216
Participants
Start Date
October 31, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2029
IL-22
F-652 (IL-22) is a fusion protein of human IL-22 with IgG2 fragment, and has anti-inflammatory effects
Prednisone
Prednisone is an adrenal glucocorticoid with anti-inflammatory effects
Acamprosate
Acamprosate is a propane-1 sulfonic acid with anti-ethanol dependency effects
Prednisone placebo
Matching placebo
IL-22 (F-652) Placebo
Matching Placebo
Motivational Interviewing (MI)
MI is an evidence-based counseling style to overcome ambivalence to treatment in AUD patients
Motivational Enhancement Therapy (MET)
MET is an MI-based approach that includes 2-4 behavioral treatment sessions based on the Platform Treatment Manual
Usual Care
defined as a brief intervention with advice not to drink alcohol-containing beverages and referral to a 12-step program
University of Texas Southwestern Medical School, Dallas
Virginia Commonwealth University, Richmond
University of Louisville, Louisville
Cleveland Clinic, Cleveland
Indiana University, Indianapolis
Mayo Clinic, Rochester
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Samer Gawrieh
OTHER