ReviewNature reviews. Gastroenterology & hepatology2024
Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement.
Registry-linked trialAbstract readReviewConsensus Statement
In one paragraph
Review in Nature reviews. Gastroenterology & hepatology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07465588 (Randomized Evaluation of Incentives FOR Clinical Effectiveness in Liver Recovery), which is not on this map. Cited by 36 papers, 3 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 3 pooled it
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Evaluation of Incentives FOR Clinical Effectiveness in Liver Recovery (REINFORCE Trial): A PEth-Based Contingency Management Pilot Randomized Controlled Trial for Alcohol Use Disorder in Patients With Alcohol-Associated Liver Disease
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Survivorship interventions after liver transplantation (LT): A systematic review of interventions targeting physical and psychosocial well-being after LT.Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society · 2026Pooled it
- Pooled it
- Treatment of alcohol use disorder in alcohol-associated liver disease: A meta-analysis.Hepatology communications · 2025Pooled it
- Naltrexone Is Superior to Placebo for Abstinence and Craving Reduction in Alcohol-Associated Cirrhosis: NAL-CI Trial.Liver international : official journal of the International Association for the Study of the Liver · 2026Trial
- Contingency management to promote treatment engagement in comorbid alcohol use disorder and alcohol-related liver disease: Findings from a pilot randomized controlled trial.Alcohol, clinical & experimental research · 2025Trial
- The convergent roles of metabolic dysfunction, alcohol, and iron in steatotic liver disease: a review.Bioscience reports · 2026Review
- Challenges, Potential Solutions in Recruiting and Retaining Participants for Alcohol Use Disorder Research: A Literature Review.Healthcare (Basel, Switzerland) · 2026Review
- [Considerations on clinical trial issues related to new drug development for metabolic and alcohol-associated liver disease and fatty liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026Review
- Clinical trial endpoints for metabolic dysfunction and alcohol associated steatotic liver disease.Hepatology international · 2026Review
- A Bayesian Optimal Adaptive Clinical Trial Design for Sequentially Integrated Therapies.Statistics in medicine · 2026Article
- Development and Optimization of an LC-MS/MS Method for Quantification of Phosphatidylethanol in Human Whole Blood.Journal of mass spectrometry : JMS · 2026Article
- Therapeutics for Alcohol-Associated Liver Disease.Annual review of pharmacology and toxicology · 2026Review
- Addressing Alcohol Use Disorder in Alcohol-Associated Liver Disease.Clinical and translational gastroenterology · 2026Review
- Natural history and development of a novel composite endpoint in patients with alcohol-associated hepatitis: Data from a prospective multicenter study.Hepatology (Baltimore, Md.) · 2026Observational
- Choroid plexus cyst burden is associated with glymphatic dysfunction and cognitive impairment in hepatic encephalopathy.Hepatology communications · 2026Article
- Substance abuse and inflammation: consequences beyond the brain.Trends in immunology · 2026Review
- Evaluation of the lipid accumulation product for MASLD risk stratification in type 2 diabetes: establishing sex-specific thresholds and clinical utility.Cardiovascular diabetology · 2026Article
- Special Population: A Global Perspective on Metabolic Dysfunction-Associated Alcohol-Related Liver Disease.Clinics in liver disease · 2026Review
- Novel biomarkers for alcohol-associated liver disease and their implications across clinical settings.Clinical and molecular hepatology · 2026Review
- Parallel regulation of goblet cell-associated antigen passages by reduced microbial sensing and mAChR4 signaling in Muc2 deficiency prevents ethanol-induced liver injury.Hepatology (Baltimore, Md.) · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
31 authors.
Brian P Lee *Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA.
Katie Witkiewitz *Center on Alcohol, Substance use and Addictions, University of New Mexico, Albuquerque, NM, USA.
Jessica Mellinger *Department of Internal Medicine, Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.
Frank A AnaniaDivision of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD, USA.
Ramon BatallerLiver Unit, Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.ORCID http://orcid.org/0000-0002-1119-7799
Thomas G CotterDivision of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Brenda CurtisTechnology and Translational Research Unit, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program, Baltimore, MD, USA.
Srinivasan DasarathyDepartment of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA.ORCID http://orcid.org/0000-0003-1774-0104
Kelly S DeMartiniDepartment of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Ivan DiamondAmygdala Neurosciences, Palo Alto, CA, USA.
Nancy DiazgranadosOffice of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.ORCID http://orcid.org/0000-0002-7415-8455
Andrea F DiMartiniDepartments of Psychiatry and Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
Daniel E FalkMedications Development Branch, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Anne C FernandezDepartment of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.
Margarita N GermanDivision of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.ORCID http://orcid.org/0000-0003-3337-6760
Patrick S KamathDivision of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.ORCID http://orcid.org/0000-0002-7888-1165
Kelley M KidwellDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.
Lorenzo LeggioClinical Psychoneuroendocrinology and Neuropsychopharmacology Section, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore, MD, USA.
Raye LittenDivision of Treatment and Recovery, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Alexandre LouvetService des maladies de l'appareil digestif, University Hospital of Lille, Lille, France.
Michael R LuceyDivision of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Mary E McCaulDepartment of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.
Arun J SanyalStravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.
Ashwani K SingalDepartment of Medicine, Division of Gastroenterology Hepatology and Nutrition, University of Louisville School of Medicine, Louisville, KY, USA.ORCID http://orcid.org/0000-0003-1207-3998
Norman L SussmanDURECT Corporation, Cupertino, CA, USA.
