Semaglutide Therapy for Alcohol Reduction (STAR) Study
This study, called STAR, is looking into whether Semaglutide, a medication given as a weekly shot, can help reduce alcohol drinking in people with Alcohol Use Disorder (AUD). Participants will also receive a computer-based behavioral therapy called "Take Control." The main goal is to see if Semaglutide, compared to a placebo (an inactive substance), lowers the number of standard alcoholic drinks consumed per week. Adults aged 18 and older with an AUD diagnosis may be able to join. The study aims to enroll 63 participants, but its current status is unclear. Success for this study means showing that Semaglutide can safely and effectively reduce alcohol consumption.
- Study design
- This is an interventional study planning to enroll 63 participants. It will compare Semaglutide to a placebo.
- What's involved
- You would visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit could last between 2 and 6 hours.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures alcohol consumption from baseline to the end of the study.
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NCT06015893
Semaglutide Therapy for Alcohol Reduction (STAR)
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Institute on Drug Abuse (NIDA)Government-funded
~63 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Take ControlSemaglutide
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine whether semaglutide, compared to placebo, reduces alcohol drinking.
Measured over Difference in number of standard alcohol-containing drinks consumed / week (Drinks Per Week, DPW) from baseline to end of the study.
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Lorenzo Leggio, M.D. · PRINCIPAL_INVESTIGATOR · National Institute on Drug Abuse (NIDA)
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
At least 18 years old
Alcohol Use Disorder (minimum 2 symptoms on a validated diagnostic tool, e.g., 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 plus 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 \< 10
Able to speak, read, write, and understand English as demonstrated by ability to understand and sign the NIDA screening protocol consent
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
Exclusion
BMI \< 23 kg/m\^2 or BMI \>= 50 kg/m\^2
Evidence of malnutrition as determined by the Nutrition Risk Screening 2002 (NRS-2002)
Most recent blood tests: creatinine \>= 2 mg/dL, eGFR \<45 mL/min/1.73 m\^2, triglycerides \> 500 mg/dl, ALP \> 4x the upper limit of normal, clinically abnormal lipase levels per study clinician
Present diagnosis of diabetes mellitus or blood hemoglobin A1c (HbA1c) \>= 6.5 %
Current (within the past 30 days) use of the following medications with glucose lowering properties: GLP-1 analogues, sulfonylurea, insulin, metformin, thiazolidinediones, dipeptidyl peptidase-4 (DPP-IV) inhibitors, sodium-glucose cotransporter-2 (SGLT-2) inhibitors
Current or prior use of semaglutide or tirzepatide
Current (within the past 30 days) use of weight-lowering medications
Current (within the past 30 days) use of FDA-approved pharmacotherapy for AUD (oral or intramuscular naltrexone, acamprosate, disulfiram)
Current (within the past 30 days) use of medications with known interaction with semaglutide
Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Known ongoing history of alcohol ketoacidosis, gastroparesis, 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 history of prior hypersensitivity reaction 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 clinically significant vestibular disorders or motion sickness
Known history of clinically significant noise-induced hearing loss or tinnitus
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 during the past three months or other psychiatric conditions (e.g., schizophrenia, bipolar disorder) unstable during the past twelve months prior to screening.
Female who is pregnant, breast-feeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant
What this trial measures
- Determine whether semaglutide, compared to placebo, reduces alcohol drinking.Difference in number of standard alcohol-containing drinks consumed / week (Drinks Per Week, DPW) from baseline to end of the study.
Recording the difference of alcohol consumption between baseline and end of the study is crucial to understand whether drinking amount/patterns change throughout the study, potentially due to the use of semaglutide.