Endurance exercise to see if it lowers alcohol use in adults with AUD and ALD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, unblinded study will assign 30 adults with AUD/ALD to either endurance exercise plus standard care or standard care alone for 12 weeks. The exercise group will perform thrice-weekly, remote-supervised cycling sessions of about 60 minutes each, with safety-adjusted intensity. The trial will measure changes in alcohol consumption and craving, as well as biomarkers such as FGF21, liver injury markers, and physical and metabolic endpoints, with exploratory analyses of molecular and microbiome data. Researchers aim to determine whether structured endurance exercise can improve liver and muscle outcomes and reduce alcohol-related behaviors, potentially via FGF21-related mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • Adults age 18 years or older, of either sex.

  * Clinical diagnosis of alcohol use disorder (AUD) / alcohol-related liver disease (ALD).
  * Meets NIAAA hazardous-drinking criteria: at least 7 drinks/week for women or 14 drinks/week for men for more than 6 months, with ongoing alcohol use within 2 months of evaluation.
  * MELD score less than 21.
  * Able to safely participate in exercise testing and endurance exercise.
  * Able to provide informed consent.
  * No concurrent renal, cardiac, pulmonary, cerebrovascular, or malignant illness that affects skeletal muscle mass; no diabetes mellitus; and no use of medications that affect skeletal muscle mass/protein turnover as described in the protocol, including anabolic steroids, high-dose corticosteroids, or anticoagulants.

Exclusion Criteria:

* • Pedal edema above the ankle or grade 2 pedal edema.

  * Liver transplant.
  * Active malignancy.
  * Gastrointestinal bleed within the previous 4 weeks.
  * Hepatic encephalopathy within the previous 6 months.
  * Grade 2 or greater active esophageal varices.
  * Active infection.
  * Large ascites by clinical and/or imaging criteria.
  * Advanced cardiac disease (NYHA class 3 or 4) or advanced pulmonary disease (GOLD class 3 or 4).
  * Use of medications affecting muscle protein turnover, including corticosteroids, or medications used to prevent clotting.
  * Prior orthopedic surgery or chronic joint pain that, in the opinion of the PI, may inhibit participation.
  * INR greater than 1.7 or platelet count less than 60,000/mL.
  * Unable to provide informed consent; judged likely to be unable to perform exercise or unlikely to complete the study in the opinion of the investigators.
  * End-stage kidney disease defined as eGFR less than 15 mL/min/1.73 m² or dialysis.
  * Considered unsafe for exercise in the opinion of the PI.
  * Failure to pass the exercise stress test.

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Srinivasan Dasarathy, MD — The Cleveland Clinic
• Study coordinator: Annette Bellar, PhD
• Email: bellara@ccf.org
• Phone: 216-445-6268

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Imaging Mitochondrial Complex-I and Brain Metabolism in Alcohol Use Disorder

  This study tests whether PET imaging with [18F]BCPP-EF and [18F]FDG can reveal differences in brain energy use between adults with alcohol use disorder and healthy controls, and whether these measures relate to relapse risk.

  Recruiting Early Phase 1 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07825818

• Do beverage cues drive craving in adults with AUD

  In adults with alcohol use disorder, this study tests whether different non-alcoholic beverage cues can trigger cravings differently when people see and smell them without drinking.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT07788716

• Semaglutide for Alcohol Use Disorder and Obesity: Testing 1.0 mg and 2.0 mg vs Placebo

  We’re testing two doses of semaglutide to see if they reduce alcohol craving and use in adults with alcohol use disorder and obesity compared with placebo.

  Recruiting at 2 sites Phase 1 Yale University · New Haven, Connecticut and 1 other locations · NCT07772960

• TRIS: a mobile app with breathalyzer to support sobriety in alcohol use disorder

  A smartphone app with a connected breathalyzer tests for abstinence and uses small financial incentives to encourage sobriety for adults with AUD in Brazil.

  Recruiting University of Sao Paulo General Hospital · São Paulo, São Paulo · NCT07735585

• Body-focused mindfulness added to inpatient alcohol use disorder treatment

  This trial tests whether a body-focused mindfulness program can help people with alcohol use disorder feel more connected to their bodies and reduce cravings while in inpatient care.

  Recruiting Medical University of Warsaw · Warsaw, Mazovian · NCT07706660

• Optimizing Smart Messaging for Alcohol Recovery

  A smartphone-based program tests whether tailored recovery messages can help people with alcohol use disorder stay engaged with support resources and improve health outcomes.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT07573540

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.