HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Chronic Pain; End Stage Renal Disease; Opioid Dependence

Treatments: Drug: Buprenorphine; Behavioral: Pain Coping Skills Training (PCST)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT04571619

U01DK123786 (U.S. NIH Grant/Contract)

U01DK123812 (U.S. NIH Grant/Contract)

U01DK123814 (U.S. NIH Grant/Contract)

U01DK123787 (U.S. NIH Grant/Contract)

HOPE

U01DK123813 (U.S. NIH Grant/Contract)

U01DK123818 (U.S. NIH Grant/Contract)

U01DK123817 (U.S. NIH Grant/Contract)

U01DK123816 (U.S. NIH Grant/Contract)

U01DK123821 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 643 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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643 participants in 2 patient groups

Pain Coping Skills Training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Pain Coping Skills Training (PCST)

Drug: Buprenorphine

Usual Care

Other group

Description:

Participants in the Usual Care arm will be provided with written educational material about chronic pain and opioid medications, and available resources for treatment.

Treatment:

Drug: Buprenorphine