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Improving Pain Management and Opioid Safety for Patients With 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 6-12 months start-to-finish
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6-12 months start-to-finish
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
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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
2,594 Previous Clinical Trials
3,328,706 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- The person must be receiving care at a UPMC hepatology clinic.You need to have been experiencing pain for three or more months.
Research Study Groups:
This trial has the following groups:- Group 1: LEAP Intervention Arm
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.