Funded Projects

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

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

Fentanyl and its analogs are synthetic opioids that are 100 to 10,000 times more potent than morphine. Overdose from these opioids is extremely dangerous due to their ultra-potency and longer half-life than naloxone, the front-line treatment for fentanyl overdose. This research study will develop novel mu opioid receptor antagonists that bind to the same receptor as the opioid drugs and specifically counteract fentanyl and its analogs, thereby reversing the drugs’ acute toxicity more effectively and with fewer side effects than current treatments. The researchers will characterize novel fentanyl derivatives, identify promising compounds, and pursue preclinical development of these compounds as novel reversal agents against the acute toxicity of fentanyl. The goal is to file an Investigational New Drug application with the U.S. Food and Drug Administration.

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

There is a significant treatment gap between patients diagnosed with OUD and those who seek treatment, and only a small proportion of those seeking treatment receive MOUD. Primary care is the most common point of health care contact in the U.S. and is an important venue to address stigma, improve access to treatment and improve quality of care. Over the past decade, electronic health record (EHR)-linked Web-based point-of-care clinical decision support (CDS) systems designed to improve quality of chronic disease care have become increasingly sophisticated and successful. A Web-based and EHR-integrated OUD CDS system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD was developed and piloted. This project will implement the OUD clinical decision support system in three large diverse health care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). The project will evaluate the impact of OUD CDS on practice process measures and patient outcomes. The study will also prepare for scalability and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance and assessing the short-term cost impacts of the OUD-CDS.

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1 Clinical Trial Optional)
NOFO Number: RFA-DA-19-008
Summary:

The Great Lakes Node (GLN) of the NIDA-supported Drug Abuse Clinical Trials Network (CTN) will serve as a vital Midwestern hub for the CTN and expand on the success of the CTN approach. The GLN aims include (1) identify substance misuse research and intervention protocols focused on systems-based practice; (2) establish a digital and computation health core for studies in mHealth, eHealth, artificial intelligence, natural language processing, and telehealth interventions; (3) bring substantial expertise with youth/adolescent health and seniors/aging to examine prevention strategies to mitigate these life-course pathways; (4) support work on opioid misuse that focuses on health disparities, including socioeconomic, geographic, sexual orientation, and gender identity; (5) leverage experience in professional education and practice-based learning to test the impact of professional education on opioid and substance use treatment; and (6) expand the pipeline of early investigators interested in substance misuse research.

NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

According to SAMHSA’s 2017 National Survey on Drug Use and Health (NSDUH), 11.4 million persons in the U.S. report past-year opioid misuse; out of them, only 2.1 million individuals met criteria for an OUD. Very little is known about efficacious interventions for those who do not meet criteria for moderate/severe OUD (i.e., subthreshold OUD). The prevalence of subthreshold OUD in primary care settings is 5 percent to 10 percent, with higher rates (21 percent to 29 percent) among those receiving prescribed opioids. Although they are at high risk of developing moderate/severe OUD and/or dying from an overdose, little or no empirical evidence exists for pragmatic prevention interventions that can be adopted at integrated general medical settings. To study the efficacy of prevention interventions to arrest the progression from risky opioid use, researchers will test the efficacy of a STOP intervention in primary care settings. STOP adopts an early intervention approach, based on a collaborative care model to prevent progression to moderate/severe OUD, and consists of a practice-embedded nurse care manager who provides patient education and supports the primary care provider (PCP) in engaging, monitoring and guiding patients who have risky opioid use; brief advice delivered to patients by their PCP; and phone counseling of patients by behavioral health providers to motivate and support behavior change. Researchers will determine whether STOP reduces risky opioid use and examine the impact of STOP on progression to moderate/severe OUD, overdose risk behavior and overdose events in adults with risky use of illicit or prescription opioids.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

The goal of this project is to discover potential targets for emergency department-based interventions that could enhance access to addiction treatment among Black and Latino individuals, who face significant disparities in access to ongoing addiction treatment. Through qualitative interviews with Black, Latino, and non-Latino White patients receiving emergency department-initiated buprenorphine, the research will identify patterns of barriers and facilitators for continuation of opioid use disorder treatment outside of the emergency department through a referral. The study will also evaluate differences in factors previously identified as predictors of worse treatment outcomes in these patient groups, including opioid overdose, polysubstance use, major depressive disorder, and stigma.

