drugset / Trial / NCT04571619
HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
Phase 2
Completed
643 enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Dallas VA Medical Center · collabDurham VA Health Care System · collabHennepin Health Care · collabMassachusetts General Hospital · collabNew York University · collabRogosin Institute · collabUniversity of Illinois at Chicago · collabUniversity of New Mexico · collabUniversity of Pennsylvania · collabUniversity of Pittsburgh · collabUniversity of Washington · collabVA New York Harbor Healthcare System · collabVA Portland Healthcare System · collabVanderbilt University Medical Center · collabWest Haven VA Medical Center · collabWest Virginia University · collabYale University · collab
RandomizedSequentialOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-01-03
- Primary completion
- 2023-12-21
- Completion
- 2024-05-31
Outcome
Met primary endpoint
paper At week 12 (primary end point), the PCST group had a larger reduction in the BPI Interference score than the usual care group PMID 39786400 ↗
paper between-group difference, -0.49; 95% CI, -0.85 to -0.12; P = .009 PMID 39786400 ↗
Publications
- Dember LM, Hsu JY, Mehrotra R, Cavanaugh KL, Kalim S, Charytan DM, Fischer MJ, Jhamb M, Johansen KL, Becker WC, Pellegrino B, Eneanya ND, Schrauben SJ, Pun PH, Unruh ML, Morasco BJ, Mehta M, Miyawaki N, Penfield J, Bernardo L, Brintz CE, Cheatle MD, Doorenbos AZ, Heapy AA, Keefe FJ, Krebs EE, Kuzla N, Nigwekar SU, Schmidt RJ, Steel JL, Wetmore JB, White DM, Kimmel PL, Cukor D; HOPE Consortium. Pain Coping Skills Training for Patients Receiving Hemodialysis: The HOPE Consortium Randomized Clinical Trial. JAMA Intern Med. 2025 Feb 1;185(2):197-207. doi: 10.1001/jamainternmed.2024.7140.
- Steel JL, Brintz CE, Heapy AA, Keefe F, Cheatle MD, Jhamb M, McNeil DW, Shallcross AJ, Kimmel PL, Dember LM, White DM, Williams J, Cukor D. Adapting a pain coping skills training intervention for people with chronic pain receiving maintenance hemodialysis for end stage Kidney disease. J Behav Med. 2025 Apr;48(2):298-307. doi: 10.1007/s10865-024-00534-x. Epub 2024 Dec 3.
- Dember LM, Hsu JY, Bernardo L, Cavanaugh KL, Charytan DM, Crowley ST, Cukor D, Doorenbos AZ, Edwards DA, Esserman D, Fischer MJ, Jhamb M, Joffe S, Johansen KL, Kalim S, Keefe FJ, Kimmel PL, Krebs EE, Kuzla N, Mehrotra R, Mishra P, Pellegrino B, Steel JL, Unruh ML, White DM, Yabes JG, Becker WC; HOPE Consortium. The design and baseline characteristics for the HOPE Consortium Trial to reduce pain and opioid use in hemodialysis. Contemp Clin Trials. 2024 Jan;136:107409. doi: 10.1016/j.cct.2023.107409. Epub 2023 Dec 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | — | — |