Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title Sort ascending | Research Focus Area | Research Program | Administering IC | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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1UG3AR076573-01
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Randomized-controlled trial of virtual reality for chronic low back pain to improve patient-reported outcomes and physical activity | Clinical Research in Pain Management | Back Pain Consortium Research Program | NIAMS | CEDARS-SINAI MEDICAL CENTER | SPIEGEL, BRENNAN | Los Angeles, CA | 2019 |
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AR-19-029 Summary: Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for musculoskeletal pain, including chronic low back pain (cLBP). Users of VR wear a pair of goggles with a close-proximity stereoscopic screen that creates a sensation of being transported into lifelike, three-dimensional worlds. By stimulating the visual cortex while engaging other senses, VR modulates the user’s processing of nociceptive stimuli. Functional magnetic resonance imaging (fMRI) of the brain reveals that VR has similar effects on the sensory and insular cortex as opioids, and head-to-head trials show that VR achieves similar or greater analgesia as hydromorphone. Since there are few data regarding long-term efficacy and safety of VR in cLBP, this study will measure patient-reported outcomes, biometric outcomes, and opioid use in nonspecific cLBP patients under various experimental conditions using VR therapy. |
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3U01DK123786-01S1
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Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER) | Cross-Cutting Research | Increasing Participant Diversity, Inclusion, and Engagement in HEAL Research | NIDDK | UNIVERSITY OF WASHINGTON | MEHROTRA, RAJNISH | Seattle, WA | 2022 |
NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-22-066 Summary: Pain is a common problem for people with end-stage renal disease that receive hemodialysis. Opioid use rates in this population are almost three times that of the general U.S. population over 65, putting them at significant risk for addiction. This research is testing treatments to manage chronic pain in this patient population. This project will develop educational materials to overcome barriers to telehealth toward enhancing research participation by American Indian/Alaska Native communities. |
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1U01DK123786-01
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Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER) | Clinical Research in Pain Management | Integrated Approach to Pain and Opioid Use in Hemodialysis Patients | NIDDK | UNIVERSITY OF WASHINGTON | MEHROTRA, RAJNISH (contact); CUKOR, DANIEL ; UNRUH, MARK LYNN | Seattle, WA | 2019 |
NOFO Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Clinical Centers (U01 Clinical Trial Required)
NOFO Number: RFA-DK-18-030 Summary: For patients with end-stage renal disease treated with long-term hemodialysis (HD), the safety and efficacy of behavioral interventions alone or augmented by safer drugs remain untested. This study will perform a multicenter parallel group randomized controlled trial to test the efficacy of two interventions to reduce opioid use in HD patients. Seven hundred and twenty HD patients with significant and ongoing opioid use will be randomly assigned to (1) telehealth cognitive behavioral therapy (CBT) alone, (2) telehealth CBT augmented by transdermal buprenorphine, and (3) usual care, with follow-up for up to one year. The primary outcome will be prescribed morphine milligram equivalent (MME) over the preceding four weeks. Three patient-reported outcomes (interference by pain, functional status, and quality of life) will comprise the secondary outcomes. |
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1R44DA046151-01
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RAE (REALIZE, ANALYZE, ENGAGE)- A DIGITAL BIOMARKER BASED DETECTION AND INTERVENTION SYSTEM FOR STRESS AND CRAVING DURING RECOVERY FROM SUBSTANCE ABUSE DISORDERS | Cross-Cutting Research | Small Business Programs | NIDA | ContinueYou, LLC | Reinhardt, Megan Rois | Bristol, ME | 2019 |
NOFO Title: Wearable to Track Recovery and Relapse Factors for People w/ Addiction (R43/R44)
NOFO Number: RFA-DA-18-010 Summary: For many individuals in recovery from a substance use disorder, certain cues—including stress and drug-related cues—can trigger a physiological state in which they are more likely to relapse. In this SBIR project, the investigators intend to deploy a system—consisting of a wearable sensor, a smartphone app, and a clinical portal—to provide individuals in recovery and their treatment providers with an opportunity to identify moments of high risk for relapse and to access real-time intervention opportunities. The sensors will identify signals of stress or drug use, interface with a smartphone app, and provide options for annotations, stress-reduction techniques, or contact with an individual’s support system and treatment providers, as well as log and encourage healthy behaviors. This study will deploy and optimize the system, as well as test its effects on addiction-related outcomes, such as rate of relapse. |
