An interventional study of Peer Support in Alcohol Use Disorder, Alcohol Related Liver Disease and Liver Transplant Recipient, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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:
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.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 95 is close to the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Peer Support
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.
Alcohol Consumption
Any use or excessive use (i.e., \>7/\>14 drinks per week for women/men) by biomarker or self-report
Time frame: Up to 1 year
Liver Transplant Medical Treatment Engagement
Proportion of kept/scheduled LT follow-up medical appointments
Time frame: Up to 1 year
Overall Post-Liver Transplant Survival
All-cause mortality
Time frame: Up to 1 year
Plan to share: Yes — Patient reported outcomes and phosphatidylethanol biomarker results
Time frame: Data will be shared with the general research community at the time of an associated publication, or the end of the award/grant period, whichever comes first. Data will be shared indefinitely.
Access criteria: Summaries of NIAAA Data Archive (NIAAADA) data are publicly available to anyone through the NDA Query Tool without an account. Access to individual participant data and supporting documentation is limited to qualified researchers who create an NDA account and submit a Data Access Request (DAR), including completion of the NDA Data Use Certification (DUC). Requests are reviewed by a NIAAA committee to ensure responsible data use. Individual-level data are accessed through the NDA Query Tool once approval is granted.
Data sharing details ↗ · www.niaaa.nih.gov
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2029, 32 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 32 months is close to that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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