Trial · NCT04571619

HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

NCT04571619, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2025-01-13

3 sourcestrials-2026-11-12-0.4.0

Download JSON

Cite this record

ConductScience Library. HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis. Trials, record NCT04571619. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04571619

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
NCT number: NCT04571619
Status: Completed
Phases: Phase 2
Enrollment: 643 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: End Stage Renal Disease, Chronic Pain, Opioid Dependence
Interventions: Pain Coping Skills Training (PCST), Buprenorphine
First posted: 2020-10-01
Last updated: 2025-01-13
Results first posted: 2025-01-13

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Pain Interference	The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.	Pain interference as measured by the Brief Pain Index (BPI) Interference Scale. This is typically scored as the mean of the seven items. Lowest score - 0; Highest score - 10. A higher score is worse.
Secondary	Pain Intensity	Weeks 12, 24, and 36	Pain intensity as measured by the Brief Pain Index (BPI) Severity Scale. Lowest score - 0; Highest score - 40. A higher score is worse.
Secondary	Pain Catastrophizing	Weeks 12, 24, and 36	Pain catastrophizing will be measured using the Pain Catastrophizing Scale (PCS) Short Form (SF) 6. Lowest score - 0; Highest score - 24. A higher score is worse.
Secondary	Opioid Use	Weeks 12, 24, and 36	Morphine milligram equivalent per day (MME/day). A lower MME is better as this indicates less prescription opioid drug use. Lowest score: 0; Highest score: N/A
Secondary	Number of Falls	Throughout the 36-week follow-up	Number of fall events per arm.
Secondary	Rate of Falls	Though Week 36 follow-up	Event rate as calculated by number of falls/patient years
Secondary	Number of Hospitalizations	Through 36-week follow-up	Number of hospitalizations per arm.
Secondary	Rate of Hospitalizations	Through Week 36 follow-up	Event rate as calculated by number of hospitalizations/patient years
Secondary	Number of Deaths	Through the 36-week follow-up	The number of deaths per arms.
Secondary	Rate of Deaths	Through Week 36 follow-up	Rate of deaths as calculated by number of events/patient years

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Pain Interference	The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.	Participants withdrew at various points during the trial. Some participants were not able to complete the PRO assessments.	score on a scale	MEAN
SECONDARY	Pain Intensity	Weeks 12, 24, and 36	Participants withdrew at various points during the study. Some participants were not able to complete the PRO assessments.	score on a scale	MEAN
SECONDARY	Pain Catastrophizing	Weeks 12, 24, and 36	Participants withdrew at various points throughout the study, and some participants were unable to complete the PRO assessments.	score on a scale	MEAN
SECONDARY	Opioid Use	Weeks 12, 24, and 36	Not all participants reported opioid use, as this was not an inclusion criterion but rather a subset of the study population. This outcome was assessed only for those participants reporting opioid use at the time of enrollment.	morphine milliequivalents	MEAN
SECONDARY	Number of Falls	Throughout the 36-week follow-up		number of falls	NUMBER
SECONDARY	Rate of Falls	Though Week 36 follow-up		falls/patient year	NUMBER
SECONDARY	Number of Hospitalizations	Through 36-week follow-up		hospitalizations	NUMBER
SECONDARY	Rate of Hospitalizations	Through Week 36 follow-up		hospitalizations/patient year	NUMBER
SECONDARY	Number of Deaths	Through the 36-week follow-up		deaths	NUMBER
SECONDARY	Rate of Deaths	Through Week 36 follow-up		deaths/patient year	NUMBER

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group150

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Pain Interference	Pain Coping Skills Training	Baseline	6.26	Standard Deviation 2.02	score on a scale
Pain Interference	Usual Care	Baseline	6.45	Standard Deviation 2.13	score on a scale
Pain Interference	Pain Coping Skills Training	Week 12	5.09	Standard Deviation 2.37	score on a scale
Pain Interference	Usual Care	Week 12	5.75	Standard Deviation 2.55	score on a scale
Pain Intensity	Pain Coping Skills Training	Baseline	5.83	Standard Deviation 2.05	score on a scale
Pain Intensity	Usual Care	Baseline	5.98	Standard Deviation 2.13	score on a scale
Pain Intensity	Pain Coping Skills Training	Week 12	4.95	Standard Deviation 2.32	score on a scale
Pain Intensity	Usual Care	Week 12	5.38	Standard Deviation 2.24	score on a scale
Pain Intensity	Pain Coping Skills Training	Week 24	4.64	Standard Deviation 2.44	score on a scale
Pain Intensity	Usual Care	Week 24	5.21	Standard Deviation 2.31	score on a scale

