Funded Projects

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Project #	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s) Sort ascending	Year Awarded
1R21DA048074-01 Show Summary	Prescription Opioid Formulation to Deter Extraction, Injection, Insufflation, and Smoking	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	PURDUE UNIVERSITY	Solorio, Luis	West Lafayette, IN	2019
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.
1UG3DA048774-01 Show Summary	Injectable naltrexone 2-month depot formulations	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	PURDUE UNIVERSITY	PARK, KINAM	West Lafayette, IN	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: Naltrexone (NTX) has been proven as an important, safe, and effective therapy in helping patients overcome opioid addition and in preventing overdose. Unfortunately, the therapeutic potential of NTX has been blunted by poor adherence. To combat this issue, a system must be developed to deliver NTX for longer durations than are currently available with a more patient-friendly format. The goal of this research is to optimize and scale up our laboratory PLGA-based microparticle formulations of NTX delivery (either 2 months or 7–10 days) and bridge it to a Phase 1 clinical trial. This innovation will result in a more patient-friendly format consisting of less painful injections and improved release kinetics. PLGA-based drug delivery systems have been used successfully in a number of small-molecule products and are the most widely utilized and studied biocompatible polymer systems in controlled release. Thus, the regulatory and development hurdles with the FDA will be lower than with other novel excipients or technologies. The significance of this research and product development is that the final outcome of this project will ultimately provide a new, readily viable, essential tool to help patients overcome opioid dependence.
1UG3DA059270-01 Show Summary	Long-Acting Biodegradable Buprenorphine Depots	Novel Therapeutic Options for Opioid Use Disorder and Overdose	Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose	NIDA	PURDUE UNIVERSITY	OTTE, ANDREW	West Lafayette, IN	2023
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional) NOFO Number: PAR-22-200 Summary: Buprenorphine is an effective treatment for opioid use disorder, but its use is limited due to the need for frequent dosing. This project will optimize the molecular features of an injectable, biodegradable, long-acting (3-month) buprenorphine implant that would not require surgical removal. The research aims to advance toward testing in human research participants.
3U10HD036801-21S1 Show Summary	MFMU HEAL Initiative Opportunity: Opioid Prescription Protocols at Discharge after cesarean delivery	Clinical Research in Pain Management	Pain Management Effectiveness Research Network (ERN)	NICHD	George Washington University	Clifton, Rebecca	Washington, DC	2019
NOFO Title: Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10) NOFO Number: RFA-HD-13-014 Summary: Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost universally used for post-cesarean analgesia management. Studies suggest that most women are prescribed more tablets at discharge than needed. These often go unused, providing an important reservoir contributing to the opioid crisis. Physicians struggle to prescribe and dose postoperative opioids appropriately while tackling the real needs of acute pain from surgery. Without literature to guide obstetric providers on appropriate amounts of opioids to prescribe upon discharge, actual prescription amounts nationally vary widely by up to 65 tablets. To improve post-cesarean opioid prescribing practices without compromising pain management, the study will test an individualized, patient-empowered approach for pain management and opioid prescription quantity. This is a noninferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge.
1R61DK135406-01 Show Summary	PAINED: Project Addressing Inequities in the Emergency Department	Clinical Research in Pain Management	Advancing Health Equity in Pain Management	NIDDK	Children's Research Institute	GOYAL, MONIKA KUMARI	Washington, DC	2022
NOFO Title: HEAL Initiative: Advancing Health Equity in Pain Management (R61/R33 Clinical Trial Required) NOFO Number: NS22-002 Summary: Clinician bias causes inequities in healthcare, and interventions are needed to mitigate and eradicate this bias. This project aims to develop and test the impact of two interventions on overcoming clinician implicit bias in the management of pain for children from ethnic minorities treated in the emergency department. The study will include pediatric patients from under-represented minority groups with pain from long-bone fractures or acute appendicitis who are cared for by racially and ethnically diverse caregivers. Researchers will use stakeholder-informed approaches to establish quality of care metrics and then use clinician audit and feedback as well as data from electronic health records to quantify evidence of bias.