NIAAA Natural History Protocol

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age >=18 years of age

Willingness to complete the study including genetic and MRI tests.

Treatment-seeking individuals (Patients that want to stop alcohol use and will require medical management to achieve sobriety) and

Non-treatment-seeking participants (Patients or healthy volunteers who want to continue their current alcohol use).

Disqualifiers

Individuals < 18 years of age

Prisoners

Pregnant candidates

Candidates having a severe medical or mental health disorder that would impair participation in the study

Trial population

We will enroll a total of 7500 participants. Any individual (Bullet)18 years of age who expresses interest in participating in this study and/or other research studies offered at NIAAA during the brief telephone pre-screening may be enrolled. Participants may be individuals with no current or past AUD, as well as individuals who meet current or past DSM criteria for AUD. Healthy volunteers and other volunteers will also be enrolled in this protocol.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

7,500 Participants
are grouped into 2 trial groups
Group A: Not treatment-seeking participants
Group B: Treatment-seeking Patients

Trial outcomes

Primary outcomes

1

Obtain phenotypic assessments

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

Time frame
CROSS SECTIONAL

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.