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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 165 minutes
Awards & highlights
Study Summary
This trial is testing GET73, a medication, to see if it can help people who drink alcohol regularly but are not looking for treatment. There will be 4 study visits, including 2 MRIs, for participants who will take GET73 or placebo for 8 days.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 165 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~165 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Gamma aminobutyric acid (GABA) and glutamate levels
Levels of cortical activation to visual cues of alcohol
Number of drinks consumed during bar-lab paradigm (free drinking period)
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
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,545 Total Patients Enrolled
46 Trials studying Alcoholism
5,015 Patients Enrolled for Alcoholism
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,776 Total Patients Enrolled
29 Trials studying Alcoholism
6,911 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,307 Total Patients Enrolled
423 Trials studying Alcoholism
985,618 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for volunteers to partake in this research?
"The details outlined on clinicaltrials.gov indicate that this research is actively recruiting as of 1/5/2022, having initially been posted to the site on 9/15/2021."
Answered by AI
What is the highest quantity of participants enrolled in this research?
"Affirmative, the clinical trial is actively recruiting participants as indicated by its listing on clinicaltrials.gov. This investigation was first publicized on September 15th 2021 and last modified on January 5th 2022, with 90 patients sought from a single location."
Answered by AI
What kind of qualifications are required for participation in this investigation?
"Individuals with alcohol use disorder who are between 21 and 40 years old may be eligible to join this trial. So far, approximately 90 participants have been enrolled."
Answered by AI
Does this trial permit participants that are over 55 years of age?
"To qualify for this clinical trial, patients must fall within the 21-40 age range. Additionally, there are 33 trials available to those below 18 years old and 249 studies for elderly individuals above 65 years of age."
Answered by AI
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