Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3AR077360-01
A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY COHEN, STEVEN P (contact); CAMPBELL, CLAUDIA MICHELLE; CASTILLO, RENAN C Baltimore, MD 2019
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

The goal of this proposal is to conduct a randomized controlled trial to evaluate the comparative effectiveness of conservative behavioral and nonopioid pharmacological treatments (Phase I) and, among nonresponders, the benefits of nonsurgical procedural interventions (Phase II). Aim 1 will evaluate the effectiveness of individual and combined online cognitive behavioral therapy (painTRAINER) and pharmacologic treatment (duloxetine) in improving pain and function for knee osteoarthritis (KOA) patients compared with standard of care. Aim 2 will determine if genicular nerve radiofrequency ablation or intra-articular injection of hyaluronic acid and steroid is more effective in improving outcomes than local anesthetic nerve block or standard of care and help establish the role of these interventional treatments in the overall management of pain in KOA patients. Aim 3 will test whether clinical and psychosocial phenotypes predict short- and long-term treatment response.
3R01MD009063-05S1
ETHNIC DIFFERENCES IN ENDOGENOUS PAIN REGULATION: PET IMAGING OF OPIOID RECEPTORS Clinical Research in Pain Management NIMHD Johns Hopkins University CAMPBELL, CLAUDIA MICHELLE Baltimore, MD 2018
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Ethnic groups show substantial variability in the experience of acute and clinical pain, with African Americans (AAs) having more clinical pain conditions and higher levels of pain severity and pain-related disability compared to non-Hispanic whites (NHW). Ethnic differences in opioid neurotransmitters suggest that these systems function less efficiently among AAs and may account for differences in pain and analgesic responses. The overwhelming majority of clinically used opioids elicit their effects through activation of the mu-opioid receptor, making it a relevant target for investigation. We propose to examine ethnic differences in the supraspinal endogenous opioid system using positron emission tomography (PET) imaging of mu-opioid receptors employing the mu-selective agonist [11C]carfentanil. Healthy AAs and sex-, age-, SES-matched NHW participants will undergo one baseline (non-pain) and one capsaicin-induced pain PET session using [11C]carfentanil. The current proposal will measure µ-opioid binding potential and examine its role in ethnic group differences in pain sensitivity.
3UH3AR077360-03S1
A sequenced-strategy for improving outcomes in patients with knee osteoarthritis pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY CAMPBELL, CLAUDIA MICHELLE (contact); CASTILLO, RENAN C; COHEN, STEVEN P Baltimore, MD 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:

Knee osteoarthritis is one of the leading causes of disability worldwide, particularly among older adults. Despite multiple guidelines for care, most patients do not receive adequate treatment, and about 30% are prescribed long-term opioids. This award will be used to recruit and support an early career faculty member from a group underrepresented in biomedicine. This research, part of the Pain Management Effectiveness Research Network will evaluate conservative and more aggressive treatments for knee osteoarthritis and determine which individual-level factors contribute to treatment outcomes.
1R61AT012279-01
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.
1U01DA055350-01
7/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA JOHNS HOPKINS UNIVERSITY VOLK, HEATHER E (contact); PEKAR, JAMES J; SATIN, ANDREW J Baltimore, MD 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 10 years of life. This study will be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.
1UG3AR083838-01
Improving Function and Reducing Opioid Use for Patients with Chronic Low Back Pain in Rural Communities Through Improved Access to Physical Therapy Using Telerehabilitation Clinical Research in Pain Management Prevention and Management of Chronic Pain in Rural Populations NIAMS JOHNS HOPKINS UNIVERSITY SKOLASKY, RICHARD L (contact); MCLAUGHLIN, KEVIN Baltimore, MD 2023
NOFO Title: HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3, Clinical Trials Required)
NOFO Number: RFA-NR-23-001
Summary:

