Clinical trial NCT04571619: HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Chronic Pain
Opioid Dependence
Keywords: hemodialysis
pain
opioids
pain coping skills
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Hennepin Health Care
name: New York University
name: Massachusetts General Hospital
name: University of Illinois at Chicago
name: University of Pittsburgh
name: University of Washington
name: University of New Mexico
name: Rogosin Institute
name: Vanderbilt University Medical Center
name: West Virginia University
name: Yale University
name: Durham VA Health Care System
name: VA Portland Healthcare System
name: West Haven VA Medical Center
name: University of Pennsylvania
name: Dallas VA Medical Center
name: VA New York Harbor Healthcare System
First posted: 2020-10-01
Enrollment: 643
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential multiple assignment design with a randomized component followed by a non-randomized component
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Pain Interference
timeFrame: The primary outcome of pain interference will be ascertained at Week 12 coinciding with the end of the PCST weekly coaching sessions.
Secondary outcomes:
measure: Pain Intensity
timeFrame: Weeks 12, 24, and 36
measure: Pain Catastrophizing
timeFrame: Weeks 12, 24, and 36
measure: Opioid Use
timeFrame: Weeks 12, 24, and 36
measure: Number of Falls
timeFrame: Throughout the 36-week follow-up
measure: Rate of Falls
timeFrame: Though Week 36 follow-up
measure: Number of Hospitalizations
timeFrame: Through 36-week follow-up
measure: Rate of Hospitalizations
timeFrame: Through Week 36 follow-up
measure: Number of Deaths
timeFrame: Through the 36-week follow-up
measure: Rate of Deaths
timeFrame: Through Week 36 follow-up
measure: Buprenorphine Acceptability
timeFrame: Through Week 36
measure: Buprenorphine Tolerability
timeFrame: Through Week 36
measure: Overall Sense of Quality of Life
timeFrame: Weeks 12, 24, and 36
measure: Physical Functioning
timeFrame: Weeks 12, 24, and 36
measure: Depression
timeFrame: Weeks 12, 24, and 36
measure: Anxiety
timeFrame: Weeks 12, 24, and 36
measure: Coping
timeFrame: Weeks 12, 24, and 36
measure: Sleep Quality
timeFrame: Weeks 12, 24, and 36
measure: Fatigue
timeFrame: Weeks 12, 24, and 36
measure: Satisfaction With Treatment
timeFrame: Weeks 12, 24, and 36
measure: Social Support
timeFrame: Weeks 12, 24, and 36
measure: Family Intrusion
timeFrame: Weeks 12, 24, and 36
measure: Self-Efficacy
timeFrame: Weeks 12, 24, and 36
measure: Presence of Other Symptoms
timeFrame: Weeks 12, 24, and 36
measure: Severity of Other Symptoms
timeFrame: Week 12, 24, 36
measure: Discrimination
timeFrame: Baseline, Week 36
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven VA Healthcare System
state: Connecticut
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System
state: New York
city: New York
country: United States
facility: Rogosin Institute
state: New York
city: Durham
country: United States
facility: Durham VA Healthcare System
state: North Carolina
city: Portland
country: United States
facility: VA Portland Healthcare System
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Pennsylvania
name: Laura Dember, MD
role: PRINCIPAL_INVESTIGATOR
References: