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NCT Number: NCT07214259

Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

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

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Key information

Conditions

Liver Transplant Recipient Alcohol Use Disorders (AUD) Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Enrollment:

  • 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

Exclusion criteria

for Enrollment

  • 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

Treatment and study plan

Online Sober Active Community

Behavioral

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

Recovery coach

Behavioral

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Appropriateness of ILTARP (ILTARP suitability and relevance)

    Time frame: 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 outcomes

  1. Alcohol use clinically based on lab

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

    the lab test phosphatidylethanol will be used to assess alcohol use

  2. Alcohol use based on self report

    Time frame: 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.

  3. Alcohol cravings based on self report

    Time frame: 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.

  4. engagement in recovery resources

    Time frame: 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.

    Participants will complete a survey on their engagement in recovery resources.

  5. clinic and lab adherence

    Time frame: 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.

  6. medication adherence

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Leigh Anne Leigh Anne Dageforde, MD, MPH

CONTACT

[email protected]

615-322-5000

Sponsors and collaborators

Lead sponsor

Leigh Anne Dageforde

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Development and Testing of an Integrated Care Coordination Intervention for Alcohol Use Disorder Recovery After Liver Transplantation

Acronym: ILTARP

Important dates

Study start
2027
Primary completion
2027
Study completion
2028
First posted
Oct 9, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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