Semaglutide Therapy for Alcohol Reduction - Tulsa

Launched by OKLAHOMA STATE UNIVERSITY CENTER FOR HEALTH SCIENCES · Jun 5, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Semaglutide Therapy for Alcohol Reduction - Tulsa" is investigating whether a medication called semaglutide can help reduce alcohol consumption in individuals who struggle with alcohol use disorder. This study is looking for adults aged 18 and older who have been diagnosed with alcohol use disorder, which means they show signs that their drinking may be harmful to their health. Participants will be divided into two groups: one will receive semaglutide, and the other will receive a placebo (an inactive substance) to compare the effects.

To be eligible for this trial, participants need to meet certain criteria. They should be able to give their consent to participate, have a history of drinking more than 7 drinks per week for women or 14 drinks per week for men, and have at least two symptoms of alcohol use disorder. Participants can expect regular visits during the trial, where their drinking habits and health will be monitored. It's important to note that those with certain health conditions, particularly related to diabetes or mental health, may not be eligible. This trial aims to provide valuable insights into the safety and effectiveness of semaglutide for helping individuals reduce their alcohol intake.

Gender

ALL

Eligibility criteria

• 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-5 Checklist for Alcohol Use Disorder, the Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))
• • 4. Self-reported drinking, according to alcohol TimeLine Follow-Back (TLFB), of \> 7 drinks per week for females or \> 14 drinks per week for males during the 28-day period prior to screening + at least four days with \> 3 drinks for females or \> 4 drinks 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 normal or corrected-to-normal (e.g., with the use of a hearing aid) hearing
• • 8. Female participants must be postmenopausal for at least one year, surgically sterile, or practicing a highly effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at each visit. Examples of birth control methods include (but are not limited to) oral contraceptives or contraceptive implants, barrier methods such as diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms, intrauterine devices, 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 lipase levels
• • 4. Present diagnosis of diabetes or blood hemoglobin A1c (HbA1c) ≥ 6.5 %
• • 5. Current use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones (TZD), dipeptidyl peptidase-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 to enrollment in the study.
• • 8. Current use of FDA-approved pharmacotherapy for AUD (acamprosate, disulfiram, naltrexone), or other medications that are used for AUD treatment including topiramate and bupropion. Due to the half-life of injectable naltrexone, we will exclude 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 Multiple Endocrine 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 any other GLP-1 analogue
• • 14. Known history of suicidal attempts (within the past 24 months) or active suicidal ideation
• • 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 ECG abnormalities)
• • 19. Physical and/or mental health conditions that are clinically unstable, as determined by the study clinicians, including (but not limited to) major depressive disorder or generalized anxiety disorder unstable within the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable within the past twelve months.
• • 20. Current stimulant or opioid use disorder.
• • 21. Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a possible subject