Ethanol for Alcohol-Related Behaviors in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why some individuals might be more prone to alcohol use disorder (AUD) by studying a specific gene called ZIP8. Researchers will examine how different forms of this gene influence alcohol consumption and its effects on the brain. Participants will attend two visits, receive alcohol through an IV, and undergo brain scans. Healthy individuals of European ancestry who drink alcohol but do not have a history of alcohol-related issues are suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a unique opportunity to contribute to groundbreaking genetic research.
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 there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that receiving alcohol directly into the bloodstream through an IV affects the body in several ways. Some studies suggest it might slightly increase heart rate, body temperature, and blood pressure. Other reports mention it can cause feelings of restlessness and mood changes. These effects occur more often in people who have recently consumed alcohol.
It's important to remember that alcohol is widely used, and its effects are generally well-known. However, receiving it through an IV may feel different than drinking it. Participants in such trials are closely monitored to ensure their safety.12345Why are researchers excited about this trial?
Unlike other treatments for alcohol-related behaviors, which typically focus on behavioral therapies and medications like naltrexone or acamprosate, ZIP8 involves the use of IV ethanol. This approach is unique because it directly administers ethanol, the substance involved in alcohol use, in a controlled setting to understand its effects on behavior. Researchers are excited about this treatment because it could offer new insights into how alcohol influences behavior, potentially leading to innovative strategies for managing alcohol-related conditions.
What evidence suggests that this trial's treatments could be effective for understanding alcohol-related behaviors?
Research has shown that administering alcohol through an IV can mimic the effects of drinking alcohol, but in a controlled setting. In studies, participants reported that small amounts of IV alcohol felt like consuming just over one drink, while larger amounts felt like almost two drinks. This method allows researchers to study alcohol's impact on the brain and behavior without requiring participants to drink. In this trial, researchers also examine the ZIP8 gene to determine how genetic differences might influence alcohol use and its effects on the brain. The primary goal of this research is to understand these effects, not to test treatments.25678
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Imaging and Cognitive Tasks
Participants undergo an imaging scan of their brain and perform tasks and games on a computer screen during the scan.
Follow-up
Participants are monitored for safety and effectiveness after the main study visits.
What Are the Treatments Tested in This Trial?
Interventions
- ZIP8
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead Sponsor