Vanderbilt Clinical Trials

HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

Purpose

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.

Conditions

End Stage Renal Disease
Chronic Pain
Opioid Dependence

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

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

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential multiple assignment design with a randomized component followed by a non-randomized component
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Pain Coping Skills Training	The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.	Behavioral: Pain Coping Skills Training (PCST) The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish. Drug: Buprenorphine At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.
Other Usual Care	Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.	Drug: Buprenorphine At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be encouraged to switch from their current full agonist opioid medication to the partial opioid agonist, buprenorphine. Participants who switch to Buprenorphine will be provided with individualized buprenorphine treatment recommendations. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants who do not meet the Phase 2 eligibility criteria will not be offered buprenorphine. All participants will continue to be followed from Week 24 until Week 36 for ascertainment of pain, opioid use, and other outcomes to address durability of the effects of PCST, and, for those who switch to buprenorphine, to assess buprenorphine acceptability, tolerability, and efficacy as exploratory outcomes.

More Details

Status: Completed
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)