HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

PHASE2CompletedINTERVENTIONAL
Enrollment

643

Participants

Timeline

Start Date

January 3, 2021

Primary Completion Date

December 21, 2023

Study Completion Date

May 31, 2024

Conditions
End Stage Renal DiseaseChronic PainOpioid Dependence
Interventions
BEHAVIORAL

Pain Coping Skills Training (PCST)

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.

DRUG

Buprenorphine

At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.

Trial Locations (16)

10010

New York University, New York

VA NY Harbor Healthcare System, New York

10021

Rogosin Institute, New York

15213

University of Pittsburgh, Pittsburgh

19104

University of Pennsylvania, Philadelphia

26506

West Virginia University, Morgantown

27705

Durham VA Healthcare System, Durham

37232

Vanderbilt University Medical Center, Nashville

55415

Hennepin County Medical Center, Minneapolis

60612

University of Illinois at Chicago, Chicago

75216

Dallas VA Medical Center, Dallas

87131

University of New Mexico, Albuquerque

97239

VA Portland Healthcare System, Portland

98104

University of Washington, Seattle

06516

West Haven VA Healthcare System, West Haven

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Hennepin Health Care

UNKNOWN

collaborator

New York University

OTHER

collaborator

Massachusetts General Hospital

OTHER

collaborator

University of Illinois at Chicago

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

University of Washington

OTHER

collaborator

University of New Mexico

OTHER

collaborator

Rogosin Institute

UNKNOWN

collaborator

Vanderbilt University Medical Center

OTHER

collaborator

West Virginia University

OTHER

collaborator

Yale University

OTHER

collaborator

Durham VA Health Care System

FED

collaborator

VA Portland Healthcare System

UNKNOWN

collaborator

West Haven VA Medical Center

UNKNOWN

collaborator

University of Pennsylvania

OTHER

collaborator

Dallas VA Medical Center

FED

collaborator

VA New York Harbor Healthcare System

FED

lead

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

NIH