Funded Projects

Project # Project Title Sort descending Research Focus Area Research Program Administering IC(s) Institution(s) Investigator(s) Location(s) Year Awarded
3U01DK123812-01S1
Creating a multi-level intervention to reduce stigma for buprenorphine use for individuals with End Stage Kidney Disease and Chronic Pain Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF PITTSBURGH AT PITTSBURGH JHAMB, MANISHA Pittsburgh, PA 2020
FOA Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
FOA Number: NOT-OD-20-101
Summary:

Medications have proven to be effective for treating opioid use disorder (OUD). Increasing accessibility to buprenorphine provides an opportunity for many with OUD to benefit from its proven effectiveness. Adherence to medication-based treatments however is low, in part because of the stigma associated with use of this and other effective drugs and as such, leads to inadequate treatment and poor outcomes. This study aims to understand the effects of stigma on patient engagement, retention, and outcomes of buprenorphine treatment. Knowledge drawn from the HIV Stigma Theory and tools developed to reduce HIV associated stigma will be used to assess OUD stigma and to develop interventions to reduce it in the context of buprenorphine treatment. The study findings may provide resources to address stigma and thus maximize treatment adherence among those affected by OUD.

1U01DK123812-01
Pain Reduction and Opioid MedIcation Safety in ESRD (PROMISE) study Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF PITTSBURGH AT PITTSBURGH JHAMB, MANISHA; LIEBSCHUTZ, JANE M; STEEL, JENNIFER L; YABES, JONATHAN G Pittsburgh, PA 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

The Pain Reduction and Opioid Medication Safety in ESRD (PROMISE) study aims to improve the safety of opioid use and pain management in end-stage renal disease (ESRD) patients on hemodialysis (HD) using a Type I effectiveness-implementation hybrid design. A multisite randomized controlled trial of HD patients from the Hemodialysis Opioid Prescription Effort (HOPE) Consortium will examine the effectiveness of two separate nine-month evidence-based interventions: 1) Opioid Tapering Management (OTM) and 2) Behavioral Pain Management (BPM). We will examine the effectiveness of OTM (versus no OTM, Aim 1) and BPM (versus no BPM) over nine months for reducing opioid use (primary outcome) and improving pain severity (secondary outcome) in HD patients on chronic opioids. The implementation goal will take advantage of the diverse patient, provider, and organizational settings in the HOPE Consortium to evaluate process outcomes.

1U01DK123814-01
Pain, Opioids, and ESRD risk reduction with Mindfulness and Buprenorphine (POEM-B): A 3-arm multi-site randomized trial in hemodialysis patients Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK NEW YORK UNIVERSITY SCHOOL OF MEDICINE CHARYTAN, DAVID M; GOLDFELD, KEITH ; LEE, JOSHUA D; SHALLCROSS, AMANDA J New York NY 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

In this study, 600 to 700 hemodialysis patients receiving chronic opioids will be randomized across the Hemodialysis Opioid Prescription Effort (HOPE) Consortium to enhanced treatment as usual, buprenorphine therapy, or buprenorphine plus mindfulness-based cognitive therapy intervention delivered by telephone and adapted for pain (MBCT-TP). The following specific aims will be assessed: Aim 1—to assess the effectiveness of buprenorphine in reducing chronic opioid use and prescriptions in hemodialysis patients on opioids at baseline, compared with an enhanced treatment as usual intervention and to assess the effectiveness of buprenorphine in improving pain intensity, quality of life measures, and hospitalizations; Aim 2—to assess the incremental effectiveness of MBCT-TP added to buprenorphine compared with buprenorphine alone on pain interference with physical, social, and mental functioning, opioid use, pain intensity, other quality of life measures, hospitalizations, and mortality.

1U01DK123786-01
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; CUKOR, DANIEL ; UNRUH, MARK LYNN Seattle, WA 2019
FOA 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)
FOA 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.