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1UG3DA050271-01
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R-methadone-TAAP/MPAR: an abuse deterrent methadone prodrug with overdose protection: Pre-Clinical Development and Phase 1 Clinical Trial | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | Ensysce Biosciences, Inc. | Kirkpatrick, Lynn | San Diego, CA | 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: Methadone is useful in the treatment of opioid dependence; however, methadone misuse and methadone-related fatalities have increased. Ensysce has created two complementary, novel technologies that can be applied to methadone. Their Trypsin Activated Abuse Protection (TAAP™) prodrugs are “enzyme-activated” to release clinically effective opioid drugs only when taken orally and exposed to the correct physiologic conditions, such as exposure to trypsin in the small bowel. Their multi-pill abuse resistance (MPAR™) feature involves in situ bioregulation of opioid delivery from the TAAP™ systems, enabling control over oral multi-dose pharmacokinetic profiles. It is envisaged that an R-methadone-TAAP™ prodrug would demonstrate similar reduced addiction liability as with other opioid-TAAP products. The objective of this proposal is to develop an R-methadone-TAAP™/MPAR™ drug through Phase 1 clinical studies and to translate R-methadone-TAAP™/MPAR™ results into humans, to ultimately reduce the misuse and oral overdose potential of methadone. |
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3UG1DA049467-03S3
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Quantifying How Cocaine Users Respond to Fentanyl Contamination in Cocaine | Translation of Research to Practice for the Treatment of Opioid Addiction | Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids | NIDA | RUSH UNIVERSITY MEDICAL CENTER | KARNIK, NIRANJAN | Chicago, IL | 2021 |
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 increased presence of fentanyl in cocaine has drastically increased cocaine-related overdoses, yet there is no research quantifying how cocaine users respond to fentanyl adulteration. In this online study, a modification of a behavioral economics measure, the Cocaine Purchase Task, will quantify for the first time how cocaine users respond to fentanyl contamination in cocaine. This study aims to 1) Determine how possible fentanyl adulteration affects cocaine demand, and 2) Determine which individual characteristics moderate the relationship between fentanyl adulteration and cocaine demand. Determining how possible fentanyl adulteration affects cocaine demand can help inform the development of effective harm reduction interventions for people who use cocaine to address the worsening crisis of opioid related deaths. |
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1R61AT012279-01
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Quantifying and Treating Myofascial Dysfunction in Post Stroke Shoulder Pain | Clinical Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NCCIH | JOHNS HOPKINS UNIVERSITY | RAGHAVAN, PREETI | Baltimore, MD | 2022 |
NOFO Title: HEAL Initiative: Developing Quantitative Imaging and Other Relevant Biomarkers of Myofascial Tissues for Clinical Pain Management
NOFO Number: RFA-AT-22-003 Summary: Shoulder pain occurs in many patients who are recovering from a stroke. In addition to impairments in the ability to move, persistent shoulder pain contributes to depression, and often reduces quality of life. Although the cause of post-stroke shoulder pain is complex and not completely understood, it is thought to arise in part to damage of muscles and surrounding connective tissues (myofascial tissues) in the shoulder. This project will use advanced medical imaging techniques to create biomarkers of that can reliably identify myofascial tissues. The research will then test the ability of these biomarkers to monitor, and ultimately predict treatment responses in patients with post-stroke shoulder pain in the context of a randomized controlled clinical trial. |
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1R24NS132283-01
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PURPOSE: Positively Uniting Researchers of Pain to Opine, Synthesize, and Engage | Cross-Cutting Research | Training the Next Generation of Researchers in HEAL | NINDS | NEUROVATIONS | COVERSTONE, JACOB SUTTON | Napa, CA | 2022 |
NOFO Title: Emergency Awards: HEAL Initiative: Coordinating Center for National Pain Scientists Career Development (R24 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-22-060 Summary: The Interagency Pain Research Coordinating Committee has identified a need for organized opportunities for early-stage pain researchers to meet and learn from more experienced pain researchers and mentors – who are exiting the field at a faster rate than they are being replaced. This project will create a coordinating center for early-stage pain researchers, with an online networking platform to encourage interactions and collaboration among these scientists. The research will also develop a training curriculum and make it accessible to NIH funded, early-stage pain scientists. |
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1U01DA047713-01
