Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1U24DA057612-01
WF DISC: Navigating Data Solutions for Chronic Pain and Opioid Use Disorder Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA WAKE FOREST UNIVERSITY HEALTH SCIENCES ADAMS, MEREDITH C B Winston-Salem, NC 2022
NOFO Title: HEAL Initiative: HEAL Data2Action Data Infrastructure Support Center (U24 Clinical Trial Optional)
NOFO Number: RFA-DA-22-052
Summary:

This project creates the HEAL Data2Action Data Infrastructure Support Center that will conduct research as well as support the HEAL Data2Action Innovation Projects with analytics and support for navigating electronic health records and other “big data” sources, as well as logistical processes related to privacy and ethics. The center will help plan for data collection and assessing outcomes, as well as provide data visualization efforts for various stakeholders. Key support mechanisms include courses, seminars, conferences, trainings, and on-demand technical assistance.
1R43DA049617-01
At-Home Virtual Reality Guided Imagery Intervention for Chronic Pain Cross-Cutting Research Small Business Programs NIDA LIMBIX HEALTH, INC. LEWIS, BENJAMIN (contact); RICHEIMER, STEVEN H Palo Alto, CA 2019
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:

Chronic pain affects more than 100 million adults in the United States, resulting in disability, loss of work productivity, and overall reductions in health, making chronic pain a major public health problem with an economic burden estimated at $560–635 billion annually. Opioids, the most frequently prescribed class of drugs to control pain, lack evidence supporting their long-term efficacy and carry a 15% to 26% risk of misuse and abuse among pain patients. Guided imagery (GI) is an effective non-pharmacological intervention for reducing pain, but its effectiveness is limited by patients’ imaging abilities. This project will develop and assess the feasibility of an at-home virtual reality system, Limbix VR Kit, to reduce chronic pain and opioid reliance, as well as improve other functional outcomes, by delivering an immersive GI experience.
2R44DA053078-02
Developing and Testing the Opioid Rapid Response System Cross-Cutting Research Small Business Programs NIDA REAL PREVENTION, LLC HECHT, MICHAEL (contact); CHOI, HYE JEONG Clifton, NJ 2023
NOFO Title: PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)
NOFO Number: PA-22-177
Summary:

Reversing an opioid overdose requires a rapid response not available through standard emergency procedures. The Opioid Rapid Response System recruits and trains citizen responders to reverse overdoses with naloxone. It uses widely disseminated smart phone apps linking responders to an overdose through the 911 system. This project will complete the development of this system, test how well it works to reverse an opioid overdose, and prepare to share it widely. 
1R43DA050349-01
A Novel Chemokine Receptor Antagonist to Block Opioid Reinforcement, Relapse and Physical Dependence Cross-Cutting Research Small Business Programs NIDA CREATIVE BIO-PEPTIDES, INC. RUFF, MICHAEL Potomac, MD 2019
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:

Current agonist treatments for opioid use disorder (OUD) are not adequate to address the opioid crisis and have abuse liability concerns. Chemokines (hormones of the immune system that mediate innate immune inflammation) enhance pain, reduce opioid analgesia, and promote drug-seeking behavior and addiction—giving them a central role at the crossroads of chronic pain and the opioid crisis. So blocking chemokines (rather than opioid receptors) provides an exciting and untested treatment opportunity for pain and OUD. This proposal will assess, in animal self-administration models that mimic human drug-taking, whether a chemokine antagonist peptide R103 reduces morphine intake, as well as if R103 will prevent or blunt naloxone-precipitated withdrawal signs in morphine-dependent rats and stop relapse.
1R61DA059168-01
The Use of Novel Linked Databases to Reduce Postoperative Opioid Use Among Patients Undergoing Inpatient Surgery Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA STANDFORD UNIVERSITY SUN, ERIC (contact); COLQUHOUN, DOUGLAS ALASTAIR Stanford, CA 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Older adults make up more than half of all surgical patients in the United States, putting them at risk for a range of harmful outcomes including misusing opioids, developing opioid use disorder (OUD), opioid overdose, and surgical complications. This project seeks to understand whether pre-surgery interventions can prevent harmful opioid-related outcomes. The research will combine data from a registry of electronic health records and from Medicare claims data to learn about the relationship between these interventions and opioid-related outcomes including persistent opioid use, OUD, and other harmful outcomes.
1R61DA059169-01
Leveraging Data to Action: Accelerating Emergency Department OUD Care by Improving Data Access and Infrastructure Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA YALE UNIVERSITY VENKATESH, ARJUN KRISHNA (contact); HAWK, KATHRYN; TAYLOR, RICHARD ANDREW New Haven, CO 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Emergency departments (EDs) are key settings for identifying and treating opioid use disorder (OUD), but EDs are underused for this purpose. This project aims to develop a data system that automates and integrates electronic health record and administrative data from EDs into the Clinical Emergency Department Registry, partnering with the American College of Emergency Physicians. The research will assess the digital readiness of ED systems before developing and deploying the enhanced ED OUD data infrastructure. This research aims to guide near-real time hospital quality improvement initiatives, toward development of a web-based, near-real time dashboard that can be used in EDs across the country.
1R43DA049684-01
Non-intrusive detection of temporary neurologic impairment by opioids Cross-Cutting Research Small Business Programs NIDA ZXEREX CORPORATION BESSERMAN, RICHARD Scottsdale, AZ 2019
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:

With the exception of the Breathalyzer for alcohol, there is currently no available technology that can immediately identify neurologic impairment related to the use of licit or illicit drugs. The presently available methods for detecting opioids—which rely upon analysis of urine, blood, saliva, or hair—are expensive, time-consuming to implement, and can take days to deliver actionable information to meet the “fitness-for-duty” concerns of employers as well as the needs for immediate detection of drug use in the drug rehabilitation and public safety fields. This project intends to develop a non-invasive means of identifying temporary neurological impairment from prescription opioids using analysis of involuntary eye movements. The resultant biometric signature of opioid impairment will be incorporated into Zverex’s existing product library of oculomotor biosignatures, such as marijuana impairment and fatigue.
1R01DA057686-01
Fast and Fine: NLP Methods for Near Real-Time and Fine-Grained Overdose Surveillance Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF KENTUCKY KAVULURU, VENKATA NAGA RAMAKANTH Lexington, KY 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Timely and accurate surveillance of fatal and non-fatal overdoses is necessary in light of the worsening overdose crisis, but data is rarely available in real-time. Tracking non-fatal overdoses is especially important because patients who overdose once are likely to experience additional and potentially fatal overdoses. This project aims to increase the quality and timeliness of non-fatal overdose data estimates by analyzing clinicians’ notes rather than clinical codes from emergency department and emergency medical services records. The datasets and models produced from this research will be used to build an interactive dashboard with up-to-date, county-level overdose-surveillance estimates for use by Kentucky first responders to aid in rapid allocation of resources.
1R43DA049623-01
Non-invasive Neuromodulation Device for Decreasing Withdrawal Symptoms and Craving during Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA THERANOVA, LLC JAASMA, MICHAEL San Francisco, CA 2019
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:

Opioid use disorder (OUD) can be lethal, with opioid overdose causing more than 115 deaths in the U.S. each day. Although medications are effective at reducing illicit opioid use and overdose deaths, it is well-established that withdrawal and craving are highest in the initial weeks, making this a high-risk period for treatment dropout, relapse, and overdose. Adjunct therapies that can reduce early opioid withdrawal and craving may improve retention in treatment with buprenorphine-naloxone, and recent research has shown that stimulation of a peripheral nerve significantly modulates withdrawal- and craving-related responses for opioids and other drugs. This project will test the effectiveness of the EMPOWER Neuromodulation System, a portable, non-invasive transcutaneous electrical nerve stimulation (TENS) device developed by TheraNova for the treatment of OUD.
2R44DA048689-02
Beacon-OUD: Behavioral Economic Screening Tool of Opioid Use Disorder (OUD) for Use in Clinical Practice Cross-Cutting Research Small Business Programs NIDA BEAM DIAGNOSTICS, INC. SNIDER, SARAH EMILY Roanoke, VA 2023
NOFO Title: PHS 2021-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-21-259
Summary:

