What is the mechanism of action of this treatment?

GLP-1 receptor agonists, such as Semaglutide, work by mimicking the incretin hormone GLP-1, which enhances insulin secretion, inhibits glucagon release, and slows gastric emptying. These effects help regulate blood sugar levels and may also influence brain pathways related to reward and addiction, potentially reducing alcohol consumption. Other common treatments for alcoholism include naltrexone, which blocks opioid receptors to reduce the pleasurable effects of alcohol, and acamprosate, which modulates glutamate neurotransmission to stabilize brain activity. These treatments are crucial for alcoholism patients as they target different aspects of addiction, helping to reduce cravings and prevent relapse.

What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as semaglutide, liraglutide, and exenatide, are primarily used for diabetes management but are being studied for alcohol reduction. Common side effects include gastrointestinal symptoms like nausea, vomiting, and diarrhea. There are also concerns about potential risks of pancreatitis and thyroid C-cell tumors, although these are rare. For alcoholism treatments in general, medications like naltrexone and acamprosate are commonly used, with side effects including nausea, headache, and dizziness for naltrexone, and diarrhea and anxiety for acamprosate.

What prior FDA approvals exist?

As of now, there are no FDA-approved GLP-1 receptor agonists specifically for the treatment of alcoholism. However, Semaglutide, a GLP-1 receptor agonist, is being studied for its potential in reducing alcohol consumption. Current FDA-approved treatments for alcoholism include medications such as disulfiram, naltrexone, and acamprosate, which work through different mechanisms to reduce alcohol dependence and cravings.

What other types of research exist?

Promising novel alternatives to Semaglutide for treating alcoholism in 2024 include Naltrexone, an opioid receptor antagonist that reduces alcohol cravings, and Acamprosate, which modulates glutamatergic neurotransmission to maintain abstinence. Additionally, emerging treatments like Baclofen, a GABA-B receptor agonist, and Varenicline, a nicotinic acetylcholine receptor partial agonist, show potential in reducing alcohol consumption. Ongoing research into the use of psychedelic-assisted therapy, such as Psilocybin, also holds promise for future treatment options.

← Back to Search

Semaglutide for Alcoholism (STAR-T Trial)

Phase 2

Recruiting

Led By William K Simmons, Ph.D.

Research Sponsored by Oklahoma State University Center for Health Sciences

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 baseline (week 1) to post-medication (week 13

Summary

This trial is testing if semaglutide, an injection given regularly, can help people with alcohol use disorder reduce their drinking. The medication might work by influencing the brain's reward system and appetite control. Semaglutide was originally approved for the treatment of type 2 diabetes and obesity, and has shown efficacy in weight loss.

Who is the study for?

This trial is for adults with Alcohol Use Disorder who drink more than a moderate amount weekly and can consent to the study. They must be in stable health, not have certain mental health conditions or hearing loss, and women should use effective birth control. People with diabetes, severe kidney issues, high triglycerides, or those on specific medications cannot join.

What is being tested?

The study tests if semaglutide can safely reduce alcohol consumption compared to a placebo (a substance with no therapeutic effect). Participants will receive either the actual drug or placebo without knowing which one they are getting.

What are the potential side effects?

Semaglutide may cause side effects like nausea, headache, digestive problems, low blood sugar levels (in people with diabetes), and possible allergic reactions. Not everyone will experience these side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1) to post-medication (week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1) to post-medication (week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1) to post-medication (week 13 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 alcohol drinking

Secondary study objectives

Change in blood phosphatidylethanol (PEth) levels as a biomarker of alcohol use

Change in drinks per drinking days

Change in heavy drinking days

+5 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848

21%

Nausea

12%

Decreased Appetite

100%

80%

60%

40%

20%

Study treatment Arm

Overall Study

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SemaglutideExperimental Treatment1 Intervention

Participants will receive subcutaneous injections of semaglutide in escalating doses (.25mg to 1.0mg) over the course of 12 weeks.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive subcutaneous injections of a placebo saline solution over the course of 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

Do I qualify?Apply below to find out

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 insulin secretion, inhibits glucagon release, and slows gastric emptying. These effects help regulate blood sugar levels and may also influence brain pathways related to reward and addiction, potentially reducing alcohol consumption. Other common treatments for alcoholism include naltrexone, which blocks opioid receptors to reduce the pleasurable effects of alcohol, and acamprosate, which modulates glutamate neurotransmission to stabilize brain activity. These treatments are crucial for alcoholism patients as they target different aspects of addiction, helping to reduce cravings and prevent relapse.