Healthy Clinical Trial
Official title:
Screening Evaluation for NIAAA Protocols
This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from
other NIAAA protocols; (2) to provide a common set of descriptive information that will be
available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to
treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before
requiring patients to consent to evaluation for participation in research studies.
Information collected will include such items as psychiatric diagnoses, presence or absence
of brain, liver or other organ damage, history of the amount of past alcohol consumption,
other substance use and family history of alcoholism. This information will allow
investigators to determine for which, if any, NIAAA research studies a subject is eligible.
In order to avoid requiring intoxicated subjects to consent for procedures such as HIV
testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will
obtain consent from all alcoholic subjects in two phases, using two separate consent forms.
The first consent form will express the subject's desire to be admitted to the NIAAA
inpatient unit for the purpose of treatment for alcoholism and will authorize only medical
evaluation and treatment for alcoholism and associated problems. After an alcoholic subject
has been admitted to the inpatient unit and is judged to be no longer intoxicated or
suffering from acute alcohol withdrawal he or she will be presented with the second consent
which will describe the evaluation for participation in other NIAAA research studies.
Non-alcoholic, healthy controls will sign only one consent form describing the data to be
collected and evaluation for participation in other NIAAA research studies.
This protocol has three purposes:
1. to evaluate non-treatment seeking participants for inclusion or exclusion from other
NIAAA protocols. Non-treatment seeking participants includes individuals with no current
or past alcohol use disorder, as well as individuals who meet the DSM IV criteria for
alcohol abuse or alcohol dependence (alcohol use disorders (AUD) but are not seeking
treatment;
2. to provide a common set of descriptive information that will be available on all NIAAA
research participants;
3. to collect blood samples from participants for the purpose of genetic analyses
Information collected will include such items as psychiatric diagnoses, genotypes of several
neurotransmitter-related and brain growth-related candidate genes, presence or absence of
brain, liver or other organ damage, history of the amount of past alcohol consumption, other
substance use and family history of alcoholism. This information will allow investigators to
determine for which, if any, NIAAA research studies a subject is eligible. It will also allow
investigators to examine the relationship among various candidate genes and brain structure
and/or function in alcoholism.
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