What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as Semaglutide, are being studied for their potential in treating Alcohol Use Disorder (AUD). Common side effects of GLP-1 receptor agonists include gastrointestinal issues like nausea, vomiting, and diarrhea. There are also concerns about the risk of pancreatitis and potential thyroid C-cell tumors, particularly in individuals with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia. Other common treatments for alcoholism, such as naltrexone and acamprosate, have their own side effects, including nausea, headache, dizziness, and in some cases, liver toxicity. It is important for patients to discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Currently, there are no FDA-approved GLP-1 receptor agonists specifically for the treatment of alcohol use disorder (AUD). The primary FDA-approved medications for AUD include naltrexone, acamprosate, and disulfiram. These medications work through different mechanisms, such as opioid receptor antagonism (naltrexone), modulation of glutamate and GABA systems (acamprosate), and inhibition of aldehyde dehydrogenase (disulfiram). The ongoing clinical trial of semaglutide, a GLP-1 receptor agonist, aims to explore its potential benefits in reducing alcohol cravings and consumption, which could provide a new therapeutic option if proven effective.

What other types of research exist?

Promising novel alternatives to Semaglutide for treating alcoholism in 2024 include Naltrexone, Acamprosate, and Varenicline. Naltrexone is an opioid antagonist that reduces alcohol cravings and consumption. Acamprosate helps maintain abstinence by modulating neurotransmitter systems. Varenicline, primarily used for smoking cessation, has shown potential in reducing alcohol consumption. These alternatives have demonstrated efficacy and safety in clinical trials for AUD.

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GLP-1 Receptor Agonist

Semaglutide for Alcoholism

Phase 2

Recruiting

Led By Joseph P Schacht, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks - change between screening and week 6 visit

Summary

This trial is testing oral semaglutide, a medication taken by mouth, to see if it can help people with Alcohol Use Disorder (AUD) reduce their cravings and drinking. Researchers want to see if semaglutide is safe and if it changes how the brain responds to alcohol cues. Semaglutide was initially developed for the treatment of type 2 diabetes and has shown efficacy in weight loss for individuals with and without diabetes.

Who is the study for?

Adults over 21 with Alcohol Use Disorder seeking treatment, having a BMI of at least 25 kg/m2, and living within 50 miles of the study site. Excluded are those with certain mental health conditions, using specific medications or therapies for AUD or weight control, past use of GLP-1 agonists like semaglutide, severe alcohol withdrawal history, diabetes, kidney disease, gastrointestinal diseases including pancreatitis, uncontrolled hypertension or liver issues.

What is being tested?

The trial tests oral semaglutide (up to 7 mg daily) against a placebo in individuals with AUD for its safety and effects on craving and consumption of alcohol. This is an 8-week randomized controlled trial where participants are chosen by chance to receive either the drug or placebo.

What are the potential side effects?

Semaglutide may cause digestive issues such as nausea and constipation; rare but serious side effects include inflammation of the pancreas (pancreatitis), changes in vision due to retinal damage (diabetic retinopathy), kidney problems including kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks - change between screening and week 6 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks - change between screening and week 6 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks - change between screening and week 6 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cue Craving Visual Analog Score

Secondary study objectives

Change in alcohol cue-elicited brain activation

Number of drinks per day

Percentage of heavy drinking days

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Semaglutide 3 milligrams and 7 milligramsActive Control2 Interventions

Participants in this Arm will study medication for a total of 8 weeks - on semaglutide 3 milligrams per day for 4 weeks, then 7 milligrams per day for 4 weeks. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

Group II: PlaceboPlacebo Group1 Intervention

Participants in this Arm will take a medically inert placebo. To ensure pill equivalence between groups, tablets will be packaged in the same capsule; thus, each participant will take one capsule per day. Participants will be instructed to ingest the capsule orally each morning.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as semaglutide, work by mimicking the incretin hormone GLP-1, which enhances glucose-dependent insulin secretion, slows gastric emptying, and reduces appetite. These mechanisms are significant for alcoholism patients because they can potentially reduce alcohol cravings and consumption by modulating reward pathways and appetite control. This is particularly relevant as the trial aims to assess the effects of semaglutide on alcohol cue-elicited craving and alcohol consumption, offering a novel approach to managing Alcohol Use Disorder (AUD).