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