Current clinical screening measures for opioid misuse are underused and susceptible to bias. This project will develop Beacon-OUD, a digital opioid misuse assessment. The tool generates an automated, standardized score, preventing potential judgements related to patient’s status and circumstances, limiting stigma. The research will further advance Beacon-OUD into a commercial product for use both as a stand-alone tool and as an electronic health record-integrated solution to encourage objective opioid misuse screening in large health care systems. 
1R43DA050358-01
A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders Cross-Cutting Research Small Business Programs NIDA MINDLIGHT, LLC SCHIFFER, FREDRIC (contact); TEICHER, MARTIN H Newton, MA 2019
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.
1R61DA059163-01
Supporting Data-Driven Decision-Making to Support Substance Use Service Expansion Policies and to Prevent Overdoses Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA CHESTNUT HEALTH SYSTEMS, INC. CRUDEN, GRACELYN Bloomington, IL 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Oregon ranks last in the United States for access to substance use services, having passed a novel ballot measure bringing unprecedented funding levels to expand services and decriminalize possession of personal amounts of substances. This project will develop and evaluate a strategy to inform development of the policy. Cross-sector participants (e.g., community service providers, law enforcement, advocates) will co-design protocols for linking and distributing substance use service data through reports, simulations, and dashboards. This research will test the usability of the developed products and their impact of DDS on service gaps, evidence-based decision-making, quality of evidence-based services, service recipient outcomes, and cross-sector collaboration. The research will also help state decision makers implement strategies for other substance use policies.
1R42DA049448-01
Reward-based technology to improve opioid use disorder treatment initiation after an ED visit Cross-Cutting Research Small Business Programs NIDA Q2I, LLC BOUDREAUX, EDWIN D Rindge, NH 2019
NOFO Title: Loyalty and Reward-Based Technologies to Increase Adherence to Substance Use Disorder Pharmacotherapies (R41/R42 - Clinical Trial Optional)
NOFO Number: RFA-DA-19-015
Summary:

Medication-assisted treatment (MAT) for opioid use disorder (OUD) is highly efficacious, but only a fraction of people with OUD access MAT, and treatment non-adherence is common and associated with poor outcomes. This project aims to increase rates of Suboxone (buprenorphine/naloxone) treatment initiation and adherence among OUD patients recruited from emergency and inpatient acute care by enhancing the Opioid Addiction Recovery Support (OARS)—an existing Q2i company technology—with a new evidence-based reward, contingency management (CM) function that allows for the automatic calculation, delivery, and redemption of rewards contingent on objective evidence of Suboxone initiation and adherence.
1R01DA057630-01
Predicting Fatal and Non-Fatal Overdose in Los Angeles County with Rapid Overdose Surveillance Dashboard to Target Street-Based Addiction Treatment and Harm Reduction Services Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA UNIVERSITY OF CALIFORNIA LOS ANGELES SHOVER, CHELSEA LEIGH (contact); GOODMAN, DAVID Los Angeles, CA 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Effective overdose prevention requires timely, location-specific data to efficiently direct resources and interventions as well as to inform healthcare policy. However, rarely is such information available, resulting in responses that are frequently too late. This project will partner with local government agencies from Los Angeles County, California, to rapidly acquire and analyze information in near real-time from multiple sources to identify overdose hotspots and determine overdose metrics. This information will be used to develop a publicly available Rapid Overdose Surveillance Los Angeles online dashboard with built-in analytics. The dashboard will help determine the scope and specifics of overdose and opioid use in Los Angeles County to help target response and guide mobile addiction treatment and harm reduction services.
1R44DA047866-01
NEONATAL OPIOID SCREENING USING APTAMERS AND COMPENSATED INTERFEROMETRY Cross-Cutting Research Small Business Programs NIDA Base Pair Biotechnologies, Inc. Jackson, George W PEARLAND, TX 2019
NOFO Title: PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
NOFO Number: PA-18-574
Summary:

Newborn Abstinence Syndrome, which results from maternal opioid drug use prior to birth, is a serious condition that affects approximately 6% of all neonates born today in the U.S. and which is increasing rapidly in incidence because of this epidemic. Availability of a rapid screening test that can be administered at the point of care to all neonates would allow for early intervention, reducing costs of treatment and reducing pain and suffering for this vulnerable and helpless patient population. Providing a platform to accurately monitor actual levels of these drugs and their metabolites in such patients would allow better-controlled use of these pain management treatments, personalized to the needs of the individual neonate, and would reduce the probability of addiction and resulting complications, which include deleterious neurological effects. The purpose of this FastTrack SBIR project is to expand upon preliminary results that a device can sensitively and accurately detect opioids and their primary urinary metabolites in one-microliter urine samples, in less than a minute after sample introduction into the device, and adapt the device into a point-of-care instrument for use in hospitals, clinics, and other venues in which such tests are likely to be deployed.
1R44DA049630-01
Opioid-Sparing pain management for Chronic Low Back Pain patients using TMC-CP01 - A VANISH (Virtual Autonomic Neuromodulation Induced Systemic Healing) based program Cross-Cutting Research Small Business Programs NIDA TAMADÉ, LLC TIEN, CELINE (contact); LUCAS, GALE ; MAHAJAN, AMAN Pasadena, CA 2019
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:

