Investigating Tirzepatide Treatment to Reduce Alcohol Use in Adults with Schizophrenia and Alcohol Use Disorder

What this Trial Is About

Researchers are investigating the potential of tirzepatide, a drug that acts on Glucose-dependent Insulinotropic Polypeptide and GLP-1 receptors, to reduce alcohol consumption in people diagnosed with both schizophrenia and alcohol use disorder. This study is a randomized, double-blinded, placebo-controlled trial aiming to understand if tirzepatide can lower the number of heavy drinking days and reduce brain activity related to alcohol cues. Functional magnetic resonance imaging fMRI brain scans will be used to explore the neurobiological effects of the treatment, which has not been previously studied in this population. The trial includes 108 participants who will receive weekly injections of either tirzepatide, titrated up to a maximum dose of 15 mg, or a placebo saline. The treatment period lasts 26 weeks with the main assessment at 16 weeks. All participants will also receive six sessions of supportive therapy during the study. An unblinded staff member will administer the injections while participants are blindfolded. A subgroup of 50 participants will undergo fMRI scans at the beginning and after 16 weeks of treatment. Blood tests and other safety assessments will be conducted at multiple points during the study. Participants will be evaluated at weeks 0, 4, 8, 12, 16, 20, 26, and 40, with a follow-up 14 weeks after the last treatment. Outcomes measured include changes in heavy drinking days, total alcohol consumption, days without drinking, alcohol craving scales, mental health assessments, and various biomarkers. Safety monitoring includes blood tests, liver and kidney function, and physical health checks. The study will conclude after all follow-ups, providing a comprehensive overview of tirzepatides effects on alcohol use and brain function in this group.

Effects of Tirzepatide on Alcohol Intake in Patients Diagnosed With Schizophrenia and Alcohol Use Disorder