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PTPRD ligands for stimulant and opiate use disorders | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | BIOMEDICAL RESEARCH INSTITUTE OF NEW MEX | Uhl, George Richard | Albuquerque, NM | 2019 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-18-219 Summary: There are no FDA-approved medications for stimulant use disorders, and therapies for opioid use disorders remain suboptimal in ways that are now a focus of national attention. Thus, there is a clear need to identify new targets and explore new approaches for addiction medication development. Several lines of evidence suggest that PTPRD (receptor type protein tyrosine phosphatase D) may be a promising target for development of pharmacotherapeutics to treat not only stimulant use disorders but opioid use disorders as well. This research will focus on improving existing PTPRD ligands, identifying their effects on the dopamine and opioid systems, and moving the best novel, patentable PTPRD ligands toward human studies. If successful, this project will generate novel, well-tolerated, and bioavailable PTPRD ligands that display in vitro potency, selectivity and stability, and in vivo modulation of both cocaine and opioid-mediated reward at doses that present no significant toxicity. |
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1R21AT012431-01
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Psychosocial Risk Factors for Chronic Pain: Characterizing Brain and Genetic Pathways and Variation Across Understudied Populations | Cross-Cutting Research | Leveraging Existing and Real-Time Opioid and Pain Management Data | NCCIH | DARTMOUTH COLLEGE | WAGER, TOR D | Hanover, NH | 2022 |
NOFO Title: HEAL Initiative: Secondary Analysis and Integration of Existing Data Related to Acute and Chronic Pain Development or Management in Humans (R21 Clinical Trials Not Allowed)
NOFO Number: RFA-DE-22-011 Summary: Fifty million Americans experience chronic pain, including about 25 million who report pain that substantially interferes with daily activities and reduces quality of life. Mental health problems, including depression, anxiety, and post-traumatic stress disorder, increase risk for severe chronic pain. This project will use genetic data, information about observable characteristics (phenotypic data), and neuroimaging data from three large databases to identify psychosocial factors that predict chronic pain, assess differences across diverse U.S. populations, and determine whether risk profiles predict post-surgical chronic pain. |
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1R21AT010106-01
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PSYCHOSOCIAL PAIN MANAGEMENT TO IMPROVE OPIOID USE DISORDER TREATMENT OUTCOMES | New Strategies to Prevent and Treat Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | University of Michigan, Ann Arbor | ILGEN, MARK A. | ANN ARBOR, MI | 2018 |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 Summary: Many individuals who receive medication-assisted therapy (MAT) leave treatment early and continue to struggle with opioid use disorder (OUD), often within the context of poorly managed comorbid chronic pain. Psychosocial interventions for pain have been effective in patients with chronic pain and substance use disorders, but these interventions have not been examined in the OUD population receiving MAT. This study proposes to refine and adapt a psychosocial pain management intervention (PPMI) delivered by telephone for patients with OUD receiving MAT and then to conduct a randomized controlled trial of the intervention in patients receiving MAT to improve adherence and pain- and substance-related outcomes. The intervention uses elements of cognitive behavioral pain management interventions adapted specifically for patients with OUD receiving MAT. The new intervention will be compared to an enhanced usual care condition (EUC) in 100 patients. |
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4R33AT010106-02
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Psychosocial pain management to improve opioid use disorder treatment outcomes | Translation of Research to Practice for the Treatment of Opioid Addiction | Behavioral Research to Improve Medication-Based Treatment | NCCIH | University of Michigan at Ann Arbor | ILGEN, MARK | Ann Arbor, MI | 2019 |
NOFO Title: Clinical Trials or Observational Studies of Behavioral Interventions for Prevention of Opioid Use Disorder or Adjunct to Medication Assisted Treatment-SAMHSA Opioid STR Grants (R21/R33)
NOFO Number: RFA-AT-18-002 |
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3R01DA044522-16S1
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PROXIMAL AND DISTAL PATHWAYS TO YOUNG ADULT OPIOID MISUSE | New Strategies to Prevent and Treat Opioid Addiction | Preventing Opioid Use Disorder | NIDA | University of Washington | OESTERLE, SABRINA | Seattle, WA | 2019 |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 |
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1K24AT011995-01
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Providing training in effective non-opioid options for the treatment of pain conditions | Clinical Research in Pain Management | NCCIH | UNIVERSITY OF ILLINOIS AT CHICAGO | Doorenbos, Ardith Z | Chicago, IL | 2021 | |
