Liver Transplant RecipientILTARPNCT07214259
Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
A study testing Online Sober Active Community and Recovery coach in people with Liver Transplant Recipient and Alcohol Use Disorders (AUD), run by Leigh Anne Dageforde at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Liver Transplant Recipient, Alcohol Use Disorders (AUD)
- What is being tested?
- Online Sober Active Community and Recovery coach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2027to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Development and Testing of an Integrated Care Coordination 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
Read more
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
Read the 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.
- Being tested
- Online Sober Active Community, Recovery coach
- Keywords
- liver transplant, alcohol use disorder, alcohol associated liver disease, recovery coach, sober active community
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Sober Active CommunityBehavioural
Participants will have access to an online sober active community that they can use to augment their recovery process.
Recovery coachBehavioural
Participants will work with a recovery coach including having weekly phone calls with that recovery coach.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online Sober Active Community; Behavioral: Recovery coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
Secondary outcomes (6)
Alcohol use clinically based on lab
the lab test phosphatidylethanol will be used to assess alcohol use
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
Alcohol use based on self report
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.
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
Alcohol cravings based on self report
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.
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
engagement in recovery resources
Participants will complete a survey on their engagement in recovery resources.
Measured: 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
The number of missed lab appointments and transplant clinic no-show rates will be calculated from the medical record.
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
medication adherence
Tacrolimus levels will be obtained from the medical record to calculate tacrolimus intrapatient variability.
Measured: Baseline, month 3, month 6, month 9, and study end (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Mar 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant RecipientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leigh Anne Dageforde
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Leigh Anne Dageforde, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214259
- Sponsor's protocol ID
- 251447
- Other IDs
- K23AA031068
- Acronym
- ILTARP
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All PID that underlie results in a publication can be shared with proper requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of an Integrated Care Coordination Intervention for Alcohol Use Disorder Recovery After Liver Transplantation
- ClinicalTrials.gov ID
- NCT07214259
- Acronym / sponsor ID
- ILTARP / 251447
- Keywords
- liver transplant, alcohol use disorder, alcohol associated liver disease, recovery coach, sober active community
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Leigh Anne DagefordeUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Recovery coachThe 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. |
| Intervention | Experimental | Behavioral: Online Sober Active Community, Behavioral: Recovery coachThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Sober Active CommunityParticipants will have access to an online sober active community that they can use to augment their recovery process. | Behavioural | Intervention |
| Recovery coachParticipants will work with a recovery coach including having weekly phone calls with that recovery coach. | Behavioural | Control, Intervention |
Primary outcome
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.
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.
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.
6 secondary outcomes
Alcohol use clinically based on lab
Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)
Alcohol use based on self report
Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)
Alcohol cravings based on self report
Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)
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.
clinic and lab adherence
Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)
medication adherence
Time frame: Baseline, month 3, month 6, month 9, and study end (1 year)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. All PID that underlie results in a publication can be shared with proper requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Sober Active Community and Recovery coach in people with Liver Transplant Recipient and Alcohol Use Disorders (AUD), run by Leigh Anne Dageforde at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leigh Anne Leigh Anne Dageforde, MD, MPH (615-322-5000, la.dageforde@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.