Alcohol Use DisorderPhase 2STAR-TNCT05891587
Semaglutide Therapy for Alcohol Reduction - Tulsa
A Phase 2 study testing Semaglutide in people with Alcohol Use Disorder, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2023to 1 Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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
- Known history of noise-induced hearing loss or tinnitus
- Only for subjects undergoing brain scan: contraindication(s) for brain fMRI
- Unstable cardiovascular conditions (e.g., arrhythmias, clinically significant ECG abnormalities)
- 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.
- Current stimulant or opioid use disorder.
- Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a possible subject
Trial locations and contacts
1 site in 1 country.
United States1 site
OSU Biomedical Imaging Center
Tulsa, Oklahoma, 74136
About this study
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled clinical trial assessing the efficacy and tolerability of semaglutide in individuals who meet criteria for alcohol use disorder. Participants will complete a remote phone screening and an on-site screening visit to determine study eligibility. Eligible participants will be randomized to receive weekly subcutaneous injections of either semaglutide or a placebo (1:1 ratio). Doses will be titrated according to the FDA-approved dosing schedule starting at a dose of 0.25 mg/week for four weeks, then 0.5 mg/week for four weeks, and finally the dose will be increased to 1.0 mg/week for four weeks, for a total of 12 weeks of treatment. Participants will be asked to complete experimental procedures at the baseline and endpoint visits (Week 1 and Week 12), which include functional magnetic resonance imaging (fMRI) experiments, functional near-infrared spectroscopy (fNIRS) experiments, and virtual reality experiments. Participants will also complete questionnaires, biospecimen collections, and computer-based behavioral therapy modules at various study timepoints. Participants will periodically meet with a study physician and will be monitored for any adverse events. A remote follow-up assessment will take place 9 weeks after the participant's last dosing visit.
- Conditions
- Alcohol Use Disorder
- Being tested
- Semaglutide, Placebo
- Keywords
- Alcohol, Ozempic, Wegovy, Semaglutide, Addiction, Substance Use, Alcohol drinking, Alcohol-Related Disorders
- Medical subject headings
- Alcoholism, Behavior, Addictive, Substance-Related Disorders, Alcohol Drinking, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Semaglutide pen injector
PlaceboDrug
Saline solution
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive subcutaneous injections of semaglutide in escalating doses (.25mg to 1.0mg) over the course of 12 weeks. Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Participants will receive subcutaneous injections of a placebo saline solution over the course of 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 1) to post-medication (Week 13)
Secondary outcomes (8)
Change in drinks per week.
The average number of standard alcohol-containing drinks consumed per week (DPW) measured over the 28 days preceding the study baseline visit, and the average daily consumption during at least the first 14 days at each dose, up to the first 28 days at each dose.
Measured: Baseline (Week 1) to post-medication (Week 13)
Change in heavy drinking days per week.
The average number of heavy drinking days per week measured over the 28 days preceding the study baseline visit, and the average number of heavy drinking days per week during at least the first 14 days at each dose, up to the first 28 days at each dose.
Measured: Baseline (Week 1) to post-medication (Week 13)
Safety and tolerability of semaglutide in individuals with alcohol use disorder (AUD)
Number and grade of adverse events in individuals with AUD who receive semaglutide or placebo
Measured: Baseline (Week 1) to post-medication (Week 13)
Reduction and/or changes in food choices in a virtual reality buffet-like laboratory
Difference in the macronutrient content selected in the virtual reality buffet
Measured: Baseline (Week 1) to post-medication (Week 13)
Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use
Difference in blood PEth levels
Measured: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity in response to alcohol cues during fMRI cue reactivity task
Group differences in fMRI blood oxygenation level dependent (BOLD) signal within reward neurocircuitry in response to alcohol and nonalcoholic beverage stimuli
Measured: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity during an fMRI interoceptive attention task
Group differences in fMRI blood oxygenation level dependent (BOLD) signal within interoceptive brain regions during an interoceptive attention task.
Measured: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity during an alcohol-related Go/No-Go fNIRS task
Difference in activity of inhibitory brain regions during an alcohol-related Go/No-Go fNIRS task.
Measured: Baseline (Week 1) to post-medication (Week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start7 Jul 2023
- Primary completion30 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, between-subject, double-blind, and placebo-controlled.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Drug Abuse
- Responsible party
- Sponsor
- Investigators
- William K Simmons, Ph.D., Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891587
- Sponsor's protocol ID
- 202208
- Acronym
- STAR-T
- Status last verified
- Dec 2025
- First submitted
- 4 May 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared with other investigators upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide Therapy for Alcohol Reduction - Tulsa
- ClinicalTrials.gov ID
- NCT05891587
- Acronym / sponsor ID
- STAR-T / 202208
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol, Ozempic, Wegovy, Semaglutide, Addiction, Substance Use, Alcohol drinking, Alcohol-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Drug Abuse
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled clinical trial assessing the efficacy and tolerability of semaglutide in individuals who meet criteria for alcohol use disorder. Participants will complete a remote phone screening and an on-site screening visit to determine study eligibility. Eligible participants will be randomized to receive weekly subcutaneous injections of either semaglutide or a placebo (1:1 ratio). Doses will be titrated according to the FDA-approved dosing schedule starting at a dose of 0.25 mg/week for four weeks, then 0.5 mg/week for four weeks, and finally the dose will be increased to 1.0 mg/week for four weeks, for a total of 12 weeks of treatment. Participants will be asked to complete experimental procedures at the baseline and endpoint visits (Week 1 and Week 12), which include functional magnetic resonance imaging (fMRI) experiments, functional near-infrared spectroscopy (fNIRS) experiments, and virtual reality experiments. Participants will also complete questionnaires, biospecimen collections, and computer-based behavioral therapy modules at various study timepoints. Participants will periodically meet with a study physician and will be monitored for any adverse events. A remote follow-up assessment will take place 9 weeks after the participant's last dosing visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, between-subject, double-blind, and placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideParticipants will receive subcutaneous injections of semaglutide in escalating doses (.25mg to 1.0mg) over the course of 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive subcutaneous injections of a placebo saline solution over the course of 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideSemaglutide pen injector | Drug | Semaglutide |
| PlaceboSaline solution | Drug | Placebo |
Primary outcome
Change in alcohol drinks per drinking day.
Time frame: Baseline (Week 1) to post-medication (Week 13)
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.
8 secondary outcomes
Change in drinks per week.
Time frame: Baseline (Week 1) to post-medication (Week 13)
Change in heavy drinking days per week.
Time frame: Baseline (Week 1) to post-medication (Week 13)
Safety and tolerability of semaglutide in individuals with alcohol use disorder (AUD)
Time frame: Baseline (Week 1) to post-medication (Week 13)
Reduction and/or changes in food choices in a virtual reality buffet-like laboratory
Time frame: Baseline (Week 1) to post-medication (Week 13)
Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use
Time frame: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity in response to alcohol cues during fMRI cue reactivity task
Time frame: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity during an fMRI interoceptive attention task
Time frame: Baseline (Week 1) to post-medication (Week 13)
Changes in brain activity during an alcohol-related Go/No-Go fNIRS task
Time frame: Baseline (Week 1) to post-medication (Week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Link to online eligibility screenerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD will be shared with other investigators upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William K Simmons, Ph.D. principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Alcohol Use Disorder, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol drinks per drinking day. (time frame: Baseline (Week 1) to post-medication (Week 13)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.