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Not Yet Recruiting NCT07249554

Combination Therapy for Alcohol Use Disorder

Conditions: Alcohol Use Disorder

Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 45
Sponsor: Johns Hopkins University

Location: Ashley Addiction Treatment Havre de Grace Maryland

Summary

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.

Eligibility Criteria

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 criteria for another substance use disorder other than AUD, Tobacco Use Disorder, or Caffeine use disorder * History of pancreatitis * History or current diagnosis of gallbladder disease, hepatic disease, renal disease, hyperparathyroidism, or any physical health condition that would be contraindicated with GLP-1 agonists or naltrexone. * Unmanaged diabetes diagnosis or history or current diagnosis of diabetic retinopathy * Levels of amylase, lipase, aspartate aminotransferase (AST), and/or alanine transferase (ALT) greater than 2x upper limit of normal * Personal or family history of medullary thyroid carcinoma given FDA box warning for semaglutide * Diagnosis of cancer within past 5 years * History of multiple endocrine neoplasia syndrome type 2 (MEN2) * Currently taking any medications contraindicated with GLP-1 agonists and/or naltrexone. * BMI \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07249554). StuddyBuddy aggregates publicly available trial information.