Physical therapy is the recommended treatment for patients with low back pain and is a cost-effective method for improving pain and reducing disability. However, only 7-13% of patients receive physical therapy services. Access is particularly limited in rural communities due to lack of provider availability, transportation, and missed work time. These factors have contributed to more low back pain-related disability and opioid use among rural populations. Physical therapy delivered through telemedicine may improve access by reducing patient-reported barriers. This randomized clinical trial will compare an innovative, patient-centered telemedicine version of physical therapy to a currently used psychologically based educational approach for rural patients with chronic low back pain. The research will match individual patients to a treatment approach based on their psychosocial risk of poor outcomes.
1R01DK123138-01
Validation of peripheral CGRP signaling as a target for the treatment of pain in chronic pancreatitis Preclinical and Translational Research in Pain Management Discovery and Validation of Novel Targets for Safe and Effective Treatment of Pain NIDDK JOHNS HOPKINS UNIVERSITY PASRICHA, PANKAJ J Baltimore, MD 2019
NOFO Title: Discovery and Validation of Novel Targets for Safe and Effective Pain Treatment (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-NS-18-043
Summary:

Chronic pancreatitis (CP) and the debilitating pain associated with it remains a common and challenging clinical syndrome that is difficult to treat effectively. Using rodent models of CP, preliminary studies have found that nerve growth factor (NGF) and transforming growth factor beta (TGFb) appear to be acting by the common effector, calcitonin-gene related peptide (CGRP), to induce pain in CP. CGRP is known to mediate pain as a neurotransmitter in the central nervous system, specifically as a potent vasodilator involved in migraine. This project will test the hypothesis that peripheral CGRP is a major mediator of peripheral nociceptive sensitization in CP, and that peripherally restricted anti-CGRP treatment could provide an efficient and sufficient approach for the treatment of pain in pancreatitis
3UG1DA040314-05S5
Determining the Optimal Duration of Buprenorphine Treatment to Reduce the Risk of Relapse, Overdose, and Mortality Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
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 seeks to address the priority of the optimal duration of buprenorphine treatment to reduce the risk of relapse, overdose and mortality outcomes using observational data. Answering this question with a randomized trial raises ethical concerns. Observational studies with large datasets can address these important questions relatively quickly. At the same time, observational studies pose their own methodologic challenges related to confounding, misclassification of exposure and outcome, and informative loss to follow-up. This study will identify and quantify the potential for these sources of bias and then conduct analyses to address the questions of interest (risk of relapse, overdose and mortality).
3UG1DA040314-05S6
OUD Phenotyping Feasibility for Clinical Trials Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials.
3UG1DA040314-04S3
Developing a Prescription Opioid Registry Across Diverse Health Systems Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products.
3-UH3-AT010739-02
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J (contact); DEBAR, LYNN L Oakland, CA 2021
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-21-025
5UH3AT010739-04
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE DEBAR, LYNN L (contact); COOK, ANDREA J Oakland, CA 2023
NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005
3UG1DA040314-04S4
Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Kaiser Foundation Research Institute CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective.
3R01DA042059-04S2
THE SAFETY AND IMPACT OF EXPANDED ACCESS TO NALOXONE IN HEALTH SYSTEMS New Strategies to Prevent and Treat Opioid Addiction Preventing Opioid Use Disorder NIDA Kaiser Foundation Research Institute BINSWNGER, INGRID A Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
3U19MH121738-02S2
Buprenorphine Effect on Suicidal Behavior New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH KAISER FOUNDATION RESEARCH INSTITUTE SIMON, GREGORY E Oakland, CA 2020
NOFO Title: Notice of Special Interest: HEAL Supplements to Improve the Treatment and Management of Common Co-occurring Conditions and Suicide Risk in People Affected by the Opioid Crisis
NOFO Number: NOT-MH-20-025
Summary:

Mortality and morbidity related to suicidal behavior and opioid use disorder (OUD) have increased significantly over the past decade. These two public health crises are intertwined at multiple levels. Medications for OUD, especially buprenorphine, have been shown to decrease opioid use and reduce the multiple negative consequences of OUD, including fatal and nonfatal overdose, criminal justice involvement, infectious complications, and misuse of other substances. In addition, small randomized trials of buprenorphine treatment in treatment-resistant depression (with or without co-occurring OUD) suggest that buprenorphine reduces depressive symptoms and suicidal ideation. This large study will evaluate the effects of starting buprenorphine treatment on self-harm and suicide attempt among people with opioid use disorder, including those with and without co-occurring mental health conditions or other known risk factors for suicidal behavior. Comprehensive health records data from four large health systems serving a combined member/patient population of approximately 11 million will be examined for the overall effect of buprenorphine treatment on subsequent self-harm or suicide attempt, including differences in effects between patient subgroups and specificity of effects to buprenorphine vs other medications.
3UH3AT010739-03S1
Improving Diversity, Inclusion, and Retention in BackinAction/AcuOA Clinical Research in Pain Management NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J Oakland, CA 2021
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-21-025
Summary:

Participants in many clinical trials do not represent the U.S. population. Racial/ethnic minorities are often underrepresented, as are people with lower socioeconomic status and lower education levels, who face additional barriers, such as lack of transportation or childcare. Thus, both recruitment and retention of such populations is challenging, particularly for complementary and integrative health trials. This project proposes to enhance diversity, inclusion, and retention of participants in an ongoing study by creating a patient and caregiver Diversity, Recruitment, and Retention Advisory Board as well as adding a recruitment and retention specialist to coordinate the advisory board and implement necessary activities. The project will also provide evidence-based recruitment tools and will conduct structured interviews with patients who choose not to participate in a study as well as those who are at risk of dropping out to enhance understanding of the barriers and factors contributing to trial recruitment, loss to follow-up, and successful completion.
1UG3AG067493-01
Tailored Non-Pharmacotherapy Services for Chronic Pain: Testing Scalable and Pragmatic Approaches Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIA KAISER FOUNDATION RESEARCH INSTITUTE DEBAR, LYNN L Oakland, CA 2019
NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

To enhance availability of cognitive behavioral therapy for chronic pain (CBT-CP), this study will 1) refine strategies to identify and recruit patients, finalize intervention procedures, and ensure data infrastructure and quality; 2) determine the effectiveness of online and telephonic CBT-CP on patients and pain severity and secondary outcomes, including depression, sleep, quality of life, and pain-related health care utilization, from the electronic health record; and 3) assess the cost and incremental cost-effectiveness of online and telephonic CBT-CP compared with usual care. Eligible participants will be randomized to one of two painTRAINER interventions or usual care. Interventions will be eight weekly 45-minute sessions of the online program or telehealth-style phone coaching by trained behavioral health specialists. Self-reported pain severity and secondary outcomes will be assessed at baseline and at three, six, and 12 months.
1UF1MH121949-01
Patient-centered team-based primary care to Treat Opioid Use Disorder, Depression, and Other conditions New Strategies to Prevent and Treat Opioid Addiction Optimizing Care for People with Opioid Use Disorder and Mental Health Conditions NIMH KAISER FOUNDATION RESEARCH INSTITUTE DEBAR, LYNN L (contact); BRADLEY, KATHARINE ANTHONY Oakland, CA 2019
NOFO Title: HEAL Initiative: Effectiveness Trials to Optimize, Implement, Scale, and Sustain the Collaborative Care Model for Individuals with Opioid Use Disorders and Mental Health Conditions (U01 Clinical Trial Required)
NOFO Number: RFA-MH-19-525
Summary:

Some medications for opioid use disorder (MOUD) can be provided in primary care (PC). Systems of team-based PC show promise for improving access and retention in OUD treatment. One such model, collaborative care (CC), includes a care manager, supervised by experts, who help provide evidence-based high-quality OUD care. While CC improves outcomes of depression, other mental health and substance use (MH/SU) disorders and pain, it is unknown how to optimally integrate CC for OUD with other MH/SU disorders. This pragmatic trial tests whether our model of CC for OUD and comorbid conditions increases engagement in MOUD treatment and improves depression symptoms in PC patients with OUD and depression. Innovative pragmatic elements include inclusion of all eligible patients in participating PC clinics, random recruitment and consent, and measurement of main outcomes using only secondary data. These pragmatic elements avoid studying only motivated patients and avoid activating patients randomized to usual care.
3UG1DA040314-04S5
OUD Phenotyping Feasibility for Clinical Trials (CTN-0092) Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA Kaiser Foundation Research Institute Campbell, Cynthia Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials.
3UG1DA040314-04S5
OUD Phenotyping Feasibility for Clinical Trials Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY Oakland, CA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