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 veterans have lower access to opioid use disorder (OUD) pharmacotherapy and need an effective transition from the justice system to the Department of Veterans Affairs (VA) and community health care systems to improve drug addiction treatment and outcomes. We will quantitatively evaluate patient and facility characteristics associated with differences in receipt of OUD pharmacotherapy among justice-involved veterans compared with non-justice-involved veterans and within-facility changes over time; qualitatively identify drivers of higher or lower access to OUD pharmacotherapy among justice-involved veterans compared with other veterans with OUD at the same facility; evaluate stakeholders’ perceptions of factors that explain within-facility changes in access to OUD pharmacotherapy over time; and develop and conduct a formative evaluation of implementation strategies to improve access to OUD pharmacotherapy. Results will be used to design and select implementation strategies that address identified barriers to improve access to OUD pharmacotherapy for justice-involved veterans.

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

Many opioid harm reduction services are designed and implemented to serve urban populations in traditional centers of opioid use and leave rural patients underserved. The proposed project seeks to demonstrate improved MAT participation, naloxone distribution, and syringe support services (SSPs) among justice-involved persons with opioid use disorders, and thus improve health and criminal justice outcomes across diverse urban and rural settings in Illinois. Reducing Opioid Mortality in Illinois (ROMI) is a multi-site trial that will be carried out using a hub-and-spoke model, with centralized long-standing social services infrastructure at the Community Outreach Intervention Projects (COIP) hosted at the University of Illinois at Chicago. COIP provides case management/transition of care services to justice-involved opioid users, extending resources and technical assistance to less-populated rural areas hardest hit by the opioid epidemic.

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:

The current overdose epidemic is being fueled by widespread, non-medical use of opioids prescribed by mostly well-meaning physicians who often lack adequate training on how to properly initiate, monitor, and discontinue opioid therapy. It is very difficult for physicians to fully assess a new patient?s risk of substance misuse and possible future overdose in the limited amount of time of a typical evaluation. The Care Continuity Program (CCP) is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. The CCP tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance-driven protocol. The results are instantly transmitted to the prescriber?s electronic health records (EHR), mitigating the prescriber?s civil and criminal liabilities. The study aims to validate the protocol and delivery system of the CCP by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings. If successful, this project can significantly expand the benefits of CCP to even a broader network of providers and help mitigate the impact of the opioid crisis

NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.

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

The sodium channel NaV1.8 is a promising target for the development of effective, non-addictive pain medications. Recent evidence from clinical studies indicates that medications that target NaV1.8 are effective at managing postoperative, neuropathic, and inflammatory pain, but with side effects and prohibitively high cost. This project will test the safety and compatibility in the body of an NaV1.8-targeted molecule, toward developing an effective, non-addictive, once daily oral medication for the treatment of acute postsurgical pain and chronic neuropathic. 

NOFO Title: HEAL Initiative: Coordinating Center to Support NIDA Preventing Opioid Use Disorder in Older Adolescents and Young Adults (ages 16–30) Initiative (U24 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-034
Summary:

The Coordinating Center (CC) will provide centralized logistical support and facilitate communication and coordination of activities across the cooperative. The CC will provide scientific leadership, which will include providing scientific expertise in the areas of implementation research and economic evaluation. The CC will establish an infrastructure for cross-site data collection, management, harmonization, and data sharing and provide expert methodological and statistical consultation.

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

This study will (1) test pharmacologic and behavioral 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.