Semaglutide for Alcohol Use Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Alcohol Use Disorder, Cigarette Smoking
In brief
This is an early-Phase II human laboratory trial using a randomized, placebo-controlled, dose-ranging design to investigate the effects of semaglutide, a GLP-1 receptor agonist, on alcohol-related outcomes in adults with alcohol use disorder (AUD).
Key facts
- Study ID
- NCT05520775
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 48
- Starts
- 2022-09-02
- Expected to finish
- 2024-04-19
- Last updated by the study team
- 2025-04-02
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 21-65
- Meeting DSM-5 criteria for current (past year) alcohol use disorder (with 2-7 symptoms endorsed) and National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for current at-risk drinking (i.e., >7/14 drinks in one week for women/men, with at least two episodes of 4+/5+ drinks in the past 30 days)
- Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring
- Willingness to complete laboratory sessions involving alcohol administration
- Ability to communicate and read in English
You may not qualify if…
- Reporting past 30-day use of illicit drugs other than cannabis at baseline, or having a positive toxicology screen for illicit drugs other than cannabis at baseline
- Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
- Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
- Past 30-day use of: Sincalide, Sulfonylureas, insulin and insulin products or other medications that may interact with semaglutide;, or weight control medications
- Prior use of semaglutide or other GLP-1 agonists
- Known or suspected hypersensitivity to study medication or related products
- Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
- History of suicide attempt, or recent (past 30 day) suicidal ideation, or psychiatric hospitalization in the last 6 months
- Current significant medical or neurological illness (based on self-report or medical record) including severe hepatic impairment or cirrhosis, impaired renal function (eGFR <50ml/min), acute or chronic pancreatitis, gastroparesis, gallbladder disease or cholelithiasis, other severe gastrointestinal disease, heart failure, coronary artery disease, stroke, seizure disorder, or other medical condition that poses a risk for the medication or alcohol administration components of the study (as determined by the MD)
- A personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B
- Calcitonin greater than or equal to 50 ng/L
- Uncontrolled thyroid disease at screening
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- History of Type 1 or Type 2 diabetes, or HbA1c >6.5% measured at screening
- History of diabetic retinopathy, proliferative retinopathy, or maculopathy
- History of diabetic ketoacidosis
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
- Currently nursing, pregnant, anticipating pregnancy in the next 6 months, or not using a highly effective contraceptive method as judged by the MD, and defined as:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- intrauterine device
- intrauterine hormone-releasing system
- bilateral tubal occlusion
- vasectomized partner
- sexual abstinence
Where it is running
- UNC-Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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