1 to 10 of 150Source ClinicalTrials.gov

See all 150 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1	STARTED	Pain Coping Skills Training (PCST)	319
Phase 1	STARTED	Usual Care	324
Phase 1	COMPLETED	Pain Coping Skills Training (PCST)	290
Phase 1	COMPLETED	Usual Care	304
Phase 1	NOT COMPLETED	Pain Coping Skills Training (PCST)	29
Phase 1	NOT COMPLETED	Usual Care	20
Phase 2	STARTED	Pain Coping Skills Training (PCST)	290
Phase 2	STARTED	Usual Care	304
Phase 2	COMPLETED	Pain Coping Skills Training (PCST)	271
Phase 2	COMPLETED	Usual Care	284

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events472

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Withdrawal symptoms	General disorders	Pain Coping Skills Training	1	319
other	Withdrawal symptoms	General disorders	Usual Care	5	324
other	Suicidal ideation	Psychiatric disorders	Pain Coping Skills Training	11	319
other	Suicidal ideation	Psychiatric disorders	Usual Care	19	324
other	Adverse effect from a medication starting to treat pain, depression or anxiety	General disorders	Pain Coping Skills Training	11	319
other	Adverse effect from a medication starting to treat pain, depression or anxiety	General disorders	Usual Care	9	324
other	Fall	Injury, poisoning and procedural complications	Pain Coping Skills Training	84	319
other	Fall	Injury, poisoning and procedural complications	Usual Care	94	324
other	Opioid use disorder	Psychiatric disorders	Pain Coping Skills Training	0	319
other	Opioid use disorder	Psychiatric disorders	Usual Care	0	324

1 to 10 of 472Source ClinicalTrials.gov

See all 472 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pain Coping Skills Training	35	319
Total, all-cause mortality	Usual Care	34	324
Total, other adverse events	Pain Coping Skills Training	102	319
Total, other adverse events	Usual Care	115	324
Total, serious adverse events	Pain Coping Skills Training	169	319
Total, serious adverse events	Usual Care	167	324

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
38086444	DERIVED	PubMed
39627496	DERIVED	PubMed
39786400	DERIVED	PubMed
42526778	DERIVED	PubMed

Grants9

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01DK123813	UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis	DEMBER, LAURA M; FARRAR, JOHN T; HSU, JESSE YENCHIH; KAMPMAN, KYLE MATTHEW	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019 to 2024	NIH RePORTER
U01DK123786	Randomized ESRD Trial COmparing CBT alone VERsus with buprenorphine (RECOVER)	MEHROTRA, RAJNISH; CUKOR, DANIEL; UNRUH, MARK LYNN	UNIVERSITY OF WASHINGTON	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019 to 2022	NIH RePORTER
U01DK123787	University of Illinois at Chicago Hemodialysis Opioid Prescription Effort (HOPE) Clinical Center	FISCHER, MICHAEL J.; DOORENBOS, ARDITH Z	UNIVERSITY OF ILLINOIS AT CHICAGO	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019 to 2020	NIH RePORTER
U01DK123812	Creating a multi-level intervention to reduce stigma for buprenorphine use for individuals with End Stage Kidney Disease (ESKD) and Chronic Pain	JHAMB, MANISHA; LIEBSCHUTZ, JANE M; STEEL, JENNIFER L.; YABES, JONATHAN G	UNIVERSITY OF PITTSBURGH AT PITTSBURGH	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019 to 2020	NIH RePORTER
U01DK123814	Pain, Opioids, and ESRD risk reduction with Mindfulness and Buprenorphine (POEM-B): A 3-arm multi-site randomized trial in hemodialysis patients	CHARYTAN, DAVID M; LEE, JOSHUA D; SHALLCROSS, AMANDA J	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019	NIH RePORTER
U01DK123816	The Hemodialysis Opioid Prescription Effort Consortium	JOHANSEN, KIRSTEN L.; BART, GAVIN; KREBS, ERIN ELIZABETH; LIU, JIANNONG	HENNEPIN HEALTHCARE RESEARCH INSTITUTE	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019	NIH RePORTER
U01DK123817	Video-Telecare Collaborative Pain Management to Improve Function and Reduce Opioid Risk in Patients with End Stage Renal Disease Receiving Hemodialysis	BECKER, WILLIAM C; CROWLEY, SUSAN T; ESSERMAN, DENISE; HEAPY, ALICIA	YALE UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019	NIH RePORTER
U01DK123818	Reducing Chronic Pain and Opioid Use in Hemodialysis Patients	KALIM, SAHIR; NIGWEKAR, SAGAR	MASSACHUSETTS GENERAL HOSPITAL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019	NIH RePORTER
U01DK123821	Vanderbilt-West Virginia (VWV) Collaborative: A HOPE Consortium Clinical Center	CAVANAUGH, KERRI	VANDERBILT UNIVERSITY MEDICAL CENTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2019	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pain Coping Skills Training vs Usual Care: deaths from any cause	Trial comparisons
Pain Coping Skills Training vs Usual Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04571619

GET https://conductscience.org/api/trials/v1/NCT04571619/registered?page=2

API reference For AI assistants