HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of Pennsylvania
• Collaborators: Durham VA Health Care System; Durham VA Healthcare System; Hennepin Health Care; Massachusetts General Hospital; New York University; Rogosin Institute; University of Illinois at Chicago; University of New Mexico; University of Pennsylvania; University of Pittsburgh; University of Washington; VA Portland Healthcare System; Vanderbilt University Medical Center; West Haven VA Medical Center; West Virginia University; Yale University
• Treatments: Buprenorphine

Criteria

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.