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Recruiting Phase 1 NCT06819189

Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors

Trial Parameters

Condition Healthy Volunteer
Sponsor National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 50
Sex ALL
Min Age 21 Years
Max Age 60 Years
Start Date 2025-06-10
Completion 2027-12-31
Interventions
Ethanol

Brief Summary

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....

Eligibility Criteria

* INCLUSION CRITERIA: 1. Male and female participants between 21-60 years of age. \[Based on: identification provided to Clinical Center Admissions office\]. 2. Non-smokers with no history of smoking in the past year and not a daily smoker for more than 1 month in their lifetime. \[Based on: smoking history questionnaire, Additional History Form\] 3. Participants of European ancestry: the minor T allele of rs13107325, has a frequency of 0.08 in European ancestry, but is almost absent in Asian and African populations (http://www.ensembl.org). Due to the rare occurrence of the T allele and to avoid populations stratification in this small sample-sized study, only participants with self-reported White racial category (European ancestry) will be enrolled in this study. 4. Inclusion criteria for persons of childbearing potential: Use of adequate method of birth control during the study, if participant is sexually active and is not surgically sterilized. Adequate methods of contraception inc

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