NIAAA Natural History Protocol

Recruiting now

Conditions studied: Alcohol Use Disorder

In brief

Background: \- About 17 million adults had an alcohol use disorder in 2012. Researchers want to follow people that have alcohol problems and want treatment, as well as those who do not want treatment and healthy volunteers. They also want to gather information on people with and without alcohol problems, including information on genes and biological processes in the body.. This will help them better understand, prevent, and treat alcohol problems. Objective: -To look at a broad range of traits in people who are healthy people and people with alcohol problems. To study them for potential eligibility for other research protocols conducted at the NIH Clinical Center. Eligibility: * Adults age 18 and older. * Not being pregnant or imprisoned. Design: * Participants will have a physical exam. They will answer questions about their health and alcohol and drug use. They will have an electrocardiogram to check their heart. They will have blood, urine, and breath alcohol tests. * Participants without alcohol problems, or who have them but do not want treatment, can sign the second consent for screening and research. * Participants that have alcohol problems and want treatment will be treated at the NIH Clinical Center. They will be offered to sign the second consent at a later time. * Participants may join an inpatient treatment and detox program. It could last up to 6 weeks. Or they may join an outpatient program. Some may do both. * After discharge, participants may be called and asked questions about their drinking and health. * If participants sign the second consent, they: * will complete paper- and computer-based questionnaires. * will give blood samples. * may have a brain scan using magnetic resonance imaging. They will lie on a table that slides in and out of a cylinder that takes pictures. The machine makes loud noises. They will get earplugs.

Key facts

Study ID

NCT02231840

Run by

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

People needed

7500

Starts

2015-01-21

Expected to finish

2044-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• This is a natural history protocol of alcohol use as a continuum. Potential participants are pre-screened on the phone and, based on the information provided on the phone, the following categories are excluded because they are not suitable study participants for this protocol:
• Individuals < 18 years of age
• Prisoners
• Pregnant candidates
• Candidates having a severe medical or mental health disorder that would impair participation in the study
• All participants are initially phone-screened for eligibility: age, legal status, pregnancy, and severe medical conditions will be assessed using information reported in the phone screen to determine eligibility for the study.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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