Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

Not Applicable

Not yet recruiting

• Conditions: Liver Transplant Recipient; Alcohol Use Disorders (AUD)

• Registration Number: NCT07214259
• Lead Sponsor: Leigh Anne Dageforde

Brief Summary

The goal of this clinical trial is to learn if it is feasible and acceptable to use a recovery coach and an online sober active community to help with alcohol use disorder after liver transplant. The main questions it aims to answer are:

* Is using a recovery coach after liver transplant to help with alcohol use recovery feasible and acceptable?

* Is using an online sober active community after liver transplant to help with alcohol use recovery feasible and acceptable? Researchers will compare standard of care including a recovery coach alone to a recovery coach plus to assist with recovery from alcohol use recovery after liver transplant

Participants will:

* Work with a recovery coach including a weekly phone call

* Visit the clinic once every 3 months for a checkup and to complete surveys

* If randomized to the intervention arm, download an online application with access to a digital sober active community

Detailed Description

Rates of alcohol use disorder and alcohol associated liver disease requiring liver transplantation continue to rapidly rise. Return to alcohol use after liver transplant is associated with increased rates of liver transplant failure and mortality, but there is no evidence-based integrated intervention to address alcohol use disorder in liver transplant recipients. The goal of this pilot feasibility randomized control trial is to address a critical gap in knowledge and care for liver transplant recipients with concurrent alcohol use disorder by developing and pilot testing an integrated liver transplant and alcohol recovery program (ILTARP) consisting of a recovery coach supporting post-transplant alcohol relapse prevention, outreach, and care coordination with the added intervention of access to an active sober community. The investigators will conduct a pilot feasibility study of the newly developed ILTARP intervention testing feasibility, acceptability, and potential effectiveness of ILTARP in the liver transplant clinical setting.

Study Timeline

• Study First Submitted: 2025-09-24
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-03
• Last Update Submitted: 2025-10-03
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2026-07-01
• Primary Completion: 2027-12
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory)	Baseline, month 3, month 6, month 9, and study end (1 year)	Measured by the Acceptability of Intervention Measure (AIM) survey. The scale ranges from 3 to 15 with a high score indicating greater acceptability.
Feasibility of ILTARP (the degree to which ILTARP can be carried out successfully)	Baseline, month 3, month 6, month 9, and study end (1 year)	Measured by the Feasibility of Intervention Measure (FIM) survey. The scale ranges from 3 to 15 with a high score indicating greater feasibility.
Appropriateness of ILTARP (ILTARP suitability and relevance)	Baseline, month 3, month 6, month 9, and study end (1 year)	Measured by the Intervention Appropriateness Measure (IAM).The scale ranges from 3 to 15 with a high score indicating greater appropriateness.

Secondary Outcome Measures

Name	Time	Method
Alcohol use clinically based on lab	Baseline, month 3, month 6, month 9, and study end (1 year)	the lab test phosphatidylethanol will be used to assess alcohol use
Alcohol use based on self report	Baseline, month 3, month 6, month 9, and study end (1 year)	Alcohol use will be self reported using the Alcohol Use Disorders Identification (AUDIT-C) scale. The scale ranges from 0 to 12 with 0 being the lowest amount of alcohol and 12 being the most amount of alcohol.
Alcohol cravings based on self report	Baseline, month 3, month 6, month 9, and study end (1 year)	Alcohol cravings will be self reported using the Penn Alcohol Craving Scale (PACS). Scale score ranges from 0-30 with 0 being the least amount of cravings and 30 the most.
engagement in recovery resources	Baseline, month 3, month 6, month 9, and study end (1 year)	Participants will complete a survey on their engagement in recovery resources.
clinic and lab adherence	Baseline, month 3, month 6, month 9, and study end (1 year)	The number of missed lab appointments and transplant clinic no-show rates will be calculated from the medical record.
medication adherence	Baseline, month 3, month 6, month 9, and study end (1 year)	Tacrolimus levels will be obtained from the medical record to calculate tacrolimus intrapatient variability.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States