Very little research has been conducted on better understanding of phenotypic characterization of individuals with OUD (beyond DSM-5 diagnoses) and how these features predict illness severity, treatment retention or outcomes. The primary objective of the deep phenotyping study is to provide a comprehensive phenotypic characterization (e.g., domains of negative affect, reward salience, cognitive control, mental health) of a heterogeneous sample of individuals (n = 1,000) who currently meet one or more DSM-5 diagnostic criteria for OUD and are in treatment for OUD. In a subset of this sample (n = 100), the investigators conduct digital phenotyping to examine the utility of ecological momentary assessment (EMA), digital sensing and social media to predict retention, medication adherence and opioid use outcomes in patients receiving buprenorphine for OUD. It is anticipated that this foundational study will inform the feasibility and utility of such assessments that can be successfully embedded into imminent and future CTN and other OUD clinical trials.
1UG3AT010739-01
Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults Clinical Research in Pain Management Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) NCCIH KAISER FOUNDATION RESEARCH INSTITUTE SHERMAN, KAREN J (contact); DEBAR, LYNN L Oakland, CA 2019
NOFO Title: HEAL Initiative: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-AT-19-005
Summary:

Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.
3UG1DA040314-04S7
Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY Oakland, CA 2019
NOFO Title: The National Drug Abuse Treatment Clinical Trials Network (UG1)
NOFO Number: RFA-DA-15-008
Summary:

Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective.
3UG1DA040314-05S3
Primary Care Opioid Use Disorders Treatment Trial (PROUD) Economic Analysis Study Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

Effective treatment for OUD has been shown to improve patient outcomes and reduce health care costs; however, evidence of this effect in primary care settings is severely limited. The health economic findings from this study will supplement the parent PROUD trial’s results regarding clinical effectiveness and implementation outcomes and provide critical contextual information for health systems and other health care stakeholders. The study will evaluate the economic viability of the PROUD collaborative care model for OUD—that is, from the perspective of the health care sector, to what extent do the downstream cost savings associated with improved patient outcomes offset the additional costs of the PROUD intervention? The specific aims are to (1) estimate the start-up and ongoing management costs of the PROUD intervention, (2) assess costs associated with health care utilization for patients who receive primary care treatment in PROUD and usual care clinics and have been identified with recognized OUDs before clinic randomization, and (3) estimate the economic value of the PROUD intervention, measured as net monetary benefit (NMB, incremental benefit minus incremental cost), from the health care sector perspective.
3UG1DA040314-05S4
Developing a Prescription Opioid Registry Across Diverse Health Systems Translation of Research to Practice for the Treatment of Opioid Addiction Enhancing the National Drug Abuse Treatment Clinical Trials Network to Address Opioids NIDA KAISER FOUNDATION RESEARCH INSTITUTE CAMPBELL, CYNTHIA I; BRADLEY, KATHARINE ANTHONY; WEISNER, CONSTANCE M. Oakland, CA 2019
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

The opioid crisis continues its highly negative impact, with more than 49,000 opioid-related overdose deaths in 2017. In 2016, the Centers for Disease Control and Prevention (CDC) issued guidelines for opioid prescribing that included opioid dosing and risk mitigation strategies, and health systems implemented similar initiatives even earlier. This has resulted in a quickly changing and more conservative prescribing environment. National data indicate the number of prescriptions has fallen between 2013 and 2016. Registries and electronic health record (EHR) data are increasingly cited as valuable resources to address critical research questions on opioid use with high efficiency. To our knowledge, no investigators have established an EHR-based prescription opioid registry across several diverse health systems with common data algorithms with the flexibility to address multiple questions. The goal of the proposed research is to develop a prescription opioid registry across 10 diverse health systems with harmonized EHR data from years 2012-2018 and leverage it to answer several key “next-step” research questions in response to the opioid crisis. The registry will include medications prescribed for treatment of OUD, including buprenorphine products.
9R42NS120548-02A1
Development of KLS-13019 for Neuropathic Pain Cross-Cutting Research Small Business Programs NINDS KANNALIFE SCIENCES, INC. BRENNEMAN, DOUGLAS ERIC (contact); WARD, SARA J Lloyd Harbor, NY 2021
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:

Neuropathic pain adversely affects quality of life and remains challenging to treat, presenting high unmet medical need. One example of this type of pain, chemotherapy-induced peripheral neuropathy, is a chronic, severely debilitating consequence of cancer therapy for which there are no effective treatment strategies. This research is testing a new cannabidiol (CBD) analogue (KLS-13019) with neuroprotective properties and which has improved drug-like properties compared to CBD. This project will optimize the process to manufacture KLS-13019, develop analytical methods, optimize its formulation, evaluate its safety and toxicity, and test KLS-13019’s efficacy of in a rat model of chemotherapy-induced peripheral neuropathy.