PCST + Buprenorphine for Chronic Pain in Hemodialysis

(HOPE Trial)

Recruiting at15 trial locations

Overseen by Laura Dember, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

HOPE is a randomized clinical trial that will evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease. The hypothesis is that pain coping skills training will be effective at reducing pain and opioid use, and that buprenorphine will be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population.

Research Team

Laura Dember, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who speak English or Spanish, have chronic pain while on hemodialysis for kidney failure, and are willing to share opioid use data. It's not for those with unstable mental health conditions, current heroin or heavy non-opioid substance abuse, severe cognitive issues, short life expectancy, planned kidney transplant/dialysis changes soon, incarceration, or using certain medications for opioid disorder.

Inclusion Criteria

I speak English or Spanish.

I have been on in-center hemodialysis for at least 90 days.

My pain affects my daily life significantly.

Exclusion Criteria

I am currently using methadone, buprenorphine, or naltrexone for opioid addiction.

Any other condition that the investigator considers precludes participation in the clinical trial

Current incarceration

Treatment Details

Interventions

• Buprenorphine (Opioid Partial Agonist)
• Pain Coping Skills Training (PCST) (Behavioral Intervention)

Trial Overview The HOPE trial is testing if Pain Coping Skills Training (PCST) can help reduce pain and cut down on opioid use in patients with chronic pain undergoing hemodialysis. It also examines whether Buprenorphine is a good option to manage physical dependence on opioids without causing harm.

Participant Groups

Group I: Usual Care Experimental Treatment 1 Intervention

Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.

Group II: Pain Coping Skills Training Active Control 2 Interventions

The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

VA New York Harbor Healthcare System 630

Collaborator

Trials

1

Recruited

640+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Jeffrey R. Balser

Vanderbilt University Medical Center

Chief Executive Officer since 2009

MD and PhD from Vanderbilt University

Rick W. Wright

Vanderbilt University Medical Center

Chief Medical Officer since 2023

MD from University of Missouri-Columbia

Durham VA Health Care System

Collaborator

Trials

8

Recruited

64,900+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Dr. William P. Petros

West Virginia University

Chief Medical Officer

PharmD from West Virginia University

Dr. Clay B. Marsh

West Virginia University

Chief Executive Officer since 2015

MD from West Virginia University, Bachelor’s in Biology from West Virginia University

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School