CM for Patients With ALD After Liver Transplant

NCT06304467 | Active Not Recruiting

• 2 other identifiers: IRB#23-001133UL1TR001881
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Alcohol associated liver disease (ALD) refers to liver injury, such as cirrhosis, that is caused by alcohol use. It affects 2 million adults in the U.S. and is now the leading cause of cirrhosis-related hospitalizations, cirrhosis- related deaths, and liver transplantation. Alcohol use disorder (AUD), the root cause of ALD, affects 15 million Americans each year. While research studies have shown that behavioral therapy and medications specific for alcohol use have helped people overcome their alcohol use disorder, there has not been enough information related to how successful these treatments are specifically for people with ALD. This study will look at a behavioral treatment called "contingency management" (CM) that has shown to be effective with people with other substance use disorders. CM is based on the principles of operant conditioning that involves offering prize-based or monetary incentives to patients with substance use disorders to reduce substance use. This study will look at the efficacy and acceptability of CM in patients who received a liver transplant and have evidence of recurrent alcohol use. The proposed study is a pilot randomized controlled trial of 30 patients with ALD who received a liver transplant; 15 will be randomized to receive a 10-week CM intervention while 15 will receive treatment as usual (TAU or control). Subjects will be asked to complete 12 study visits (including Screening and Baseline Visits) that will last 1 to 2 hours each depending on the visit. All visits will be completed via Zoom or by phone. Study staff will instruct participants on how to use Zoom, if necessary. During the Screening and Baseline Visits, subjects will be: 1) asked to provide a urine test and blood draw, 2) complete the SCID-5 AUD, a semi-structured interview guide for making the major DSM-5 diagnoses, 3) complete the Iowa Gambling Test which looks at decision-making skills, 4) complete a survey that looks at the subject's quality of life after liver transplant, 4) review how much alcohol the subject has consumed in the last 30 days, 5) and if the subject has received any current AUD treatments. Once the Screening and Baseline visits are completed, subjects will be randomized to either the CM group or the TAU group. During the weekly visits, subjects will be asked to provide blood and urine samples and will be asked if they have had any alcohol since their last visit. All subjects will receive $20 for completing the visits. For those in the CM group, subjects will also receive a CM reward for negative urine and/or blood tests, depending on which results we receive first-with rewards ranging from $5 to $80 depending on the week. Additionally, during weeks 1, 5, and 10, those in the CM group will also complete the Client Satisfaction Questionnaire-8 to assess client satisfaction with CM and complete a semi-structured interview about the CM protocol as well as CM acceptability and feasibility.

Conditions

Alcohol Use Disorder; Alcohol; Liver; Post Liver Transplant; Contingency Management; Alcohol Liver Disease

Keywords

Alcohol Liver Disease; Contingency Management; Post Liver Transplant; Alcohol Use Disorder; Post Liver Transplant Drinking

Outcome Measures

Primary Outcomes (1)

• Number of Non-Drinking Days

  The primary outcome for the study is the number of non-drinking days, which will be assessed by objective measures (i.e., presence of alcohol biomarkers in the blood and urine), as well as subjective measures (i.e., Timeline Followback). For the 10-week CM intervention, there will be a maximum of 70 non-drinking days.

  10 Weeks

Secondary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr))

  10 Weeks

• Client Satisfaction Questionnaire-8.

  10 Weeks

Study Arms (2)

Treatment As Usual (TAU)

NO 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. .

Contingency Management (CM)

EXPERIMENTAL

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.

Behavioral: Contingency Management

Interventions

Contingency Management BEHAVIORAL

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.

Contingency Management (CM)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 years of age or older
• Have received a liver transplant
• Has documented return to drinking (subjective or objective) within the past 60 days
• Willing to partake in behavioral treatment for AUD
• Written informed consent and ability for subject to comply with the requirements of the study.

You may not qualify if:

• Current treatment for another substance use disorder
• Unwilling to partake in behavioral treatment for AUD
• Unwilling to provide written informed consent
• Non-English speaking

Sponsors & Collaborators

• Arpan A. Patel, MD: lead

Study Sites (1)

Pfleger Liver Institute

Los Angeles, California, 90095-1406, United States

Location

MeSH Terms

Conditions

Alcoholism; Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders

Study Officials

• Arpan G Patel, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Hepatologist, Assistant Professor, David Geffen School of Medicine at UCLA

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 12, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)