Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05128578 |
Other study ID # |
STUDY21080148 |
Secondary ID |
1K23DA048182-01A |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 14, 2022 |
Est. completion date |
October 21, 2023 |
Study information
Verified date |
October 2023 |
Source |
University of Pittsburgh |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This project aims to test a behavioral intervention in patients with liver cirrhosis and
chronic pain and teach self pain-management skills.
Description:
Prescription opioid medications are a leading cause of opioid-related death and are
particularly risky in patients with cirrhosis of the liver, which affects 4 million people in
the US. In this population, prescription opioids are associated with complications of liver
disease, decreased access to life-saving transplantation, and increased hospitalization,
post-transplant mortality, and all-cause mortality. Moreover, most patients with cirrhosis
have underlying alcohol and/or substance use disorders (SUDs), which increase the risk of
opioid-related complications and misuse. Despite these risks, our pilot work found that
nearly half of all patients with cirrhosis are prescribed opioid medications each year and
that these prescriptions are often inconsistent with opioid prescribing safety guidelines.
One potential reason for this may be the lack of safe, evidence-based, alternative pain
management strategies for this patient population. Indeed, existing opioid safety and pain
management interventions designed for general populations do not address many of the specific
issues facing patients with cirrhosis.
The research team plans to recruit patients at UPMC for participation in the Liver Education
About Pain (LEAP) intervention program. LEAP is a modular 12-week pain self-management
intervention with individual and group sessions. Individual sessions serve the purpose of
individualizing the program to the needs of the patients. Group sessions allow participants
to practice skills, set goals with the group, seek social support, and learn together. The
purpose of the LEAP program is to make pain better, help patients reach their personal goals
(things that may be hard to do because of pain), and add to the care patients' medical team
is providing.