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Liver Education About Pain (LEAP) for Liver Cirrhosis

N/A
Waitlist Available
Led By Shari S Rogal, MD, MPH
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6-12 months start-to-finish
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the LEAP program, a course designed to help patients with liver cirrhosis and chronic pain manage their pain without opioids. The program includes individual and group sessions to teach new pain management skills, set personal goals, and provide social support.

Eligible Conditions
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6-12 months start-to-finish
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6-12 months start-to-finish for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants attending ≥80% of intervention sessions
Overall Satisfaction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LEAP Intervention ArmExperimental Treatment2 Interventions
Enrolled patients will participate in 12 weekly sessions led by a health coach to learn self-pain management tools and skills. In addition to 6 individual sessions and 6 optional group sessions, participants will complete activities from the LEAP workbook (provided after enrollment), as tracking is a key component of most pain-self management interventions and is intended to address self-regulation. All patients can continue to use other pain management strategies ("usual care") in order to mimic real-life conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liver Education About Pain (LEAP)
2022
N/A
~30
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,593 Total Patients Enrolled
4 Trials studying Liver Cirrhosis
30,404 Patients Enrolled for Liver Cirrhosis
National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,500 Total Patients Enrolled
Shari S Rogal, MD, MPHPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
30,300 Total Patients Enrolled
1 Trials studying Liver Cirrhosis
30,300 Patients Enrolled for Liver Cirrhosis

Media Library

Liver Education About Pain (LEAP) Clinical Trial Eligibility Overview. Trial Name: NCT05128578 — N/A
Liver Cirrhosis Research Study Groups: LEAP Intervention Arm
Liver Cirrhosis Clinical Trial 2023: Liver Education About Pain (LEAP) Highlights & Side Effects. Trial Name: NCT05128578 — N/A
Liver Education About Pain (LEAP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128578 — N/A
~8 spots leftby Nov 2025