What side effects are associated with this type of intervention?

Common treatments for alcoholism with neurological effects include medications like naltrexone, acamprosate, and disulfiram. Naltrexone can cause side effects such as nausea, headache, dizziness, and fatigue. Acamprosate may lead to diarrhea, anxiety, and insomnia. Disulfiram can cause drowsiness, headache, and a metallic or garlic-like taste in the mouth. These medications aim to reduce cravings and withdrawal symptoms but can have varying neurological and gastrointestinal side effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, focusing on neurological effects to reduce alcohol consumption. These include disulfiram, which causes unpleasant reactions when alcohol is consumed; naltrexone, which blocks the euphoric effects of alcohol; and acamprosate, which helps to stabilize brain chemistry that is disrupted by alcohol withdrawal. These treatments aim to reduce cravings and support abstinence. GET73, currently under investigation, also targets neurological pathways to potentially reduce alcohol consumption, similar to these approved treatments.

What other types of research exist?

Promising novel alternatives to GET73 for alcoholism treatment in 2024 include: 1) Naltrexone and Acamprosate, which are well-established but continue to be refined in their application. 2) Baclofen, a GABA-B receptor agonist, showing promise in reducing alcohol cravings. 3) Varenicline, typically used for smoking cessation, has shown potential in reducing alcohol consumption. 4) Neuromodulation techniques such as Transcranial Magnetic Stimulation (TMS) and Deep Brain Stimulation (DBS) are being explored for their efficacy in reducing alcohol cravings and consumption. 5) Emerging therapies targeting the gut-brain axis, such as probiotics and specific dietary interventions, are also under investigation for their potential benefits in treating AUD.

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CD73 inhibitor

GET73 for Alcoholism

Phase 1 & 2

Recruiting

Led By James Prisciandaro

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

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

Must have

Currently not engaged in, and does not want treatment for, alcohol-related problems

Be between 18 and 65 years old

Must not have

Currently taking medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, topiramate)

Neurological disease or history of head injury with > 2 minutes of unconsciousness.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 7

Summary

This trial tests a drug called GET73 on people who drink alcohol regularly but aren't looking for treatment. Participants will take the drug for a short period and have several study visits.

Who is the study for?

This trial is for individuals aged 21-40 with a current Alcohol Use Disorder of at least moderate severity, who drink on average at least 20 alcoholic drinks per week. They must live within 50 miles of the study site and be able to abstain from alcohol before appointments. Exclusions include use of certain drugs, major psychiatric disorders, significant medical issues, pregnancy or not using birth control, pending violent crime charges, metal in body preventing MRI scans, severe claustrophobia or obesity.

What is being tested?

The study tests GET73's effects on regular alcohol drinkers who aren't seeking treatment. Participants will take either GET73 or a placebo over an eight-day period and attend four study visits that include two MRI scans to observe any changes in brain activity related to alcohol consumption.

What are the potential side effects?

While specific side effects are not listed here for GET73 or the placebo, common concerns may involve reactions similar to other medications affecting brain chemistry such as headaches, dizziness, nausea or changes in mood and behavior.

Eligibility Criteria

Inclusion Criteria

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

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I am not seeking treatment for alcohol-related issues.

Exclusion Criteria

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

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I am on medication that influences how much alcohol I drink.

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I have a neurological condition or had a head injury that made me unconscious for more than 2 minutes.

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I am currently taking medication for mental health or seizures.

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I am not pregnant, nursing, and I use reliable birth control.

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I have been diagnosed with a mental health condition like depression or schizophrenia.

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I haven't used drugs except for marijuana and nicotine recently.

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My liver tests are more than 2.5 times the normal level.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 7 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 Gamma aminobutyric acid (GABA) and glutamate levels

Levels of cortical activation to visual cues of alcohol

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group BExperimental Treatment1 Intervention

Group II: Group APlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GET73

2018

Completed Phase 2

~30

0 / 8Eligibility 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

Common treatments for alcoholism often target neurological pathways to reduce alcohol consumption and prevent relapse. Naltrexone works by blocking opioid receptors, which reduces the rewarding effects of alcohol and decreases cravings. Acamprosate modulates glutamate and GABA neurotransmission, helping to restore the balance disrupted by chronic alcohol use, thus reducing withdrawal symptoms and cravings. Disulfiram inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant effects when alcohol is consumed, thereby deterring drinking. These treatments are crucial for patients as they address the neurological underpinnings of addiction, making it easier to maintain sobriety and improve overall quality of life.