What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram. Naltrexone can cause side effects such as nausea, headache, and dizziness. Acamprosate may lead to diarrhea and abdominal pain. Disulfiram can cause drowsiness, headache, and a metallic taste. For GLP-1 receptor agonists like Semaglutide, which are being studied for alcohol use disorder, known side effects include gastrointestinal symptoms such as nausea, vomiting, and diarrhea, as well as potential risks of pancreatitis and thyroid C cell tumors.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for GLP-1 receptor agonists like Semaglutide for the treatment of alcoholism. Generally, FDA-approved treatments for alcohol use disorder include medications such as disulfiram, naltrexone, and acamprosate, which work through different mechanisms to reduce alcohol consumption and dependence. Semaglutide is currently being studied in early-phase trials for its potential effects on alcohol-related outcomes.

What other types of research exist?

Promising novel alternatives to Semaglutide for treating alcoholism in 2024 may include medications like Naltrexone, which targets opioid receptors, and Acamprosate, which modulates glutamate neurotransmission. Additionally, emerging treatments such as Baclofen, a GABA-B receptor agonist, and Varenicline, a partial nicotinic acetylcholine receptor agonist, have shown potential in recent studies. These alternatives offer different mechanisms of action that may be effective for patients with alcohol use disorder.

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GLP-1 Receptor Agonist

Semaglutide for Alcoholism

Q: What is the mechanism of action of this treatment?

The most common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram, each with distinct mechanisms of action. Naltrexone works by blocking opioid receptors, reducing the rewarding effects of alcohol. Acamprosate modulates glutamate neurotransmission, helping to restore the balance of excitatory and inhibitory signals in the brain disrupted by chronic alcohol use. Disulfiram inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant reactions when alcohol is consumed. Semaglutide, a GLP-1 receptor agonist, is being studied for its potential to reduce alcohol consumption by influencing brain pathways related to reward and satiety. Understanding these mechanisms is crucial for tailoring treatments to individual patients, improving adherence, and enhancing outcomes in alcoholism management.

Phase 2

Waitlist Available

Led By Christian Hendershot, Ph.D.

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Age 21-65

Willingness/availability to take study medication and complete study procedures, including attending weekly visits for medication administration, side effect assessments, and glucose monitoring

Must not have

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)

History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0) to study endpoint (week 10)

Summary

This trial is testing semaglutide, a medication that helps control appetite and blood sugar, to see if it can reduce alcohol consumption in adults with alcohol use disorder. Participants will take the medication over several weeks and attend regular visits to monitor their alcohol intake and weight. Semaglutide has been shown to induce weight loss and improve health in individuals with obesity and type 2 diabetes.

Who is the study for?

Adults aged 21-65 who smoke daily, meet criteria for mild or moderate alcohol use disorder (AUD), and drink at risky levels can join this trial. They must be willing to take medication, attend weekly visits, and participate in lab sessions with alcohol administration. Exclusions include regular use of other tobacco products, prior GLP-1 agonist use like semaglutide, current cessation treatments for smoking or drinking, certain medical conditions including uncontrolled hypertension or thyroid disease, history of severe mental illness or cancer within the last five years.

What is being tested?

The trial is testing semaglutide's effects on adults with AUD by comparing it against a placebo. Semaglutide is a drug that affects glucose control and appetite regulation. Participants will receive either the actual drug or a sham treatment randomly and their responses to alcohol consumption will be monitored.

What are the potential side effects?

Semaglutide may cause side effects such as nausea, vomiting, diarrhea, constipation, abdominal pain; low blood sugar; increased heart rate; pancreatitis; gallbladder problems; kidney problems; allergic reactions including swelling under the skin (urticaria); fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 65 years old.

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I am willing and able to follow the study's medication and visit schedule.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have severe liver, kidney, heart, or other major health issues.

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I haven't had cancer, except for some skin cancers or early-stage cancers, in the last 5 years.

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I or my family have a history of specific thyroid cancer or genetic conditions.

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I have had major stomach surgery that could affect medication absorption.

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I have used vaping, cigars, chewing tobacco, or snuff at least once a week in the last month.

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I have diabetes or my HbA1c level was over 6.5% at screening.

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I have a history of serious eye conditions related to diabetes.

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I have used semaglutide or similar medications before.

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I have not taken Sincalide, Sulfonylureas, insulin, semaglutide, or weight control medications in the last 30 days.

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I have not attempted suicide, had thoughts of suicide in the last 30 days, or been hospitalized for psychiatric reasons in the last 6 months.

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I have had diabetic ketoacidosis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) to study endpoint (week 10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0) to study endpoint (week 10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to study endpoint (week 10) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Respiration

Change in Volume of Alcohol Consumed

Secondary study objectives

Change in Alcohol Demand (Alcohol Purchase Task)

Change in Cigarette Demand (Cigarette Purchase Task)

Alcohol Use Disorder

+3 more

Other study objectives

Change in Alcohol elimination

Change in HbA1c

Change in Weight

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 semaglutide via subcutaneous injections at escalating doses (.25mg to 1.0mg) over 9 weeks.

Group II: Sham/PlaceboPlacebo Group1 Intervention

Participants will receive sham subcutaneous injections over 9 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Semaglutide

2021

Completed Phase 4

~5160

0 / 13Eligibility criteria met

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

The most common treatments for alcoholism include medications like naltrexone, acamprosate, and disulfiram, each with distinct mechanisms of action. Naltrexone works by blocking opioid receptors, reducing the rewarding effects of alcohol. Acamprosate modulates glutamate neurotransmission, helping to restore the balance of excitatory and inhibitory signals in the brain disrupted by chronic alcohol use. Disulfiram inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant reactions when alcohol is consumed. Semaglutide, a GLP-1 receptor agonist, is being studied for its potential to reduce alcohol consumption by influencing brain pathways related to reward and satiety. Understanding these mechanisms is crucial for tailoring treatments to individual patients, improving adherence, and enhancing outcomes in alcoholism management.