A study testing whether a GLP-1 medicine from National Institute on Drug Abuse (NIDA), semaglutide, works for this condition.
- Who can join
- Adults 18 to 110, have addiction, BMI 23+.
- What you take
- semaglutide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 7.2 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Addiction. Also studied in: Alcohol Use Disorder.
Full scientific study title: Semaglutide Therapy for Alcohol Reduction (STAR).
Who can join
Adults 18 to 110, have addiction, BMI 23+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- 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
Key exclusion criteria
- 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
Where this study is enrolling
This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.
Maryland1 site
- National Institute on Drug AbuseBaltimore, Maryland
Timeline
Started enrolling: 2023-10-17. Expected completion: 2030-12-31. Last updated on ClinicalTrials.gov: 2026-07-02.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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