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193 Summary: Over-the-counter medicines such as non-steroidal anti-inflammatory drugs are ineffective for treating severe chronic pain and may have serious side effects from continued use, which limits treatment options. A kinase (an enzyme whose activity targets a specific molecule) called TAK1 is involved in the chronic pain process. This research will develop a molecule previously shown to be effective in a model of inflammatory pain that also inhibits TAK1. A main goal will be to determine if this inhibitor (takinib analog HS-276) can cross the blood-brain barrier and, if successful, pursue FDA Investigative New Drug-enabling safety studies leading to a Phase I clinical trial and a potential new chronic pain treatment. |
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1R41NS127637-01A1
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Protease-Activated-Receptor-2 Antagonists for Treatment of Migraine Pain | Cross-Cutting Research | Small Business Programs | NINDS | PARMEDICS, INC. | DEFEA, KATHRYN (contact); DUSSOR, GREGORY O | Temecula, CA | 2023 |
NOFO Title: HEAL Initiative: Development of Therapies and Technologies Directed at Enhanced Pain Management (R41/R42 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-20-009 Summary: There is a need for additional effective treatments for migraine, which affects more than 36 million people in the United States. This project will develop an oral medication to disrupt the biological processes that drive migraine pain, which include nerve inflammation in response to pain signals. |
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3R01NS098826-02S1
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PROTEASE ACTIVATED RECEPTOR TYPE 2 TARGETING FOR MIGRAINE PAIN | Preclinical and Translational Research in Pain Management | NINDS | UNIVERSITY OF TEXAS DALLAS | PRICE, THEODORE J; BOITANO, SCOTT; DUSSOR, GREGORY O; VAGNER, JOSEF | RICHARDSON, TX | 2018 | |
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591 Summary: Migraine is the most common neurological disorder. Currently available treatments fail to effectively manage migraine in most patients. Development of new therapeutics has been slow due in large part to a poor understanding of the underlying pathology of migraine. Endogenous proteases, released in the meninges by resident mast cells, have been proposed as a potential driver of migraine pain via an action on protease activated receptor type 2 (PAR2). The central hypothesis is that PAR2 expression in nociceptors that project to the meninges plays a key role in the pathogenesis of migraine pain. The aims are to: 1) use the established PAR2 development pipeline to design new PAR2 antagonists with improved drug-like properties; 2) use pharmacological tools in a novel mouse migraine model to further understand the potential role of PAR2 in migraine; and 3) use mouse genetics to study the cell type–specific role of PAR2 in migraine pain. |
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3R01MD010372-03S1
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PROSPECTIVE STUDY OF RACIAL AND ETHNIC DISPARITIES IN CHRONIC PAIN AND PAIN BURDEN | Clinical Research in Pain Management | NIMHD | Rand Corporation | MARSHALL, GRANT | Santa Monica, CA | 2018 | |
NOFO Title: Mechanisms, Models, Measurement, & Management in Pain Research (R01)
NOFO Number: PA-13-118 Summary: Data suggest that members of minority groups are more likely to develop chronic pain and to have greater pain burden. We will identify a set of promising intervention targets for reducing or eliminating racial/ethnic pain disparities. We will interview adult survivors of serious physical injury, comprised of roughly equal proportions of African-Americans (AA), Latinos, and non-Latino Whites (NLW), and examine their medical records for information on injury severity and medication use in-hospital. Our aims are to determine whether: 1) AA and Latino physical injury survivors experience more severe pain relative to NLW; 2) AA and Latino injury survivors experience greater pain burden relative to NLW counterparts; 3) differences in pain severity burden are linked to a set of target candidates for interventions; and (4) pain outcomes in at-risk minority groups can be linked to a set of target candidates for group-tailored interventions to reduce pain severity and pain burden. |
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1UG3AR076568-01
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Proof of concept study to treat negative affect in chronic low back pain | Clinical Research in Pain Management | Back Pain Consortium Research Program | NIAMS | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | WASAN, AJAY D | Pittsburgh, PA | 2019 |
