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

Screening Evaluation for NIAAA Protocols

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00001673
Enrollment
2220
Registered
2006-04-20
Start date
1997-10-02
Completion date
2015-12-15
Last updated
2017-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Intoxication, Alcoholism, Healthy

Keywords

Alcoholics, Screening, Healthy Volunteers, Violent Abusers, Illicit Drug Testing, Blood Tests, Normal Volunteer

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: 1. In good health. 2. Over 18 years of age. 3. Not seeking treatment for alcohol or other drug use.

Exclusion criteria

1\) Serious medical conditions that require ongoing treatment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026