1U01DK123818-01
Reducing Chronic Pain and Opioid Use in Hemodialysis Patients Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK MASSACHUSETTS GENERAL HOSPITAL KALIM, SAHIR; NIGWEKAR, SAGAR Boston, MA 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

Because pain is a multidimensional phenomenon with physical and psychosocial components, a pain management approach relying solely on analgesics is unlikely to be efficacious. Nonpharmacologic therapies for co-occurring chronic pain and opioid use in hemodialysis patients should target and alter cognitive-affective circuits that govern responses elicited by pain, stress, mood disorders, and opioid-related cues. These domains are directly addressed through the behavioral therapy program known as MORE (Mindfulness-Oriented Recovery Enhancement)—a multipronged mindfulness-oriented individualized group therapy that integrates mindfulness training, cognitive reappraisal, and enhancement of natural reward processing. The specific aims are 1) to determine the impact of MORE on chronic pain and opioid use in hemodialysis patients and 2) to determine predictors of chronic pain, opioid use, and response to MORE.

1U01DK123816-01
The Hemodialysis Opioid Prescription Effort Consortium Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK HENNEPIN HEALTHCARE RESEARCH INSTITUTE JOHANSEN, KIRSTEN L; BART, GAVIN ; KREBS, ERIN ELIZABETH; LIU, JIANNONG Minneapolis, MN 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

Despite the pervasive use of opioid analgesics in the dialysis population and the substantial risks they engender, their efficacy is limited in treating common chronic pain conditions. Most patients receiving long-term opioid therapy continue to experience severe pain and functional limitations. To simultaneously address problems related to chronic pain and opioid use in the U.S. hemodialysis population, this study will evaluate tailored patient-centered interventions to manage pain and reduce opioid use. Patients will be assigned randomly to one of three groups over a 12-month study period: 1) pain care management (PCM) versus 2) PCM plus an online pain self-management program (PSM) that incorporates cognitive behavioral training and is delivered during dialysis sessions, versus 3) control with medication review and education. The study will also evaluate the effectiveness of offering buprenorphine by randomly assigning participants in both active treatment arms to being offered buprenorphine rotation versus continued standard opioid taper support without the option of buprenorphine.

3U01DK123787-01S1
University of Illinois at Chicago Hemodialysis Opioid Prescription Effort (HOPE) Clinical Center Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF ILLINOIS AT CHICAGO FISCHER, MICHAEL J. Chicago, IL 2020
FOA 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)
FOA Number: NOT-NS-20-044
Summary:

It is increasingly clear that the microbiome influences psychoneurological symptoms, including pain. This project will support clinical research training focused on examining the relationship between the composition and function of the gut microbiome, including the symbiotic bacteria residing in the gut and their functional gene content, and chronic pain among adults with end-stage kidney disease (ESKD). It provides an opportunity for the trainee to expand his skill set as a pain investigator, through experience in implementing and evaluating pain management interventions in adults with ESKD and chronic pain receiving maintenance hemodialysis. The project aims to determine the acceptability of collecting feces and the feasibility of fecal data collection procedure to determine the best strategies for recruiting research participants from multiple dialysis facilities. These steps will allow the exploration of gene content of the gut microbiota and short-chain fatty acids among people with ESKD on maintenance hemodialysis before and after pain management interventions.

1U01DK123787-01
University of Illinois at Chicago Hemodialysis Opioid Prescription Effort (HOPE) Clinical Center Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF ILLINOIS AT CHICAGO FISCHER, MICHAEL J; DOORENBOS, ARDITH Z Chicago, IL 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

This study will evaluate novel strategies to reduce opioid use and pain in patients with end-stage renal disease receiving chronic hemodialysis (HD). Specifically, the study will examine the effect of nonpharmacologic (Acceptance and Commitment Therapy [ACT] and acupuncture) and pharmacologic (buprenorphine) interventions in HD patients who are receiving chronic opioid medications due to chronic pain and/or high pain interference. The study will enroll 720 HD patients across U.S. Hemodialysis Opioid Prescription Effort Consortium Clinical Centers to (1) determine the effectiveness of ACT and acupuncture compared with the control condition in reducing opioid dose and improving pain among HD patients; (2) identify the best adaptive intervention sequence for improved outcomes; (3) explore age, sex, and comorbidities as potential moderators of the response to the intervention; and (4) describe facilitators and barriers to the implementation of the intervention using in-depth, semi-structured individual interviews with intervention participants and providers.

