Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1UG3HL165839-01A1
Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy  (PRESENCE) Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NHLBI UNIVERSITY OF PITTSBURGH AT PITTSBURGH JONASSAINT, CHARLES RICHARD (contact); MURRAY-KREZAN, CRISTIN Pittsburgh, PA 2023
NOFO Title: HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)
NOFO Number: RFA-AT-23-002
Summary:

Pain is the most common symptom of sickle cell disease (SCD), contributing to poor physical and emotional health outcomes and exacerbating socially determined health disparities at significant societal cost. PRESENCE will be the first study to compare the effectiveness of a cognitive behavioral therapy (CBT) program with and without peer support to usual care as a non-pharmaceutical option for pain management in adolescents and young adults living with SCD. CBT is delivered through an innovative digital app that is accessed on a mobile device with one group receiving self-guided CBT, a second group receiving CBT plus peer support, and a third group receiving usual SCD care. The PRESENCE program is comprised of strong community partnerships that provide the peer support component of the intervention. Measured outcomes will include pain and emotional health.
3UG1CA189824-08S1
Wake Forest NCORP Research Base Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 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:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.
3UH3CA261067-02S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 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:

Social determinants of heath may affect breast cancer diagnosis and disease staging at time of mastectomy. It is unclear if socioeconomic factors such as annual income, marital status/single parent household, number of children, distance from the hospital, and other life stressors facing individuals from under-resourced populations affect development of postmastectomy pain syndrome or response to the drug ketamine. This research will analyze these factors toward mitigating post-mastectomy pain. This analysis will also serve as the basis for further research to define pathways that minimize health disparities plays in the development of chronic, post-surgical pain. The ultimate goal of this research is to normalize risk for chronic pain after breast surgery.

 
3UG1CA189824-08S2
Developing and Implementing a Culturally Appropriate Non-Opioid Pain Coping Skills Training Intervention for Spanish-Speaking Hispanic/Latinx Patients with Cancer Pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 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:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.
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.
3UH3AR077360-03S2
Increasing Participant Diversity in a 'Sequenced-Strategy to Improve Outcomes in People with Knee Osteoarthritis Pain (SKOAP) Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIAMS JOHNS HOPKINS UNIVERSITY COHEN, STEVEN P Baltimore, MD 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:

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.
1UG3NR019196-01
Pain Response Evaluation of a Combined Intervention to Cope Effectively (PRECICE) Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NINR WAKE FOREST UNIVERSITY HEALTH SCIENCES ANG, DENNIS CHUA Winston-Salem, NC 2020
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:

Chronic musculoskeletal pain is common and often severe enough to be disabling. Some treatments such as cognitive behavioral therapies or analgesics may relieve pain for some, but not all patients. Combining effective therapies and providing support to ensure that patients are motivated to adhere to their treatment may prove to be more beneficial to patients than prescribing a drug or recommending a single non-pharmacological treatment. This study aims to evaluate a combination of complementary treatments and Registered Nurse (RN) support to motivate patients to use and maintain combined therapies. Some patients will receive phone-based motivational interviews with an RN to enhance their adherence to pain coping skills learned through web-based cognitive behavioral therapy in combination with duloxetine, a pain-relieving drug. Others will receive both treatments but will not receive support from an RN. The study aims to determine whether motivational nursing support enhances adherence to newly learned pain coping skills, and results in improved pain relief and physical function.
3UG1CA189824-07S2
Wake Forest NCORP Research Base Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS WAKE FOREST UNIVERSITY HEALTH SCIENCES LESSER, GLENN J Winston-Salem, NC 2020
NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-044
Summary:

Pain is one of the most common symptoms in cancer patients and one least likely to be adequately treated. It is particularly common in advanced cancer, affecting an estimated 64% of patients with advanced disease. Pain treatment guidelines state patients should have access to behavioral pain interventions that educate them about pain and teach them skills for managing it. The parent grant will evaluate the effectiveness of an evidence based pain management intervention called ?Pain Coping Skills Training? in a web based format for patients with advanced cancer. This supplement will provide support for a training opportunity that aligns with the goals of the parent grant and includes community outreach and engaging underserved populations in clinical research.
1UG3CA261067-01
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NINDS NEW YORK UNIVERSITY SCHOOL OF MEDICINE WANG, JING (contact); DOAN, LISA New York, NY 2020
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-20-028
Summary:

Approximately 20% of patients who undergo surgery develop chronic pain, or Chronic Postsurgical Pain (CPSP). CPSP is highly associated with impaired functional recovery and persistent opioid use and dependence, and current standard postoperative multimodal analgesia is only moderately effective for its prevention. This study aims to determine whether the use of ketamine during and/or after surgery prevents Post-Mastectomy Pain Syndrome (PMPS), one of the most common CPSP conditions. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings. If successful, this treatment could improve postoperative pain management in individuals undergoing mastectomy and help combat the opioid epidemic.
3U24TR001609-04S1
TIN Supplement Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS Johns Hopkins University Hanley, Daniel Baltimore, MD 2019
NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002
3U24TR001608-04S1
TIN Supplement Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS Duke University Benjamin, Daniel K. Durham, NC 2019
NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002
1UG3HD102038-01
Effectiveness of an mHealth psychosocial intervention to prevent transition from acute to chronic postsurgical pain in adolescents Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NICHD SEATTLE CHILDREN'S HOSPITAL RABBITTS, JENNIFER (contact); PALERMO, TONYA M Seattle, WA 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 study team developed an mHealth pain self-management intervention for the perioperative period (SurgeryPal) to target psychosocial risk factors and teach pain self-management skills. The goal of this proposal is to establish the effectiveness of the SurgeryPal psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. The study team will plan for the efficient implementation of a multisite randomized clinical trial at 25 centers in 500 youth ages 12–18 years undergoing spinal fusion surgery and their parents. Participants will be randomized to receive SurgeryPal or attention control condition during the preoperative and postoperative phases. Self-reported pain severity and interference and secondary outcomes will be assessed at baseline, 3-, and 6-months. If effective, this scalable, low cost intervention will allow broad implementation to prevent chronic postsurgical pain in youth.
3U24TR001597-04S1
TIN Supplement Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS University of Utah Dean, Jonathan Michael Salt Lake City, UT 2019
NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002
3U24TR001579-04S1
TIN Supplement Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS Vanderbilt University Harris, Paul A Nashville, TN 2019
NOFO Title: Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)
NOFO Number: RFA-TR-15-004
3U10HD036801-21S1
MFMU HEAL Initiative Opportunity: Opioid Prescription Protocols at Discharge after cesarean delivery Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NICHD George Washington University Clifton, Rebecca Washington, DC 2019
NOFO Title: Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10)
NOFO Number: RFA-HD-13-014
Summary:

Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost universally used for post-cesarean analgesia management. Studies suggest that most women are prescribed more tablets at discharge than needed. These often go unused, providing an important reservoir contributing to the opioid crisis. Physicians struggle to prescribe and dose postoperative opioids appropriately while tackling the real needs of acute pain from surgery. Without literature to guide obstetric providers on appropriate amounts of opioids to prescribe upon discharge, actual prescription amounts nationally vary widely by up to 65 tablets. To improve post-cesarean opioid prescribing practices without compromising pain management, the study will test an individualized, patient-empowered approach for pain management and opioid prescription quantity. This is a noninferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge.
1UG3DA051241-01
Integrated Treatment for Veterans with Co-Occurring Chronic Pain and Opioid Use Disorder Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NIDA University of New Mexico WITKIEWITZ, KATIE A (contact); VOWLES, KEVIN E Albuquerque, NM 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:

Chronic pain is common, costly, and debilitating. Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for opioid dependence. Despite the alarming increases in prescription opiate misuse and opioid use disorder (OUD) nationally in the United States, there are few treatment options available that target both pain-related interference and OUD among patients with chronic pain. In military veterans, this issue is of particular importance as numerous reports indicate frequent use of opioids in the treatment of chronic pain, as well as increasing opioid-related problems. To date, there are no evidence-based treatment options that aim to both reduce pain interference while simultaneously addressing problematic opioid use. The overall aim of this study will be to determine the efficacy of an integrated psychosocial treatment in veterans with chronic pain who are taking buprenorphine for the treatment of OUD. To achieve this aim, they will utilize a randomized design to assess the efficacy of two empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness-Based Relapse Prevention for substance use and misuse.
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.
3UG1CA189824-06S1
Implementing and Evaluating mHealth Pain Coping Skills Training Interventions to Improve Self-Management of Chronic Pain in Cancer Survivors in “Real World” Clinical Practice Setting Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI Wake Forest NCORP Research Base Lesser, Glenn Winston-Salem, NC 2019
NOFO Title: NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)
NOFO Number: RFA-CA-18-015
Summary:

Pain Coping Skills Training (PCST) uses a cognitive behavioral therapy (CBT) approach to teach patients cognitive and behavioral coping skills shown to reduce pain and pain interference (e.g., relaxation, distraction, cognitive restructuring, activity pacing). Randomized controlled trials show that PCST and similar CBT-based interventions, when delivered in a traditional in-person format, can improve pain and functioning in people with cancer and other conditions. Yet these interventions are underused in clinical care due to barriers such as high resource costs, a shortage of therapists trained to deliver them, and travel requirements for patients. This trial aims to deliver evidence-based behavioral pain interventions such as PCST with methods capable of overcoming barriers currently limiting patient access. This will be investigated using a two-arm trial comparing pain relief with the following interventions: painTRAINER in clinic with eight web-based follow-up sessions; enhanced usual care.
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.
3UH3CA261067-05S1
Optimizing the use of ketamine to reduce chronic postsurgical pain Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCI NEW YORK UNIVERSITY WANG, JING (contact); DOAN, LISA New York, NY 2024
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-20-272
3U24TR004315-03S1
HEAL ERN: Data Coordinating Resource Center Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS UNIVERSITY OF UTAH WATT, KEVIN M (contact); DWYER, JAMIE P; SWARD, KATHERINE ANN Salt Lake City, UT 2024
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-20-272
3U24TR004316-03S1
Johns Hopkins Statistical and Safety Resource Center-HEAL PAIN ERN Clinical Research in Pain Management Pain Management Effectiveness Research Network (ERN) NCATS JOHNS HOPKINS UNIVERSITY HANLEY, DANIEL F Baltimore, MD 2024
NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-20-272