Opioids have been found to be ineffective for chronic lower back pain (CLBP), yet they are still commonly prescribed. TAMADÉ, LLC aims to leverage a novel and validated technology based on virtual reality (VR) to provide therapy to CLBP patients on a daily opioid dosage with an opioid-sparing pain management tool aiming to increase pain management efficacy and decrease health complications. The intervention uses VR to stimulate patients’ visual, auditory, and haptic fields in order to simultaneously distract and actively engage patients in biofeedback therapy, where patients consciously self-regulate their nervous system by paring down their sympathetic tone through exercises in controlling respiration and heart rate. The study will compare patients receiving the proposed VR-based intervention with a group receiving either just opioids or opioids with sham VR. All groups will receive the same opioid tapering guidelines.
3RM1DA055301-01S1
Integrative Treatment for Achieving Holistic Recovery from Comorbid Chronic Pain and Opioid Use Disorder Cross-Cutting Research Training the Next Generation of Researchers in HEAL NIDA UNIVERSITY OF NEW MEXICO WITKIEWITZ, KATIE A; PEARSON, MATTHEW RYAN Albuquerque, NM 2022
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; PA-21-071
Summary:

Few integrated treatments are available that simultaneously address the fundamental causes of chronic pain and opioid misuse/opioid use disorder and focus on well-being among individuals with chronic pain and opioid misuse/opioid use disorder. This research will inform development of patient-centered interventions that increase quality of life and engagement in valued activities, are culturally appropriate for use by diverse patient populations, and reduce stigma related to chronic pain and opioid misuse/opioid use disorder. The results of this project will be used to inform future research focused on developing mobile health treatments for individuals with chronic pain and opioid use disorder, and for developing culturally appropriate treatments for chronic pain and opioid use disorder in Hispanic/Latino individuals.
2R44DA050393-02
Evaluation of the Therapeutic Potential of Exclusive Antagonists of Extrasynaptic NMDA Receptors for the Treatment of Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA NEURANO BIOSCIENCE MOLOKANOVA, ELENA La Jolla, CA 2023
NOFO Title: Advancing Validated Drug Targets for Substance Use Disorders (R43/R44 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-023
Summary:

New and safe therapeutic targets for treating opioid use disorder are needed. One promising approach is to test drugs currently approved by the U.S. Food and Drug Administration that work independently of the body’s opioid system. The medication memantine targets N-methyl-D-aspartate (NMDA) receptors in the brain, which have been implicated in the development and maintenance of addiction. This project will study a miniature version of multiple memantine molecules bound together that attaches only to NMDA receptors that are not within nerve connections. The research will evaluate the safety, misuse potential, and effectiveness of this molecular assembly in preclinical models. 
3R44DA044053-02S1
DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE Cross-Cutting Research Small Business Programs NIDA emocha Mobile Health, Inc. Seiguer, Sebastian Owings Mills, MD 2019
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.
3R44DA044053-03S1
DEVELOPMENT AND EVALUATION OF VIDEO-BASED DIRECTLY OBSERVED THERAPY FOR OFFICE-BASED TREATMENT OF OPIOID USE DISORDERS WITH BUPRENORPHINE Cross-Cutting Research Small Business Programs NIDA emocha Mobile Health, Inc. Seiguer, Sebastian Owings Mills, MD 2019
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.
1R61DA057629-01A1
Chicago Data-driven OUD Screening, Engagement, Treatment and Planning (C-DOSETaP) System Cross-Cutting Research Translating Data 2 Action to Prevent Overdose NIDA UNIVERSITY OF ILLINOIS AT CHICAGO KARNIK, NIRANJAN Chicago, IL 2023
NOFO Title: HEAL Initiative: HEAL Data2Action – Innovation and Acceleration Projects, Phased Awards (R61/R33, Clinical Trial Optional)
NOFO Number: RFA-DA-23-057
Summary:

Health services for the treatment of opioid use disorder (OUD) are fragmented in west Chicago, an epicenter for overdose deaths. This project will develop a data-driven opioid response plan involving key partners. These include local health departments, community organizations, health care systems, and people with lived experience. The research will develop a digital screening tool for OUD that can be used in hospitals and their emergency departments. The tool will be built from machine learning of data from electronic health records, the prescription drug monitoring program, and patient-reported measures. The research will test the value of the screening tool for connecting people to treatment and preventing fatal overdoses mortality in local neighborhoods.
1R43DA050397-01
Development of cannabinoid-opioid combination with opioid sparing and synergistic analgesic effects to prevent opioid use disorder and overdose. Cross-Cutting Research Small Business Programs NIDA BDH PHARMA, LLC BRIONES, MARISA Valley Village, CA 2019
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:

