NIAAA Natural History Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-21

Study Completion Date

2044-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alcoholism Assessment and Treatment

NCT00106093

Alcoholism Alcohol Dependence Alcohol Drinking Related Problems

COMPLETED

Screening Evaluation for Studies of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NCT00001673

Alcoholic Intoxication Alcoholism Healthy

COMPLETED

Addictions Neuroclinical Assessment (ANA)

NCT04946851

Normal Physiology Alcohol Use Disorder

ENROLLING_BY_INVITATION

Nicotinic Receptor Genetic Variation and Alcohol Reward

NCT03294460

Alcohol Drinking

RECRUITING PHASE1

Intravenous Alcohol Administration Using BrAc Method in Healthy Subjects With and Without a Family History of Alcoholism

NCT00612352

Alcoholism

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Not treatment-seeking participants

Individuals who meet current or past DSM 5 criteria for AUD but are not seeking treatment. Healthy volunteers and other volunteers.

No interventions assigned to this group

Treatment-seeking Patients

Individuals who meet current DSM 5 criteria for AUD and are seeking treatment for it.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

As this is a natural history protocol of alcohol use as a continuum, in order to be eligible to participate in this study, an individual must meet the following criterion:

* Age \>=18 years of age
* Willingness to complete the study including genetic and MRI tests.

We will assign participants to one of 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 or healthy volunteers who want to continue their current alcohol use).

All participants are initially phone-screened for eligibility and their desire for treatment of AUD (or lack of it) will determine their group allocation. Their self-report of health status, pregnancy, legal status, and willingness to complete the study including the genetics and MRI test will be assessed in the phone screen and determine eligibility.

Exclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes