Semaglutide Therapy for Alcohol Reduction - Tulsa

Inclusion Criteria:

1. Ability to provide informed consent before any trial-related activities

2. Male or female individuals who are at least 18 years old

3. Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., DSM-5Checklist for Alcohol Use Disorder, the Mini-International NeuropsychiatricInterview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))

4. Self-reported drinking, according to alcohol TimeLine Follow-Back (TLFB), of > 7drinks per week for females or > 14 drinks per week for males during the 28-dayperiod prior to screening + at least four days with > 3 drinks for females or > 4drinks for males during the 28-day period prior to screening.

5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar)score is ≤ 10

6. Able to speak, read, write, and understand English

7. Normal or corrected-to-normal (e.g., wearing glasses or contacts) vision and normalor corrected-to-normal (e.g., with the use of a hearing aid) hearing

8. Female participants must be postmenopausal for at least one year, surgicallysterile, or practicing a highly effective method of birth control before entry andthroughout the study and must have a negative urine pregnancy test at each visit.Examples of birth control methods include (but are not limited to) oralcontraceptives or contraceptive implants, barrier methods such as diaphragms withcontraceptive jelly, cervical caps with contraceptive jelly, condoms, intrauterinedevices, a partner with a vasectomy, or abstinence from intercourse.

Exclusion Criteria:

1. BMI < 25 kg/m2 or BMI ≥ 50 kg/m2

2. Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)

3. Most recent blood tests: creatinine ≥ 2 mg/dL, eGFR ≤ 60 mL/min/1.73 m2,triglycerides > 500 mg/dl, ALP > 4x the upper normal limit, abnormal blood lipaselevels

4. Present diagnosis of diabetes or blood hemoglobin A1c (HbA1c) ≥ 6.5 %

5. Current use of the following medications with glucose lowering properties: GLP-1analogues, sulfonylurea, insulin, metformin, thiazolidinediones (TZD), dipeptidylpeptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors

6. Current or prior use of semaglutide (Ozempic or Wegovy) or tirzepatide (Mounjaro).

7. Use of weight-lowering/anti-obesity medications within the past 90 days prior toenrollment in the study.

8. Current use of FDA-approved pharmacotherapy for AUD (acamprosate, disulfiram,naltrexone), or other medications that are used for AUD treatment includingtopiramate and bupropion. Due to the half-life of injectable naltrexone, we willexclude participants who have taken vivitrol in the past 30 days.

9. Current use of medications with known interactions with semaglutide

10. Personal or family history of medullary thyroid carcinoma (MTC) or MultipleEndocrine Neoplasia syndrome type 2 (MEN 2)

11. Known history of alcoholic ketoacidosis, pancreatitis (either acute or chronic),pancreatic carcinoma, gallbladder disease, jaundice, Mallory-Weiss syndrome (esophageal tears secondary to vomiting), esophageal varices, cirrhosis

12. Known history of gastric bypass surgery

13. Known or suspected allergy to semaglutide, any of the product components, or anyother GLP-1 analogue

14. Known history of suicidal attempts (within the past 24 months) or active suicidalideation

15. Known history of vestibular disorders or clinically significant motion sickness

16. Known history of noise-induced hearing loss or tinnitus

17. Only for subjects undergoing brain scan: contraindication(s) for brain fMRI

18. Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECGabnormalities)

19. Physical and/or mental health conditions that are clinically unstable, as determinedby the study clinicians, including (but not limited to) major depressive disorder orgeneralized anxiety disorder unstable within the past three months or otherpsychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable within thepast twelve months.

20. Current stimulant or opioid use disorder.

21. Any other reason or clinical condition that the Investigators judge would interferewith study participation and/or be unsafe for a possible subject