NIAAA Natural History Protocol
- Conditions
- Alcohol Use Disorder
- Registration Number
- NCT02231840
- Lead Sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Brief Summary
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.
- Detailed Description
Study Description:
This study represents the natural history protocol for NIAAA with the main objectives of providing deep phenotyping of patients across the alcohol use spectrum. This includes Alcohol Use Disorders (AUD) patients, patients with problematic drinking, social drinking, and patients who are abstinent (healthy volunteers, and other volunteers). We have two groups in this study. Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and non-treatment-seeking participants (Patients who want to continue their current alcohol use). A standard set of data will be collected in all patients allowing us to study the impact of alcohol use in their overall health.
Primary Objective:
To gather a set of characterization measures, including a standardized dataset of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes.
Primary Endpoint:
A standardized set of data collected consistently under this protocol that will allow exploratory, descriptive, or correlational studies of alcohol use and AUD.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Obtain phenotypic assessments CROSS SECTIONAL To gather characterization measures for individuals wishing to participate in this protocol, including a standardized set of clinical, behavioral, biochemical, and structural MRI-based phenotypic assessments, as well as whole genome genotypes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States