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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 belowSelect...
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:Select...
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.
Select...
I am currently taking medication for mental health or seizures.
Select...
I am not pregnant, nursing, and I use reliable birth control.
Select...
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
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
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.
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
969 Previous Clinical Trials
7,399,267 Total Patients Enrolled
46 Trials studying Alcoholism
5,001 Patients Enrolled for Alcoholism
National Institutes of Health (NIH)NIH
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8,159,559 Total Patients Enrolled
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7,778 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
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1,082,771 Total Patients Enrolled
456 Trials studying Alcoholism
823,683 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on medication that influences how much alcohol I drink.I am willing to drink alcohol mixed with fruit juice.You have been consistently drinking at least 20 standard alcoholic drinks per week for the past 3 months.I have a neurological condition or had a head injury that made me unconscious for more than 2 minutes.I am currently taking medication for mental health or seizures.You have had previous medical problems related to alcohol, like bleeding in the stomach or intestines, inflammation of the pancreas, or ulcers in the stomach.I am not seeking treatment for alcohol-related issues.You have experienced severe symptoms when stopping alcohol in the past, such as shaking, sweating, anxiety, seizures, or confusion.I am not pregnant, nursing, and I use reliable birth control.I have been diagnosed with a mental health condition like depression or schizophrenia.I haven't used drugs except for marijuana and nicotine recently.I don't have major health issues that would stop me from joining the trial or taking its medication.You currently have thoughts of hurting yourself or others.My liver tests are more than 2.5 times the normal level.I am not taking any drugs that affect CYP2C19 or CYP3A4 enzymes.I am between 21 and 40 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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