COMPLETED

Semaglutide Therapy for Alcohol Reduction - Tulsa

Conditions

Alcohol Use Disorder Alcohol Ozempic Wegovy Semaglutide Addiction Substance Use Alcohol drinking Alcohol-Related Disorders

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research study is to determine if semaglutide, when compared to placebo, is safe and may reduce alcohol drinking in individuals who endorse symptoms consistent with alcohol use disorder.

Official Title

Semaglutide Therapy for Alcohol Reduction - Tulsa

Quick Facts

Study Start:2023-07-07

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05891587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

William K Simmons, Ph.D.

PRINCIPAL_INVESTIGATOR

Oklahoma State University Center for Health Sciences

Study Locations (Sites)

OSU Biomedical Imaging Center

Tulsa, Oklahoma, 74136

United States

Collaborators and Investigators

Sponsor: Oklahoma State University Center for Health Sciences

William K Simmons, Ph.D., PRINCIPAL_INVESTIGATOR, Oklahoma State University Center for Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2023-07-07

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

Alcohol
Ozempic
Wegovy
Semaglutide
Addiction
Substance Use
Alcohol drinking
Alcohol-Related Disorders

Additional Relevant MeSH Terms

Alcohol Use Disorder