With the entwined crises of opioid use and chronic pain, there is a need for alternative, safe therapies to manage opioid use disorder, opioid withdrawal symptoms, chronic pain, and/or associated anxiety and depression. A proof-of-concept preclinical study has already been conducted of a cannabinoid-opioid combination that demonstrated opioid-sparing and synergistic analgesic effects, with the combination providing greater analgesia in a rodent model of chronic pain than a standard dose of the opioid alone. This proposal aims to develop a fixed-dose combination (FDC) of the cannabinoid-opioid that may have improved analgesia with lower opioid doses and thereby lower the risk of dependence, withdrawal, diversion, abuse, and overdose. Preclinical pharmacokinetic and ?in vivo ?safety studies will help determine if co-administration alters the pharmacokinetics and/or respiratory depression related to either compound in rodents.
1R01DA057658-01
Weighting Longitudinal Data to Access Opioid Analgesia Tapering Outcomes Among Patients with Co-Occurring Chronic Pain and Substance Use Disorder Cross-Cutting Research Leveraging Existing and Real-Time Opioid and Pain Management Data NIDA LOYOLA UNIVERSITY CHICAGO QEADAN, FARES Maywood, IL 2022
NOFO Title: HEAL Initiative: Data and Methods to Address Urgent Needs to Stem the Opioid Epidemic (R01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-22-044
Summary:

Guidelines published by the Centers for Disease Control and Prevention in 2016 recommended gradual reductions in opioid medication doses (opioid tapering) for people with chronic pain and substance use disorder and recommended that those patients with pain and opioid use disorder should be switched to opioid use disorder medications. Despite wide implementation, little is known about the consequences of opioid tapering among patients with co-occurring chronic pain and substance use disorder. This project will use various databases (Cerner Real-World DataTM, American Hospital Association data, and U.S. Census data) to create a representative electronic health records database. This database will be used to determine the relationship between opioid tapering, multidisciplinary pain treatment, and medications for opioid use disorder – as well as monitor outcomes for patients with chronic pain and co-occurring substance use disorder.
R41DA055405-01
Virtual Reality Facilitation of Recovery from Opioid Use Disorder Cross-Cutting Research Small Business Programs NIDA Relate XR LLC OBERLIN, BRANDON G (contact); NELSON, ANDREW Indianapolis, IN 2022
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-19-020
Summary:

Relapse is common in people with opioid use disorder, and recovery attempts often fail within 6 months. This research project will test a novel virtual reality intervention to improve recovery outcomes for people recovering from opioid use disorder. By increasing future orientation and delay-of-reward behavior with a precision medicine personalized experience, the intervention is designed to enhance advantageous decision-making and increase positive future outcomes. The results of this study will provide critical data for creating a commercially viable software product for facilitating relapse prevention and improving opioid use disorder recovery outcomes.
1R43DA046974-01
IMPACT-Instrument to Measure Pain and Assess Correlation to Treatment. Create a smartphone pupillometry to objectively determine the presence of acute pain, evaluate opioid as the treatment for pain. Cross-Cutting Research Small Business Programs NIDA BENTEN TECHNOLOGIES, INC MA, TONY XUYEN Manassa, VA 2019
NOFO Title: Development of a Device to Objectively Measure Pain (R43/R44)
NOFO Number: RFA-DA-18-012
Summary:

While patient self-report of pain is the gold standard of pain measurement, this may not be feasible in critically ill patients who are sedated and intubated, unconscious, or unable to verbally communicate. Pupillary dilation (PD) is a reliable indicator of acute pain, and measurement of pupil size changes may be useful in determining the intensity of pain experienced as well as the efficacy of an analgesia. Research also demonstrates that pupillary unrest under ambient light (PUAL) is an objective marker of sensitivity to opioids, and facial expression analysis can help detect pain. Benten Technologies, Inc. aims to develop and validate IMPACT, a device that uses pupillometry with a proprietary algorithm to measure both PD and PUAL and conduct facial expression analysis using computer vision. The project team will then demonstrate the feasibility of IMPACT in helping clinicians objectively determine pain and assess opioid efficacy and compare results obtained to pain scores reported by patients.