Unit and Clinic Evaluation, Screening, Assessment, and Management

This study represents the natural history protocol for NIAAA with the main objectives of
providing assessment, clinical care, evaluation, characterization and screening. The specific
goals of this protocol are the following:

- To provide clinical care, including but not limited to medically assisted withdrawal
from alcohol ( detoxification ), as well as standard behavioral and/or pharmacological
therapies where indicated to those who wish to receive treatment for alcohol use
disorders (AUD) and related clinical conditions.

- To gather characterization measures for individuals wishing to participate in this
protocol and in future NIH protocols (for which this protocol serves as the screening
protocol), including a standardized set of clinical, behavioral, biochemical and
structural MRI-based phenotypic assessments, as well as whole genome genotypes

- To screen and evaluate individuals wishing to participate in NIH clinical protocols
(both those providing treatment and those that do not provide treatment for AUD) for
which the present protocol serves as the screening platform. 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.

- Finally, this protocol may also serve for training purposes, as it may provide
opportunities for training of fellows and other staff members of the NIAAA Clinical
Programs.

- ANA Substudy objective: To obtain assessments built around three neuroscience domains,
incentive salience, negative emotionality, and executive function, related to addiction
for purposes of identifying neuroscience-based, clinically-relevant subtypes of alcohol
use disorder and alcohol use patterns

We will collect information including such items as psychiatric diagnoses and symptoms,
biomarkers of liver and other organ damage, quantitative alcohol use history, other substance
use, and family history of alcoholism. Using this information, investigators will be able to
clinically manage any disorders in need of clinical attention, and determine whether subjects
are eligible for any NIH research studies (for which this protocol serves as the screening
platform) based on results of screening evaluations and the participants interest in
receiving treatment for AUD. We will also acquire whole genome data, with which investigators
will be able to examine the relationship between genetic variation and alcohol-related
phenotypes.

Consenting for this protocol will be a two-step process. The first consent (named Clinical
Management Consent) will allow Investigators to assess the acute needs and provide
appropriate clinical care. The second consent (named Screening and Research Consent) will
allow Investigators to conduct screening and research data collection and analysis.The
substudy will have its own consent, the Addictions Neuroclinical Assessment (ANA) consent.

- INCLUSION CRITERIA:

Any individual with greater than or equal to 18 years of age who expressed interest in
participating in this study and/or other research studies offered at NIAAA during the brief
telephone pre-screening may be enrolled. Age is verified at the NIH Clinical Center (CC)
Admissions team at the time the patient signs the NIH Clinical Center General Admission
Consent. This is standard operating procedure at the NIH CC for both outpatient and
inpatient participants.

EXCLUSION CRITERIA:

Given that this is a screening protocol, there are no exclusion criteria per se that apply
after a participant signs the Clinical Management consent. In fact, we will evaluate
participants (including medical and psychiatric evaluations) only after the first-step
Clinical Management Consent form is signed. However, 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:

- Women who are pregnant

- Individuals < 18 years of age

- Prisoners

- Exclusionary for ANA substudy: positive breath alcohol test (BrAC) on the day(s) of
testing

It is important to keep in mind that after participants sign the consent, new information
may be made available during the study that can lead the Investigators to withdraw a
participant. For example, a participant may have a positive pregnancy test (i.e., she was
not aware or did not report during the telephone pre-screening). In this case, the
participant will be referred to appropriate care that can best manage and follow-up with
their specific clinical needs. Another scenario may be that a participant may be arrested
during their participation in the study based on new found information obtained by proper
authorities (including NIH Police); in this case, a member of the NIH Clinical Center
Social Worker Department will be notified.

Finally, at the time of the consent process, those participants who are unable to complete
all of the questions in the NIDA/NIAAA Evaluation of Potential Research Participants
Ability to Consent will not be enrolled (i.e., they will not sign the consent form) and
will be referred for appropriate care.