1U01DK123813-01
UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK UNIVERSITY OF PENNSYLVANIA DEMBER, LAURA M; FARRAR, JOHN T; KAMPMAN, KYLE MATTHEW; LANDIS, J RICHARD Philadelphia, PA 2019
FOA Title: HEAL Initiative: Integrated Approach to Pain and Opioid Use in Hemodialysis Patients: The Hemodialysis Opioid Prescription Effort (HOPE) Consortium - Scientific and Data Research Center (U01 Clinical Trial Required)
FOA Number: RFA-DK-18-031
Summary:

The University of Pennsylvania Perelman School of Medicine serves as the Scientific and Data Research Center (SDRC) for the Hemodialysis Opioid Prescription Effort (HOPE) Consortium. Specifically, the SDRC will 1) provide scientific leadership for the HOPE Consortium clinical trial; 2) provide comprehensive operational support to the Clinical Centers for implementing the collaboratively designed trial protocol; 3) develop and lead a Stakeholder Engagement Working Group; 4) integrate and analyze data from the electronic health records of the participating Clinical Centers; 5) establish, promote, and maintain consortium-wide high standards for quality assurance and practices; 6) initiate and oversee contracts with industry partners; 7) prepare reports for the Data and Safety Monitoring Board, and support the preparation of Consortium reports of scientific findings; 8) prepare, document, and transfer Consortium data and biosamples to a Central Repository; and 9) develop approaches for disseminating the trial findings to diverse stakeholders.

1U01DK123821-01
Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK VANDERBILT UNIVERSITY MEDICAL CENTER CAVANAUGH, KERRI; EDWARDS, DAVID ALLAN Nashville, TN 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

This study will collaborate with diverse stakeholders to design and conduct a multisite trial evaluating innovative strategies to reduce opioid dosing and improve quality of life and experience with care specific to pain management among adults receiving in-center hemodialysis. A pragmatic parallel arm trial will test the impact of adding a 12-week interactive video cognitive behavioral therapy (IV-CBT) intervention program, compared with CDC guideline-concordant shared decision-making (SDM) for NCCP pharmacotherapy management. The specific aims are to (1) conduct a multisite randomized trial to receive IV-CBT and SDM versus SDM alone over 15 months; (2) investigate and describe barriers and facilitators of the implementation of IV-CBT and also SDM among patients, clinicians, and dialysis staff; and (3) create a collaborative network of investigators and dialysis facilities for efficient recruitment and for dissemination of successful strategies to optimize pain care in dialysis.

1U01DK123817-01
Video-Telecare Collaborative Pain Management to Improve Function and Reduce Opioid Risk in Patients with End Stage Renal Disease Receiving Hemodialysis Clinical Research in Pain Management Integrated Approach to Pain and Opioid Use in Hemodialysis Patients NIDDK YALE UNIVERSITY BECKER, WILLIAM C; CROWLEY, SUSAN T; ESSERMAN, DENISE ; HEAPY, ALICIA New Haven, CT 2019
FOA 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)
FOA Number: RFA-DK-18-030
Summary:

Research on optimal long-term opioid therapy (LTOT) tapering strategies has lagged behind clinical needs. Patients with end-stage renal disease (ESRD) receiving hemodialysis (HD) may be especially vulnerable. This study will adapt the Collaborative Opioid Reassessment Program (CORP) and Cooperative Pain Education and Self-Management (COPES) interventions for patients receiving HD and LTOT and test their effectiveness in a pragmatic sequential multiple assignment randomized trial (SMART) design. Initial randomization will be to compare CORP-supported taper with (CORP-B) and without (CORP) buprenorphine rotation on the six-month composite outcome of LTOT dose reduction and pain response. This design will allow determination of which of the eight adaptive treatment strategies leads to the greatest reduction in six-month opioid dose and pain interference.