NOFO Title: HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AR-19-029 Summary: The chronic low back pain (cLBP) subgroup with comorbid depression or anxiety disorders, known as high negative affect (NA), needs better non-opioid, comprehensive pain treatment options. Data shows that the combination of antidepressants (AD) and fear avoidance physical therapy is more efficacious at improving pain, function, depression, and anxiety in cLBP patients with high NA than each treatment alone or a control condition. Research also finds that an enhanced fear avoidance rehabilitation protocol (EFAR; fear avoidance-based physical therapy, pain education, and motivational messaging) further improves outcomes. To address the unmet needs of cLBP patients with high NA, this study will test in a randomized trial whether the combination of AD and EFAR is more effective than each treatment alone at relieving pain, improving function, combating depression, and preventing opioid misuse. This multimodal combination approach of pharmacotherapy and behavioral therapy is novel to the field and has the potential to shift current treatment paradigms. |
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1R61DA059895-01
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Promoting Retention in Opioid Treatment among Women Experiencing Intimate Partner Violence: A Novel Stepped Care Model Targeting PTSD | Translation of Research to Practice for the Treatment of Opioid Addiction | Optimizing the Quality, Reach, and Impact of Addiction Services | NIDA | YALE UNIVERSITY | SULLIVAN, TAMI P (contact); EDELMAN, E JENNIFER; JOHNSON, DAWN M | New Haven, CT | 2023 |
NOFO Title: HEAL Initiative: Translating Research to Practice to End the Overdose Crisis (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-DA-23-053 Summary: Women with opioid use disorder (OUD) are disproportionately impacted by physical, sexual, and psychological intimate partner violence and posttraumatic stress disorder (PTSD). Yet, treatment approaches that address all these conditions together in OUD treatment settings are lacking. To address this gap, this project will evaluate delivery of two evidence-based interventions to address PTSD (Present-Centered Therapy+ and Helping to Overcome PTSD through Empowerment) for women seeking OUD treatment who have experienced intimate partner violence. It will also determine if integrated treatment can help retain the women in medication treatment for OUD. |
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1R01DA057665-01
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Promoting Remote Harm Reduction and Secondary Services in Rural Settings (PROMOTE) Study | Translation of Research to Practice for the Treatment of Opioid Addiction | Harm Reduction Approaches to Reduce Overdose Deaths | NIDA | UNIVERSITY OF CHICAGO | PHO, MAI TUYET (contact); MACKESY-AMITI, MARY ELLEN | Chicago, IL | 2022 |
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: Access to harm reduction services are often limited in rural areas. Secondary distribution is a potentially promising strategy for rural areas that involves people sharing harm reduction supplies such as naloxone or fentanyl test strips with other people who use drugs that do not come into contact with harm reduction service providers. This project aims to examine drug use and use of harm reduction services among people in rural communities, as well as highlight factors that make people more or less likely to use secondary distribution approaches. |
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1K24NS126861-01
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Promoting high-quality chronic pain treatment trials through mentorship of junior investigators: A focus on study conduct and method development | Clinical Research in Pain Management | NINDS | UNIVERSITY OF ROCHESTER | Gewandter, Jennifer | Rochester, NY | 2021 | |
NOFO Title: Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required)
NOFO Number: PA-20-193 Summary: Enhancing the workforce of pain investigators and practitioners is a key goal of the NIH HEAL Initiative. This mentoring award leverages the resources at one of EPPIC-Net’s Specialized Clinical Centers to encourage interest in clinical pain management, in particular through multidisciplinary pain research projects. A selected investigator will train early career clinical researchers on how to develop and validate relevant pain measures and outcomes in chronic pain conditions, including chemotherapy-induced peripheral neuropathy and neuropathic chronic low back pain. Mentoring activities will include formal research and analysis, active inclusion in EPPIC-Net working groups, and collaborative writing experiences. |
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1R43DA051279-01
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Project Motivate: A digital motivation and prediction platform to improve treatment retention and reduce relapse in opioid use disorder | New Strategies to Prevent and Treat Opioid Addiction | NIDA | BIOMOTIVATE, LLC | GUTTMAN, JEREMY | Pittsburgh, PA | 2020 | |
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: One novel approach to address the opioid crisis is predicting the likelihood of retention in treatment for opioid use disorder (OUD) by assessing someone?s risk of early departure from treatment. Current methods rely on providers intuition to identify when an individual is at risk of leaving treatment early in order to intervene. This intervention, when it happens, often comes too late. Mobile health (mHealth) and Machine Learning (ML) predictive analytics offer a new opportunity to personalize OUD treatment, improve retention in OUD care, and mitigate the risk of relapse and overdose episodes. Project Motivate will combine physiological and behavioral data from disparate sources in order to predict when an individual is at risk of early departure from OUD treatment. If successful, results of the study will save lives, and lower medical costs, municipal emergency response costs, recidivism, workplace accidents, lost workplace productivity and costs to families. |