Norah A TerraultDivision of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA.
Mark R ThurszDivision of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.
Elizabeth C VernaDivision of Digestive and Liver Diseases, Columbia University, New York, NY, USA.
Svetlana RadaevaSvetlana Radaeva, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.
Laura E NagyDepartment of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. nagyL3@ccf.org.ORCID http://orcid.org/0000-0002-0580-2809
Mack C MitchellDepartment of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. mack.mitchell@utsouthwestern.edu.ORCID http://orcid.org/0000-0001-9018-7988
Funding
Translational Technologies CoreP50AA012870 · NIAAA · YALE UNIVERSITY · PI John H. Krystal · 2001 to 2026
$43.7MProject Two - Exercise Training Decreases Alcohol Drinking by an FGF21-Dependent MechanismP50AA024333 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy · 2016 to 2026
$19.6MClinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN)ZIADA000635 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI LEGGIO, LORENZO · 2020 to 2025
$15.2MDigital Markers in Relapse and RecoveryZIADA000628 · NIDA · NATIONAL INSTITUTE ON DRUG ABUSE · PI CURTIS, BRENDA · 2019 to 2025
$10.0MAlcohol Research Consortium in HIV: Relapse Prevention ArmP01AA029544 · NIAAA · JOHNS HOPKINS UNIVERSITY · PI HUTTON, HEIDI · 2021 to 2025
$7.1MStress Effects on Alcohol Consumption: Age of onset and genes in heavy drinkersU01AA020890 · NIAAA · JOHNS HOPKINS UNIVERSITY · PI MCCAUL, MARY E, WAND, GARY S · 2012 to 2021
$3.6MCombined mGluR5 PET and fMRI imaging of Sex Differences during Cocaine WithdrawalR01DA042094 · NIDA · JOHNS HOPKINS UNIVERSITY · PI MCCAUL, MARY E, WAND, GARY S · 2017 to 2022
$3.5MIntegrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD)- Cleveland Clinic Clinical CenterU01AA026976 · NIAAA · CLEVELAND CLINIC LERNER COM-CWRU · PI Srinivasan Dasarathy, David Streem · 2018 to 2026
$3.2MPrecision Medicine and Recovery in a Telehealth Treatment Program for Alcohol Use DisorderR01AA022328 · NIAAA · UNIVERSITY OF NEW MEXICO · PI Katie A Witkiewitz · 2013 to 2026
$3.1MIntegrated therapies for alcohol use and ALD (ITAALD) Network – UTSW Clinical CenterU01AA026975 · NIAAA · UT SOUTHWESTERN MEDICAL CENTER · PI E SHERWOOD BROWN, Mack Clarence Mitchell · 2018 to 2026
$3.0MIntegrated Therapies for Alcohol use in Alcohol-associated Liver Disease (ITAALD) – Mayo ClinicU01AA026974 · NIAAA · MAYO CLINIC ROCHESTER · PI VICTOR M. KARPYAK, VIJAY H. SHAH · 2018 to 2026
$2.9MInvestigation of cerebellar involvement in AUDR01AA030368 · NIAAA · JOHNS HOPKINS UNIVERSITY · PI JOHN E DESMOND · 2022 to 2026
$2.9MNIAAA NIH HHS K23 AA029752NIAAA NIH HHS K23 AA031310NIAAA NIH HHS P01 AA029544NIAAA NIH HHS P50 AA012870NIAAA NIH HHS P50 AA024333NIAAA NIH HHS R01 AA022328NIAAA NIH HHS R01 AA030368NIAAA NIH HHS R01 AA030956NIAAA NIH HHS R01 AA030960NIAAA NIH HHS U01 AA020890NIAAA NIH HHS U01 AA021890NIAAA NIH HHS U01 AA026264NIAAA NIH HHS U01 AA026938NIAAA NIH HHS U01 AA026974NIAAA NIH HHS U01 AA026975NIAAA NIH HHS U01 AA026976NIDA NIH HHS R01 DA042094
Abstract
Most patients with alcohol-associated liver disease (ALD) engage in heavy drinking defined as 4 or more drinks per day (56 g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men. Although abstinence from alcohol after diagnosis of ALD improves life expectancy and reduces the risk of decompensation of liver disease, few studies have evaluated whether treatment of alcohol use disorders will reduce progression of liver disease and improve liver-related outcomes. In November 2021, the National Institute of Alcohol Abuse and Alcoholism commissioned a task force that included hepatologists, addiction medicine specialists, statisticians, clinical trialists and members of regulatory agencies to develop recommendations for the design and conduct of clinical trials to evaluate the effect of alcohol use, particularly treatment to reduce or eliminate alcohol use in patients with ALD. The task force conducted extensive reviews of relevant literature on alcohol use disorders and ALD. Findings were presented at one in-person meeting and discussed over the next 16 months to develop the final recommendations. As few clinical trials directly address this topic, the 28 recommendations approved by all members of the task force represent a consensus of expert opinions.
Indexed as
Alcohol DrinkingClinical Trials as TopicLiver Diseases, AlcoholicAlcoholismConsensusHumansResearch Design
Identifiers
What OpenQuestion holds
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Read underepoch 390
Registered trials
NCT07465588ClinicalTrials.gov
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.