorder (MOUD) is patient dropout, and matching patients to suitable medication early has the potential to minimize dropout. The overall objective of this secondary data analysis study is to develop and disseminate individual level risk prediction models using harmonized data collected from three multi-site clinical trials from the CTN, in order to predict specific clinical outcomes (e.g., dropout, relapse) for patients treated with MOUD, including methadone, buprenorphine or extended-release depot naltrexone. The relative importance of predictors in the best predictive models will be estimated, which may facilitate refinement of common data elements for future OUD studies. The comprehensive, harmonized database of treatment data created in this study can be used for future secondary data analysis studies and will provide a replicable data pipeline to process and validate OUD data in future protocols.

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:

Infants exposed to opioids in the womb may suffer from neonatal opioid withdrawal syndrome (NOWS). They experience symptoms such as excessive crying, irritability, rapid breathing, elevated heart rates, tremors, and sometimes seizures. There is no accepted standard treatment for NOWS; infants are treated with pharmacological (opioid administration and gradual weaning) and nonpharmacological measures. Nonpharmacological care such as swaddling, rocking, frequent feedings, and skin contact, are time consuming, placing a substantial burden on hospitals with limited resources. Prapela, Inc. previously developed a hospital bassinette pad that, using stochastic vibrotactile stimulation (SVS) technology, very gently rocks infants with NOWS to reduce irritability and other symptoms without disturbing sleep patterns. This project will conduct an additional clinical study to determine the SVS bassinette pad’s efficacy in reducing breathing and heart rate, its safety, and its acceptability with clinical staff and parents caring for infants with NOWS.

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. The MIRHIQL Resource Center will provide infrastructure support for the network as well as create a risk-benefit decision tool to help providers determine when opioids should be continued as prescribed, tapered, or tapered/discontinued. The center will first develop and validate a clinical definition for individuals who take long-term opioids, then study long-term outcomes in participants who receive treatment in primary care settings. This research will partner with many groups including individuals with lived experience, community health care providers who treat such individuals, research scientists, bioethicists, and professional societies

NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-025
Summary:

Individuals who have been previously incarcerated have a significantly higher risk of dying from opioid overdose, particularly in the first two weeks after release. Providing medication for opioid use disorder (MOUD) to individuals on probation or parole decreases the rate of relapse and recidivism, and increases retention in substance abuse treatment. This study will test a systems-change approach for increasing use of MOUD across a network of seven probation and parole sites to improve linkage to the continuum of evidence-based care for justice-involved individuals. Implementation outcomes include program acceptability, adoption, penetration, sustainability, and costs. Client-level effectiveness outcomes include retention, satisfaction, opioid use, opioid overdoses, recidivism, linkage to OUD treatment, and utilization of recovery services. Targeting the intersection of justice and community-based care has substantial potential for addressing the opioid crisis.