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Opioid Partial Agonist
PCST + Buprenorphine for Chronic Pain in Hemodialysis (HOPE Trial)
Phase 2
Waitlist Available
Led By Laura Dember, MD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
English- or Spanish-speaking
Undergoing in-center maintenance hemodialysis for ≥90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 12, 24, and 36
Awards & highlights
HOPE Trial Summary
This trial will evaluate if pain coping skills training and buprenorphine can help manage pain and reduce opioid use in patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease.
Who is the study for?
This trial is for adults over 18 who speak English or Spanish, have chronic pain while on hemodialysis for kidney failure, and are willing to share opioid use data. It's not for those with unstable mental health conditions, current heroin or heavy non-opioid substance abuse, severe cognitive issues, short life expectancy, planned kidney transplant/dialysis changes soon, incarceration, or using certain medications for opioid disorder.Check my eligibility
What is being tested?
The HOPE trial is testing if Pain Coping Skills Training (PCST) can help reduce pain and cut down on opioid use in patients with chronic pain undergoing hemodialysis. It also examines whether Buprenorphine is a good option to manage physical dependence on opioids without causing harm.See study design
What are the potential side effects?
While the side effects of PCST are minimal as it involves psychological training techniques rather than medication, Buprenorphine may cause nausea, drowsiness, constipation and might be habit-forming. The severity of side effects varies from person to person.
HOPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English or Spanish.
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I have been on in-center hemodialysis for at least 90 days.
Select...
My pain affects my daily life significantly.
Select...
I am 18 years old or older.
Select...
I experience chronic pain most days or every day.
HOPE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 12, 24, and 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 24, and 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain interference
Secondary outcome measures
Anxiety
Buprenorphine acceptability
Buprenorphine tolerability
+18 moreHOPE Trial Design
4Treatment groups
Active Control
Group I: Pain Coping Skills TrainingActive Control1 Intervention
Group II: Usual CareActive Control1 Intervention
Group III: BuprenorphineActive Control1 Intervention
Group IV: No BuprenorphineActive Control1 Intervention
Find a Location
Who is running the clinical trial?
VA New York Harbor Healthcare System 630UNKNOWN
Vanderbilt University Medical CenterOTHER
866 Previous Clinical Trials
671,924 Total Patients Enrolled
9 Trials studying Chronic Pain
1,086 Patients Enrolled for Chronic Pain
Durham VA Health Care SystemFED
7 Previous Clinical Trials
67,122 Total Patients Enrolled
1 Trials studying Chronic Pain
150 Patients Enrolled for Chronic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently using methadone, buprenorphine, or naltrexone for opioid addiction.I speak English or Spanish.I have been on in-center hemodialysis for at least 90 days.My pain affects my daily life significantly.I agree to let the research team access my opioid medication refill records.I am expected to have a kidney transplant or change my dialysis method within 6 months.I am 18 years old or older.You are currently addicted to opioids.Currently having thoughts of hurting oneself.You agree to give permission after being fully informed about the study.You have a mental health condition that is not stable.You are currently using heroin.You are currently addicted to drugs other than tobacco.I do not have any cognitive issues that would stop me from joining the trial.You are not expected to live for more than 6 months.You agree to let the research team work with your doctor who prescribes your opioid medication.I am currently receiving hospice care.I experience chronic pain most days or every day.
Research Study Groups:
This trial has the following groups:- Group 1: Pain Coping Skills Training
- Group 2: Usual Care
- Group 3: Buprenorphine
- Group 4: No Buprenorphine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Pain Patient Testimony for trial: Trial Name: NCT04571619 — Phase 2
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