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Behavioural Intervention
Contingency Management for Post-Liver Transplant in Alcoholic Liver Disease
N/A
Recruiting
Led By Arpan G Patel, MD
Research Sponsored by Arpan A. Patel, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have received a liver transplant
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the effectiveness of a behavioral treatment called 'contingency management' in patients with Alcohol-Associated Liver Disease (ALD) who have received a liver transplant. ALD is
Who is the study for?
This trial is for adults over 18 who have had a liver transplant and returned to drinking alcohol within the last month. They must be willing to undergo behavioral treatment for their alcohol use disorder and able to follow study procedures.
What is being tested?
The study tests 'contingency management' (CM), a behavior therapy offering rewards for staying sober, in patients with alcoholic liver disease post-liver transplant. Half will receive CM for 10 weeks; the other half get usual care. All interactions are via Zoom.
What are the potential side effects?
Since CM involves psychological and social interventions rather than medications, traditional side effects like those seen with drugs are not expected. However, participants may experience stress or anxiety related to adherence to the program's requirements.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a liver transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Non-Drinking Days
Secondary study objectives
Client Satisfaction Questionnaire-8.
Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr))
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Contingency Management (CM)Experimental Treatment1 Intervention
Study subjects who have received a liver transplant and have been randomized to the treatment arm will receive contingency management, a positive reinforcement behavioral treatment with escalating rewards for consecutive either negative urine and blood tests (or lower value of metabolites than the previous week for PeTH) depending on which results are received first, capped at a maximum of $80 (in the form of a gift card) at the week 10 visit.
Group II: Treatment As Usual (TAU)Active Control1 Intervention
Study Subjects randomized to treatment as usual (TAU) will not receive an intervention. They will continue with follow-up visits in the outpatient clinic as part of standard of care. .
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contingency Management
2014
Completed Phase 4
~3440
Find a Location
Who is running the clinical trial?
Arpan A. Patel, MDLead Sponsor
Arpan G Patel, MDPrincipal InvestigatorUniversity of California, Los Angeles