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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 below
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I speak English or Spanish.
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I have been on in-center hemodialysis for at least 90 days.
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My pain affects my daily life significantly.
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I am 18 years old or older.
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I experience chronic pain most days or every day.

HOPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 12, 24, and 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 12, 24, and 36 for reporting.

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 more

HOPE 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
856 Previous Clinical Trials
671,549 Total Patients Enrolled
9 Trials studying Chronic Pain
1,086 Patients Enrolled for Chronic Pain
Durham VA Health Care SystemFED
6 Previous Clinical Trials
66,972 Total Patients Enrolled

Media Library

Buprenorphine (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04571619 — Phase 2
Chronic Pain Research Study Groups: Pain Coping Skills Training, Usual Care, Buprenorphine, No Buprenorphine
Chronic Pain Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT04571619 — Phase 2
Buprenorphine (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04571619 — Phase 2
Chronic Pain Patient Testimony for trial: Trial Name: NCT04571619 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants being recruited for this trial?

"That is correct. According to the clinicaltrials.gov page, this research initiative was initially posted on March 1st 2021 and updated lastly on October 4th 2022. This trial requires 640 patients from 16 different locations for participation."

Answered by AI

How many medical centers are actively participating in this experimental program?

"VA NY Harbor Healthcare System in New york, University of Pennsylvania located in Philadelphia, and Rogosin Institute situated in Albuquerque are amongst the 17 authorised medical facilities approved to enrol patients for this trial."

Answered by AI

Does the use of Buprenorphine pose any considerable health risks?

"The safety of Buprenorphine was assessed as a 2 due to the Phase 2 status, indicating that while some data is available on it being safe there is none currently suggesting efficacy."

Answered by AI

Is enrollment in this clinical trial still open to qualified participants?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical study, which was initially posted on March 1st 2021, is actively looking for participants. Approximately 640 patients need to be enrolled from 16 diverse trial locations."

Answered by AI

What precedent has been set by prior research related to Buprenorphine?

"At present, 40 clinical trials are exploring the efficacy of buprenorphine. 11 of these studies have moved into late-stage testing, and 220 sites across the globe are participating in this research. The majority of these investigations take place within Durham, North carolina."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
Nebraska
What site did they apply to?
University of Illinois at Chicago
Massachusetts General Hospital
Other
Hennepin County Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

Trying to find something for my pain. Previous box referred to trying something other than tramadol that might work better….
PatientReceived 2+ prior treatments
I've been prescribed several different medications, tried meditation, stretching exercises to no avail. My quality of life has been negatively affected, and desperately need help.
PatientReceived no prior treatments
.I'm a good candidate for the study I am. Opioid dependent and suffer from back and sciatica pain.I want to better my life and if volunteering for a study can help better someone else's life as well it would be very rewarding . and I like helping and volunteering for the study will make me feel I've done something good. Most of all being free of the opiate addiction would be a tremendous blessing in my life and my family's life.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Will I have to take tramadol the rest of my life? How long of a wait is there before I should receive a response?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis
2021. "HOPE Consortium Trial to Reduce Pain and Opioid Use in Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04571619.
All > Opioid Dependence > Probuphine
~151 spots leftby Apr 2025
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