HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
CompletedPhase 2NCT04571619
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized Clinical Trial to Evaluate Non-Pharmacologic and Pharmacologic Approaches for Reducing Pain and Opioid Use Among Patients Treated With Maintenance Hemodialysis
- Conditions
- End Stage Renal Disease
- Chronic Pain
- Opioid Dependence
- Interventions
- Behavioral: Pain Coping Skills Training (PCST)
- Drug: Buprenorphine
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Collaborators
- Hennepin Health Care; New York University; Massachusetts General Hospital; University of Illinois at Chicago; University of Pittsburgh; University of Washington; University of New Mexico; Rogosin Institute; Vanderbilt University Medical Center; West Virginia University; Yale University; Durham VA Health Care System; VA Portland Healthcare System; West Haven VA Medical Center; University of Pennsylvania; Dallas VA Medical Center; VA New York Harbor Healthcare System
- Start date
- 2021-01-03
- Primary completion
- 2023-12-21
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 16
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Age ≥ 18 years 2. Undergoing in-center maintenance hemodialysis for ≥90 days 3. English- or Spanish-speaking 4. Chronic pain defined as a response of "Most days" or "Every day" to the following question: "In the past 3 months, how often have you had pain?" Answer options: Never, Some days, Most days, Every day 5. Current Pain, Enjoyment of Life and General Activity Scale (PEG) score ≥ 4 6. Willing to provide informed consent 7. Willing to allow research team to obtain opioid pharmacy refill data 8. Willing to allow research team to contact and work with their opioid prescriber Exclusion Criteria: 1. Current opioid use disorder 2. Current use of heroin 3. Current non-opioid substance use disorder with the exception of tobacco use disorder 4. Current use of methadone, buprenorphine, or naltrexone for opioid use disorder 5. Current receipt of hospice care 6. Cognitive impairment that, in the judgement of the research team, precludes trial participation 7. Active suicidal intent 8. Unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder 9. Life expectancy \< 6 months 10. Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months 11. Current incarceration 12. Any other condition that the investigator considers precludes participation in the clinical trial Subgroup with Current or Recent Opioid Use During eligibility screening all potential participants will have opioid use ascertained using the timeline follow back approach. The trial will enroll at least 300 participants (among the 640 total study participants) with current or recent opioid use defined as patient-reported prescription opioid use during at least 3 of the past 6 months. The number of participants in the opioid use subgroup will be monitored throughout the trial enrollment period. If the rate of enrollment into the opioid use subgroup is lower than targeted, trial enrollment will be restricted to individuals meeting the opioid use criteria as long as necessary to ensure that the total enrollment target for the trial is not met without reaching the opioid use subgroup target.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04571619