Alcohol Use DisorderTHRIVENCT07397598
Peer Support for Liver Transplant Recipients With History of ALD
A study testing Peer Support in people with Alcohol Use Disorder and Alcohol Related Liver Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Related Liver Disease, Liver Transplant Recipient
- What is being tested?
- Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Jun 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speakers
- Received a liver transplant for alcohol-associated liver disease
- Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry
Who cannot join
- Liver transplant recipients without a history of alcohol-associated liver disease
- Inability to provide informed consent
- Active participation in a separate intervention trial for alcohol use disorder
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, 1 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Po-Hung Chen, MD, PhD, 410-550-1793, pchen37@jhmi.edu
Mary E. McCaul, PhD, 410-955-9526, mmccaul1@jhmi.edu
About this study
Official title: Peer Support to Enhance Care for Liver Transplant Recipients Who Had Alcohol-Associated Liver Disease
Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions:
- Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall?
- Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?
Read the detailed description
In the United States, ALD is the most common indication for LT. Resuming alcohol use is a major concern for all LT recipients with a history of ALD, with estimates ranging from 16% to 49% and increasing with more time since LT. Although most LT programs have required pre-LT alcohol treatment, post-LT services have been far more heterogeneous, despite the potentially severe consequences of alcohol relapse during this period. The present study proposes implementing and evaluating a care model for LT recipients with a history of ALD after the first post-LT year. The investigators will conduct a single-arm clinical trial to integrate PSS into routine medical care starting in years 2 through 4 following LT. The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will first receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. The PSS will then meet with study participants at regular intervals between standard clinic visits. The investigators will follow participants working with PSS for 1 year and compare the participants with a historical control group of transplant recipients without PSS to determine whether the intervention improves outcomes. Key endpoints will include alcohol use (by self-report and biomarker), retention in post-transplant medical care, and overall survival.
- Being tested
- Peer Support
- Keywords
- Alcohol use disorder, Alcohol Related Liver Disease, Liver transplant recipient, Peer support specialist
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer SupportBehavioural
The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality.
Participants will meet regularly with a PSS between standard clinic visits throughout a one-year study period. The PSS will deliver brief counseling interventions at each session. Study investigators will meet with the PSS at scheduled intervals to review progress. Study investigators will also review up to 20% of the audio recordings of sessions between PSS and study participants to assess fidelity to the intervention protocol.
| Study group | Role | What they receive |
|---|---|---|
| Peer Support Specialist (PSS) | Experimental | Not described Receives: Behavioral: Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption
Any use or excessive use (i.e., >7/>14 drinks per week for women/men) by biomarker or self-report
Measured: Up to 1 year
Secondary outcomes (2)
Liver Transplant Medical Treatment Engagement
Proportion of kept/scheduled LT follow-up medical appointments
Measured: Up to 1 year
Overall Post-Liver Transplant Survival
All-cause mortality
Measured: Up to 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 Feb 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Po-Hung Chen, MD, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397598
- Sponsor's protocol ID
- IRB00466249
- Other IDs
- P50AA027054
- Acronym
- THRIVE
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient reported outcomes and phosphatidylethanol biomarker results