Semaglutide Therapy for Alcohol Reduction - Tulsa

NCT05891587 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 202208
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in alcohol drinks per drinking day.

  The average number of standard alcohol-containing drinks consumed per drinking day (DDD) measured over the 28 days preceding the study baseline visit, and the average DDD during at least the first 14 days at each dose, up to the first 28 days at each dose.

  Baseline (Week 1) to post-medication (Week 13)

Secondary Outcomes (8)

• Change in drinks per week.

  Baseline (Week 1) to post-medication (Week 13)

• Change in heavy drinking days per week.

  Baseline (Week 1) to post-medication (Week 13)

• Safety and tolerability of semaglutide in individuals with alcohol use disorder (AUD)

  Baseline (Week 1) to post-medication (Week 13)

• Reduction and/or changes in food choices in a virtual reality buffet-like laboratory

  Baseline (Week 1) to post-medication (Week 13)

• Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use

  Baseline (Week 1) to post-medication (Week 13)

Study Arms (2)

Semaglutide

EXPERIMENTAL

Participants will receive subcutaneous injections of semaglutide in escalating doses (.25mg to 1.0mg) over the course of 12 weeks.

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Participants will receive subcutaneous injections of a placebo saline solution over the course of 12 weeks.

Drug: Placebo

Interventions

Semaglutide DRUG

Semaglutide pen injector

Semaglutide

Placebo DRUG

Saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent before any trial-related activities
• Male or female individuals who are at least 18 years old
• 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))
• 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.
• Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score is ≤ 10
• Able to speak, read, write, and understand English
• 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
• 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.

You may not qualify if:

• BMI \< 25 kg/m2 or BMI ≥ 50 kg/m2
• Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
• 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
• Present diagnosis of diabetes or blood hemoglobin A1c (HbA1c) ≥ 6.5 %
• 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
• Current or prior use of semaglutide (Ozempic or Wegovy) or tirzepatide (Mounjaro).
• Use of weight-lowering/anti-obesity medications within the past 90 days prior to enrollment in the study.
• 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.
• Current use of medications with known interactions with semaglutide
• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• 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
• Known history of gastric bypass surgery
• Known or suspected allergy to semaglutide, any of the product components, or any other GLP-1 analogue
• Known history of suicidal attempts (within the past 24 months) or active suicidal ideation
• Known history of vestibular disorders or clinically significant motion sickness

Sponsors & Collaborators

• National Institute of Drug Abuse: collaborator
• Oklahoma State University Center for Health Sciences: lead

Study Sites (1)

OSU Biomedical Imaging Center

Tulsa, Oklahoma, 74136, United States

Location

Related Links

• Link to online eligibility screener

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive; Substance-Related Disorders; Alcohol Drinking; Alcohol-Related Disorders

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior; Drinking Behavior

Study Officials

• William K Simmons, Ph.D.

  Oklahoma State University Center for Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, between-subject, double-blind, and placebo-controlled.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: June 7, 2023
• Study Start: July 7, 2023
• Primary Completion: July 30, 2025
• Study Completion: October 1, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available following publication of study manuscripts and will be available indefinitely.
• Access Criteria: Reasonable request from qualified investigator.

Locations

US (1)