50 Participants Needed

Ethanol for Alcohol-Related Behaviors in Healthy Subjects

VA
Overseen ByVijay A Ramchandani, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Background:Alcohol use disorder (AUD) can damage people s health, work, and family. Researchers want to know more about why some people are more vulnerable to AUD than others. The ZIP8 gene may be linked to an increased risk of AUD. Researchers want to find out how different forms of the ZIP8 gene affect how healthy people drink alcohol and how alcohol affects their brain.Objective:To study how genes may affect how people drink alcohol and how it affects their brain.Eligibility:Healthy people aged 21 to 60 years. They must not smoke, and they must have no history of AUD. They must have European ancestry and be enrolled in Natural History Protocol (14-AA-0181).Design:Participants will have 2 study visits.At the first visit, participants will be given alcohol; it will be infused through a tube attached to a needle inserted into a vein. They may self-administer each dose by pressing a button. Over time, they will have to press the button an increasing number of times to receive more alcohol. The infusion period will last 2.5 hours.Participants will have blood samples taken and breath measurments, and they will do computer tasks and complete questionnaires during and after the infusion. After the infusion, they will remain in the clinic until their breath alcohol levels drop to a safe level.At the second visit, participants will have an imaging scan of their brain. They will do tasks and play games on a computer screen during the scan.Some participants may have an extra visit for screening. A mid-study visit may also be needed if more than 6 months pass between the 2 study visits....

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants using medications that interact with alcohol or affect alcohol metabolism, such as some heart, diabetes, and pain medications. You must refrain from these medications for a specified period before the study.

Is ethanol safe for human use in clinical trials?

The research articles provided do not contain specific safety data for ethanol in humans, as they focus on animal models and the effects of ethanol consumption in mice and monkeys.12345

How does ethanol differ from other treatments for alcohol-related behaviors?

Ethanol is unique because it is the substance being studied for its effects on alcohol-related behaviors, rather than a medication designed to treat alcohol use disorder. Unlike other treatments that aim to reduce alcohol consumption or cravings, this study focuses on understanding ethanol's role in reinforcing drinking behaviors and its interactions with neurotransmitter systems.26789

What data supports the effectiveness of the drug ZIP8 for alcohol-related behaviors?

The research suggests that certain compounds affecting GABA receptors, like the GABAB allosteric modulator GS39783, can reduce alcohol consumption in animal models. This implies that targeting similar pathways might be effective in managing alcohol-related behaviors.1231011

Who Is on the Research Team?

VA

Vijay A Ramchandani, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 21 to 60 with European ancestry who don't smoke and have no history of alcohol use disorder. They must be part of another study (14-AA-0181) and cannot have any conditions that exclude them from safely participating.

Inclusion Criteria

I am between 21 and 60 years old.
Non-smokers with no history of smoking in the past year and not a daily smoker for more than 1 month in their lifetime
Participants of European ancestry
See 2 more

Exclusion Criteria

Current history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders
Lifetime history of psychotic disorders, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or eating disorder
Current or lifetime diagnosis of alcohol or substance use disorder
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Alcohol Infusion and Self-Administration

Participants receive alcohol infusion and may self-administer doses by pressing a button during a 2.5-hour session. Blood samples and breath measurements are taken, and participants complete computer tasks and questionnaires.

1 day
1 visit (in-person)

Imaging and Cognitive Tasks

Participants undergo an imaging scan of their brain and perform tasks and games on a computer screen during the scan.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study visits.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ZIP8
Trial Overview The study investigates how different forms of the ZIP8 gene influence drinking behavior and brain response to alcohol in healthy people. Participants will receive alcohol intravenously, perform computer tasks, answer questionnaires, and undergo a brain imaging scan.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: IV EthanolExperimental Treatment1 Intervention
IV Ethanol

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials
865
Recruited
1,091,000+

Published Research Related to This Trial

Alcohol Use Disorder (AUD) affects over 76 million people globally, and current FDA-approved treatments are largely ineffective, highlighting the need for new therapeutic options.
The study employs two rodent drinking modelsโ€”two-bottle choice (TBC) and drinking in the dark (DID)โ€”to evaluate the effectiveness of new anti-alcohol compounds, providing a rapid and efficient way to screen potential treatments.
Murine Drinking Models in the Development of Pharmacotherapies for Alcoholism: Drinking in the Dark and Two-bottle Choice.Huynh, N., Arabian, NM., Asatryan, L., et al.[2022]
The benzodiazepine partial inverse agonist RO19-4603 significantly reduced ethanol (EtOH) intake in alcohol-preferring rats, with effective doses as low as 0.009 mg/kg, demonstrating both immediate and prolonged effects on drinking behavior over two days.
The study suggests that RO19-4603 may offer a potential therapeutic approach for reducing alcohol consumption, as it selectively decreased EtOH intake without affecting saccharin or food intake, indicating a targeted effect on alcohol reinforcement.
Effects of the benzodiazepine inverse agonist RO19-4603 alone and in combination with the benzodiazepine receptor antagonists flumazenil, ZK 93426 and CGS 8216, on ethanol intake in alcohol-preferring (P) rats.June, HL., Greene, TL., Murphy, JM., et al.[2017]

Citations

Alterations in the rate of binge ethanol consumption: implications for preclinical studies in mice. [2021]
Murine Drinking Models in the Development of Pharmacotherapies for Alcoholism: Drinking in the Dark and Two-bottle Choice. [2022]
Effects of the benzodiazepine inverse agonist RO19-4603 alone and in combination with the benzodiazepine receptor antagonists flumazenil, ZK 93426 and CGS 8216, on ethanol intake in alcohol-preferring (P) rats. [2017]
GABAA Receptor Subtypes and the Abuse-Related Effects of Ethanol in Rhesus Monkeys: Experiments with Selective Positive Allosteric Modulators. [2020]
Effects of gamma-aminobutyric acid agonists and N-methyl-D-aspartate antagonists on a multiple schedule of ethanol and saccharin self-administration in rats. [2013]
Evaluation of a simple model of ethanol drinking to intoxication in C57BL/6J mice. [2022]
Effects of Tacrolimus and Other Immune Targeting Compounds on Binge-Like Ethanol Drinking in High Drinking in the Dark Mice. [2023]
Behavioral, neurobiological, and neurochemical mechanisms of ethanol self-administration: A translational review. [2021]
Ethanol as a reinforcer: a review of laboratory studies of non-human primates. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Testing pharmacotherapies for alcohol use disorder with cue exposure paradigms: A systematic review and quantitative synthesis of human laboratory trial methodology. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Ethanol consumption: how should we measure it? Achieving consilience between human and animal phenotypes. [2021]
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