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


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Alcohol Use, Abuse, And Alcoholism

Alcohol addiction; Alcoholism 




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

This study is currently recruiting patients.
Verified by National Institutes of Health Clinical Center (CC) October 2006

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001673

Purpose

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.

Condition
Alcoholic Intoxication
Alcoholism
Healthy

MedlinePlus related topics:  Alcoholism;   Drug Abuse

Study Type: Observational
Study Design: Natural History

Official Title: Screening Evaluation for NIAAA Protocols

Further study details as provided by National Institutes of Health Clinical Center (CC):

Total Enrollment:  2200

Study start: October 1997

This protocol has three purposes: (1) to evaluate control (non-alcoholic) 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 collect blood samples from control and alcoholic subjects 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria
  • INCLUSION CRITERIA:

Non-alcoholic control participants defined as individuals who have never in their life met DSM IV criteria for alcohol dependence or alcohol abuse.

Violent abusers, defined as individuals with or without alcohol-related disorders who report having repeated episodes of physical violence directed at another person and who are enrolled in protocol 01-AA-0098, The Effect of Fluoxetine on Measures of Domestic Violence.

Alcoholics, defined as individuals who meet DSM IV criteria for alcohol dependence or alcohol abuse and who have been enrolled in protocol 05-AA-0121.

EXCLUSION CRITERIA:

Individuals under the age of 18 years of age. We have decided to exclude children from this protocol because NIH Clinical Center currently does not have any inpatient units capable of treating substance-abusing patients who are under the age of 18. NIH Clinical Center regulations require that children be treated on inpatient units which do not also house adult patients. Such facilities are not available to NIAAA.

Participants with serious medical conditions that require ongoing treatment such as diabetes or hypertension.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00001673

Patient Recruitment and Public Liaison Office      (800) 411-1222    prpl@mail.cc.nih.gov
TTY      1-866-411-1010 

United States, Maryland
      National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda,  Maryland,  20892,  United States; Recruiting

More Information

NIH Clinical Center Detailed Web Page

Publications

Heinz A, Ragan P, Jones DW, Hommer D, Williams W, Knable MB, Gorey JG, Doty L, Geyer C, Lee KS, Coppola R, Weinberger DR, Linnoila M. Reduced central serotonin transporters in alcoholism. Am J Psychiatry. 1998 Nov;155(11):1544-9.

Study ID Numbers:  980009; 98-AA-0009
Last Updated:  April 27, 2007
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001673
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 14, 2007

Resources



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November 28, 2009



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