The Helping to End Addiction Long-term (HEAL) Initiative conducted the Hemodialysis Pain Reduction Effort (HOPE) Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis study which was a multicenter randomized clinical trial that evaluated approaches to reducing pain and opioid use among patients with chronic pain who were receiving maintenance hemodialysis for end-stage kidney disease. The trial hypothesis was that pain coping skills training, a cognitive behavioral therapy intervention, would be effective at reducing pain interference, opioid use, and other pain-related outcomes, and that buprenorphine would be acceptable and tolerable as an approach to managing physical dependence on opioids in this patient population. Participants were recruited from participating dialysis clinics at enrolling sites. Eligible participants were randomized to Pain Coping Skills Training (PCST) or Usual Care for 24 weeks, followed by an exploratory, nonrandomized evaluation of buprenorphine as an alternative to full-agonist opioid medications for the subset of participants receiving opioid medication at 20 morphine milligram equivalents per day or higher at Week 24. PCST consisted of 12 weeks of weekly coach-led sessions delivered by videoconferencing and an additional 12 weeks of daily interactive voice response sessions by telephone. Participants were followed in the study for 36 weeks after randomization.

The primary objective was to evaluate the effectiveness of pain coping skills training compared with usual care for reducing pain interference, improving other pain-associated outcomes including pain intensity, depression, anxiety, pain catastrophizing, and quality of life, and reducing opioid use among participants with end-stage renal disease receiving treatment with maintenance hemodialysis.

The secondary objective was to explore acceptability, tolerability, and efficacy of buprenorphine in a subgroup of trial participants prescribed moderate to high-dose long-term opioid therapy for chronic pain.

The primary outcome measure was pain interference as measured by the Brief Pain Index (BPI) Interference Scale. The secondary outcome measures included pain intensity as measured by the BPI Severity Scale, opioid use using morphine milligram equivalent per day (MME/day), fall events, rates of hospitalizations and deaths, buprenorphine acceptability and tolerability, and measures of quality of life, physical functioning, depression, anxiety, coping, sleep, fatigue, treatment satisfaction, social support, family intrusion, discrimination, self-efficacy, and other symptom severity.

• Age ≥ 18 years
• Undergoing in-center maintenance hemodialysis for ≥ 90 days
• English- or Spanish-speaking and provide informed consent
• Chronic pain defined as a response of “Most days” or “Every day” to the following question: “In the past month, how often have you had pain?” Answer options: Never, Some days, Most days, Every day
• Current Pain, Enjoyment, and General Activity (PEG) score ≥ 4
• Willing to allow research team to obtain opioid pharmacy refill data and work with their opioid prescriber

• Current opioid use disorder, heroin, methadone, buprenorphine, or naltrexone for opioid use disorder
• Current non-opioid substance use disorder with the exception of tobacco use disorder
• Current receipt of hospice care or life expectancy < 6 months
• Current incarceration
• Active suicidal intent, or unstable bipolar disorder, schizophrenia, post-traumatic stress disorder, or other psychotic disorder
• Expected to receive a kidney transplant, transfer to another dialysis facility, or transition to home dialysis within 6 months
• Cognitive impairment or any other condition that precludes trial participation

In this randomized clinical trial of adults receiving maintenance hemodialysis, there was a statistically significant, beneficial effect of PCST compared with usual clinical care on pain interference as measured by the Brief Pain Inventory Interference subscale at 12 weeks. The effect persisted at 24 weeks but was attenuated at 36 weeks. There were also statistically significant benefits for secondary outcomes including depression, anxiety, pain catastrophizing, and quality of life. There was not a difference between groups regarding falls, hospitalizations, or death, and there was not an effect on opioid use for the subset of participants using opioids at baseline.