Johns Hopkins University
This human laboratory study will collect preliminary safety and efficacy data from a sample of participants enrolled in a 4-week in-patient treatment program for alcohol use disorder.
Approximately 29 million persons in the United States aged 12 and older experienced a form of Alcohol Use Disorder (AUD) in 2023. Currently, only three pharmacotherapies are FDA-approved to treat AUD: acamprosate, naltrexone, and disulfiram. As monotherapies, these have shown moderate efficacy in reducing alcohol consumption and increasing abstinence. There is some evidence that therapeutic effects can be enhanced when combined with other medications. Recently, emerging preclinical evidence suggests that endogenous GLP-1 signaling plays a role in alcohol-mediated behaviors. Further, growing cl…
Inclusion Criteria: * Aged 21-65 years old * Enrolled at Ashley Addiction Treatment center at least one week prior to beginning study participation. * Meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for Alcohol Use Disorder * Willing to comply with the study protocol Exclusion Criteria: * Score 9 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) at randomization * Currently pregnant, breastfeeding * Unwilling to use contraceptives (e.g., condoms and/or hormonal birth control) * Meet crite…
Over-encapsulated non-active microcrystalline cellulose
Over-encapsulated Glucagon-Like Peptide-1 Agonist (GLP-1) oral tablets
Over-encapsulated Naltrexone (oral tablets)
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