Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized Controlled Trial for Alcohol Use Disorder (CRAVE)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Office of Research and Development

About this trial

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. Participants receiving semaglutide will start with a low dose, gradually increasing to a maximum of 2.4 milligrams (mg) per week, depending on their tolerance. The primary measure of success will be a reduction in risky drinking, assessed through a reliable calendar-based interview method called the Timeline Follow-Back (TLFB), a well-validated calendar-based interview technique for recording daily alcohol consumption. The purpose of this research is to gather information on the safety and effectiveness of semaglutide for treating AUD, potentially offering a new and more appealing treatment option.

Eligibility criteria

Qualifiers

Veteran

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 AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria) based on semi-structured diagnostic exam (MINI)

Able and willing to provide informed consent

Disqualifiers

Medical History (medical history form)

Type 1 diabetes

History of acute or chronic pancreatitis

History of diabetic ketoacidosis

Trial design

Treatments tested in this trial

  • Semaglutide
  • Placebo

Treatment groups

622 Participants
are divided into 2 treatment groups