Clinical trial for Alcohol Use Disorder
Official title Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)
ClinicalTrials.gov ID: NCT07218354
What this study is testing
What is Semaglutide?
Semaglutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for alcohol use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial aims to test the effectiveness and safety of semaglutide, a GLP-1 receptor agonist, in treating moderate to severe alcohol use disorder (AUD) in Veterans. Participants who qualify will be randomly assigned to receive either semaglutide injections or placebo injections over a 24-week period, followed by a 4-week post-treatment safety assessment period.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Veteran
- World Health Organization's (WHO) risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)
- Current diagnosis of moderate or severe alcohol use disorder (AUD), i.e., meeting at least 4 of 11 DSM-5 AUD criteria, based on semi-structured...
- Able and willing to provide informed consent
- Has a desire to reduce their alcohol consumption
You likely can't join if
- Medical History (medical history form)
- Type 1 diabetes
- History of acute or chronic pancreatitis
- History of diabetic ketoacidosis
- History of proliferative diabetic retinopathy
- History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic...
See the full eligibility criteria
- Veteran
- World Health Organization's (WHO) risk drinking level of Very High or High in the 28 days prior to screening (based on screening TLFB)
- Current diagnosis of moderate or severe alcohol use disorder (AUD), i.e., meeting at least 4 of 11 DSM-5 AUD criteria, based on semi-structured diagnostic exam, the Mini-International Neuropsychiatric Interview (MINI)
- Able and willing to provide informed consent
- Has a desire to reduce their alcohol consumption
- Medical History (medical history form)
- Type 1 diabetes
- History of acute or chronic pancreatitis
- History of diabetic ketoacidosis
- History of proliferative diabetic retinopathy
- History of ascites, advanced liver fibrosis, compensated cirrhosis with portal hypertension, decompensated cirrhosis, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular...
- History of advanced fibrosis or cirrhosis, including (but not limited to) transient elastography (liver stiffness) of \>12 kPa, FIB-4 ≥2.67, ELF ≥9.8, MRE ≥3.63 kPa
- History of stage 3 fibrosis or stage 4 cirrhosis from a liver biopsy
- History of esophageal varices on endoscopy or imaging
- History of nodular liver, cirrhosis, splenomegaly, varices or splenic venous shunting or collaterals on prior imaging
- History or acute alcohol hepatitis (by liver biopsy or elevated bilirubin \> 1.5 times the upper limit of normal)
- History of primary biliary cholangitis
- History of primary sclerosing cholangitis
- Current drug-induced liver disease
- History of alpha1 antitrypsin deficiency related liver disease
- History of autoimmune liver disease
- History of hemochromatosis
- History of Wilson's disease
- Presence of gastroparesis
- History of acute gallbladder disease in the prior 6 months
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Unstable body weight defined as \>5% change in body weight (documented or self-report; intentional or not) in the 90 days prior to randomization
- Recent major cardiovascular event in the 90 days prior to randomization (myocardial infarction, stroke, New York Heart Association class IV heart failure, transient ischemic attack (TIA), or unstable angina
- Known history of prior hypersensitivity reaction to semaglutide, any of the product components, or any other GLP-1 analogue
- Concurrent Treatments (medical history form):
- Current (within the past 30 days) use of pharmacotherapy for alcohol use disorder (AUD), including oral or intramuscular naltrexone, acamprosate, disulfiram, topiramate
- Current (within the past 30 days) use of the following medications with glucose-lowering properties: GLP-1 analogues; sulfonylurea; insulin and insulin products; dipeptidyl peptidase-4 (DPP-4) inhibitors; sodium-glucose...
- Recent changes in dose (within 2 months of randomization) of psychiatric medications (i.e., antidepressants, antianxiety, mood stabilizing)
- Psychiatric diagnosis, the Mini-International Neuropsychiatric Interview (MINI)
- Current serious psychiatric illness (any psychotic disorder, bipolar 1 disorder, psychotic major depression, antisocial personality disorder, bulimia, or anorexia)
- Current DSM-5 diagnosis of a Substance use disorder (SUD), other than moderate-to-severe alcohol, any nicotine, or mild cannabis use disorders
- Other assessments (local site)
- At the time of randomization, moderate-to-severe alcohol withdrawal (Clinical Institute Withdrawal Assessment for Alcohol (CIWA-AR) \>8)
- Body mass index (BMI) \<21 kilograms/square meter (kg/m2)
- Acute high risk of suicide requiring hospitalization at the time of screening or randomization
- Medical, psychiatric, behavioral, or logistical conditions which, in the judgment of the Local Site Investigator (LSI) or Co-Investigator (Co-I), make it unlikely the participant can participate in or complete the...
- Pregnant, actively breastfeeding, or female of childbearing potential who is unwilling to use a highly effective method of contraception as defined by the NIH
- Currently enrolled in another therapeutic or investigational clinical trial without a preexisting dual enrollment agreement
- Participant is incarcerated
- Laboratory
- Hemoglobin A1c (HbA1c)\>10
- Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute (mL/min)
- Albumin \< 3.5 grams/deciliter (g/dl)
- Aspartate aminotransferase (AST) \>3 the Upper Limit of Normal (ULN)
- Alanine aminotransferase (ALT) \>3 the ULN
- Lipase \> 2 times the upper limit of normal
- Alkaline phosphatase \> 1.5 times the ULN
- Total bilirubin \> 1.5 times the ULN except with documented Gilbert's syndrome
- International Normalized Ratio (INR) \> 1.3 unless due to anticoagulation therapy
- Platelet count \<150,000/ liter (L) unless consistent with baseline and reflects the participant's habitual thrombocyte level, and there was no presence of portal hypertension
- Hepatitis B surface antigen positive
- Hepatitis C virus RNA positive - participants treated and cured of hepatitis C must have at least 2 years of negative testing
- Anti-HIV antibody positive test with uncontrolled or unstable treatment
- Positive urine drug screen for substances other than cannabis and prescribed medications
- Positive urine pregnancy test at screening in those considered of childbearing potential
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Palo Alto, California, United States
- West Los Angeles, California, United States
- Orlando, Florida, United States
- Decatur, Georgia, United States
- Hines, Illinois, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Asheville, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Tacoma, Washington, United States
- Madison, Wisconsin, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Palo Alto, California, United States; West Los Angeles, California, United States; Orlando, Florida, United States; Decatur, Georgia, United States; Hines, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.