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1R61NS118651-01A1
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Prognostic Biomarkers for High-Impact Chronic Pain: Development and Validation | Preclinical and Translational Research in Pain Management | Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions | NINDS | STANFORD UNIVERSITY | MACKEY, SEAN C | Redwood City, CA | 2020 |
NOFO Title: Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain (R61/R33 Clinical Trial Optional)
NOFO Number: RFA-NS-18-041 Summary: Multidisciplinary chronic pain treatments show incomplete recovery at the population level because of significant heterogeneity on the individual level in the high impact chronic pain population. Subgroups of individuals either completely respond, do not change, or even worsen following pain management. Therefore, diagnostic biomarker signatures are needed to differentiate high impact chronic pain from low impact chronic pain. This study aims to develop prognostic biomarkers to predict the disease trajectory for individuals with musculoskeletal high-impact chronic pain. These biomarker signatures will integrate central nervous system (CNS), multi-?omic?, sensory, functional, psychosocial, and demographic domains into detection algorithms. Biomarker signatures from the proposed research are intended to facilitate risk and treatment stratification for clinical trial design and to facilitate treatment decisions in clinical practice for patients with musculoskeletal chronic pain. |
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1R34NS126030-01
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Profiling the human gut microbiome for potential analgesic bacterial therapies | Preclinical and Translational Research in Pain Management | Development and Optimization of Non-Addictive Therapies to Treat Pain | NINDS | HOLOBIOME, INC. | STRANDWITZ, PHILIP PETER (contact); GILBERT, JACK ANTHONY | Cambridge, MA | 2021 |
NOFO Title: HEAL Initiative: Planning Studies for Initial Analgesic Development Initial Translational Efforts [Small Molecules and Biologics] (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-21-016 Summary: Disruptions in make-up of the microbiome are associated with disorders characterized by chronic pain and inflammation, such as rheumatoid arthritis and fibromyalgia. The gut microbiome has immune and metabolic effects, and human gut-derived bacteria may be a source of novel, safe, and non-addictive pain treatments. However, connections between gut and pain signals, known as the “gut–pain axis,” are still poorly understood. This study aims to identify human-gut-native bacteria that i) interact with known pain targets in lab studies, ii) test their activity and analgesic/anti-inflammatory potential in an animal model, and iii) develop a computational approach to predict microbial-genetic effects on pain signals. |
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1U01DA051071-01A1
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Process Development, Manufacturing, and Preclinical Evaluation of a Monoclonal Antibody for Fentanyl Overdose | Novel Therapeutic Options for Opioid Use Disorder and Overdose | Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose | NIDA | CESSATION THERAPEUTICS, LLC | Bremer, Paul T. | San Jose, CA | 2020 |
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327 Summary: Opioid use disorder (OUD) is a significant public health problem in the United States. Particularly troubling is the rapid evolution of an opioid epidemic within the past decade, characterized by a surge in unintentional overdose deaths involving synthetic opioids, such as fentanyl. The current standard of care for opioid overdose is reversal with opioid antagonist naloxone. Naloxone is effective at reversing overdose from prescription opioids and heroin, but less effective when combating fentanyl, due to fentanyl?s high potency. Therapeutic monoclonal antibodies (mAbs) against fentanyl could overcome this problem by specifically preventing the drug from entering the central nervous system, averting overdose and attenuating opioid-induced respiratory depression. This study will develop and design of laboratory protocols needed to establish a Good Manufacturing Practice (GMP) process, quality assurance protocol, and stability profile for a new human mAb against fentanyl. Subsequent production of current GMP material will enable Good Laboratory Practice (GLP) toxicology studies in rats and dogs and eventually a Phase I/IIa clinical trial. This material will also be used in final opioid-induced respiratory depression studies in mice and non-human primates to confirm therapeutic efficacy of final drug product. If successful, these activities will enable filing for an investigational new drug application for this mAb candidate with the FDA. |