Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s) Sort descending	Investigator(s)	Location(s)	Year Awarded
3UG1DA013035-18S4 Show Summary	Ancillary Study of the Adoption and Sustainability of ED-Initiated Buprenorphine	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	ROTROSEN, JOHN P; NUNES, EDWARD V.	New York, NY	2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) NOFO Number: PA-18-591 Summary: For many reasons, the emergency department (ED) is a critical venue to initiate opioid use disorder (OUD) interventions. ED patients have a disproportionately high prevalence of substance use disorders and are at an elevated risk of overdose, and many do not access health care elsewhere. Despite this, OUD interventions are rarely initiated in EDs. The Emergency Department Connection to Care with Buprenorphine for Opioid Use Disorder study (CTN-0079) will assess the feasibility, acceptability and impact of introducing clinical protocols for screening for OUD, buprenorphine treatment initiation, and referral for ongoing treatment in ED settings with high need, limited resources and different staffing structures. This extension study will use the existing infrastructure to evaluate the adoption and sustainability of the clinical protocols introduced at each of the study sites and to identify factors influencing their diffusion and effectiveness.
3UG1DA013035-18S5 Show Summary	Individual Level Predictive Modeling of Opioid Use Disorder Treatment Outcome	Translation of Research to Practice for the Treatment of Opioid Addiction	Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	ROTROSEN, JOHN P; NUNES, EDWARD V.	New York, NY	2019
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.
1U01DA055338-01 Show Summary	8/24 The Healthy Brain and Child Development National Consortium	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	THOMASON, MORIAH E (contact); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE	New York, NY	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-020 Summary: The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country and include racial and ethnic minorities of varying economic levels.
1U01DA047982-01 Show Summary	Long-acting buprenorphine vs. naltrexone opioid treatments in CJS-involved adults	Translation of Research to Practice for the Treatment of Opioid Addiction	Justice Community Opioid Innovation Network (JCOIN)	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	LEE, JOSHUA D; FARABEE, DAVID J; MARSCH, LISA A; SCHWARTZ, ROBERT P; SPRINGER, SANDRA ANN; WADDELL, ELIZABETH NEEDHAM	New York, NY	2019
NOFO Title: HEAL Initiative: Justice Community Opioid Innovation Network (JCOIN) Clinical Research Centers (UG1 Clinical Trial Optional) NOFO Number: RFA-DA-19-025 Summary: This study will assess the implementation of an evidence-based treatment in correctional settings by comparing the effectiveness of two medications used to treat opioid use disorder—extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX)—among adults currently incarcerated in U.S. jails and prisons at five distinct trial sites. This study will allow providers, correctional and public health authorities, payers, and policymakers’ timely and relevant data to assess the effectiveness of these medications as potentially useful re-entry treatment options. Findings from this study have implications for expanding public safety and limiting the societal costs of heroin, fentanyl, and prescription opioid addictions.
1UG3DA048234-01 Show Summary	Development of a novel drug for treating opioid use disorder	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	NIRSUM LABORATORIES, INC.	TUSCHE, MICHAEL; SHAH, NIKEJ	New York, NY	2019
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: The ongoing epidemic of opioid use disorder (OUD), overdose, and death is unprecedented. Available pharmacologic therapies for OUD have failed to stem the tide, plagued by poor adherence and retention, the principal factors associated with relapse and treatment failure. More than 80 percent of individuals with OUD are untreated. More treatment options are needed. This proposal seeks to develop a better antagonist-based OUD pharmacotherapy for populations highly motivated to achieve abstinence, such as military personnel, criminal justice clients, and the currently employed. A series of novel and proprietary small molecules will be designed and synthesized to address the adherence problem by inducing effective opioid antagonism with a single injection lasting at least 2 months, and up to 4 months or more. The goal of this project is to advance to Phase 3 clinical trials toward FDA approval of our lead compound. If successful, this project could lead to a novel therapeutic with superior adherence and retention, resulting in a significant public health impact by reducing rates of relapse, overdose, and death.