Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

NCT07214259 | Not Yet Recruiting DMC

• 2 other identifiers: 251447K23AA031068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Transplant Recipient; Alcohol Use Disorders (AUD)

Keywords

liver transplant; alcohol use disorder; alcohol associated liver disease; recovery coach; sober active community

Outcome Measures

Primary Outcomes (3)

• Acceptability of ILTARP (The perception that ILTARP is palatable, agreeable, or satisfactory)

  Measured by the Acceptability of Intervention Measure (AIM) survey. The scale ranges from 3 to 15 with a high score indicating greater acceptability.

  Baseline, month 3, month 6, month 9, and study end (1 year)

• Feasibility of ILTARP (the degree to which ILTARP can be carried out successfully)

  Measured by the Feasibility of Intervention Measure (FIM) survey. The scale ranges from 3 to 15 with a high score indicating greater feasibility.

  Baseline, month 3, month 6, month 9, and study end (1 year)

• Appropriateness of ILTARP (ILTARP suitability and relevance)

  Measured by the Intervention Appropriateness Measure (IAM).The scale ranges from 3 to 15 with a high score indicating greater appropriateness.

  Baseline, month 3, month 6, month 9, and study end (1 year)

Secondary Outcomes (6)

• Alcohol use clinically based on lab

  Baseline, month 3, month 6, month 9, and study end (1 year)

• Alcohol use based on self report

  Baseline, month 3, month 6, month 9, and study end (1 year)

• Alcohol cravings based on self report

  Baseline, month 3, month 6, month 9, and study end (1 year)

• engagement in recovery resources

  Baseline, month 3, month 6, month 9, and study end (1 year). The participants will select what resources they have used and how often they have been used. This is not a summarized scale therefore there is not a better or worse outcome.

• clinic and lab adherence

  Baseline, month 3, month 6, month 9, and study end (1 year)

Study Arms (2)

Control

ACTIVE COMPARATOR

The participants in the control arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Behavioral: Recovery coach

Intervention

EXPERIMENTAL

The participants in the intervention arm will work with a recovery coach and have weekly phone calls with the recovery coach. They will also have access to an online sober active community that they can use to augment their recovery process. They will visit the clinic every 3 months for an in-person visit and to complete survey measures related to the study.

Behavioral: Online Sober Active Community; Behavioral: Recovery coach

Interventions

Online Sober Active Community BEHAVIORAL

Participants will have access to an online sober active community that they can use to augment their recovery process.

Intervention

Recovery coach BEHAVIORAL

Participants will work with a recovery coach including having weekly phone calls with that recovery coach.

Control; Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 21 years old
• Recipient of liver transplant less than or equal to 5 years ago
• History of alcohol use disorder
• Able to understand the purpose of the study and willing to participate and sign informed consent
• Has a smart phone to use for contact with recovery coach and the digital sober active community without additional personal cost
• Willing to participate in online digital community

You may not qualify if:

• Liver transplant recipient for reason other than alcohol associated liver disease
• Liver transplant greater than 5 years ago
• No mechanism for regular phone contact
• No ability to utilize an application for a digital sober active community
• Any condition that in the opinion of the PI introduces undue risk by participating in this study
• less than 21 years of age
• no history of alcohol use disorder
• Any condition that in the opinion of the PI introduces undue risk by participating in this study

Sponsors & Collaborators

• Leigh Anne Dageforde: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Leigh Anne Leigh Anne Dageforde, MD, MPH

CONTACT

615-322-5000; la.dageforde@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 9, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months and ending 2 years after the publication of results
• Access Criteria: This de-identified data will be available through the NIH mandatory data share through the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAA-DA). Requests for data sharing will be directed to the NIAAA-DA as the primary mechanism to obtain data. If unable to be obtained through the NIAAA-DA, a written proposal maybe submitted with planned analyses and use of the data. Each proposal will be reviewed. Only completely de-identified data will be shared. The recipient of the data must have institutional review board approval. There must be an approved and signed data use agreement.

Locations

US (1)