protocolSection identificationModule nctId: NCT06304467, orgStudyIdInfo id: IRB#23-001133, briefTitle: CM for Patients With ALD After Liver Transplant, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-09-01, completionDateStruct date: 2026-03-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Arpan A. Patel, MD, class: OTHER, descriptionModule briefSummary: 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. 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., conditionsModule conditions: Alcohol Use Disorder, conditions: Alcohol; Liver, conditions: Post Liver Transplant, conditions: Contingency Management, conditions: Alcohol Liver Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Contingency Management, outcomesModule primaryOutcomes measure: Number of Non-Drinking Days, secondaryOutcomes measure: Patient-Reported Outcomes Measurement Information System (PROMIS® 29+2 Profile v2.1 (PROPr)), secondaryOutcomes measure: Client Satisfaction Questionnaire-8., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False