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

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00001673
Collaborator
(none)
2,220
1
218.4
10.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2220 participants
    Official Title:
    Screening Evaluation for NIAAA Protocols
    Study Start Date :
    Oct 2, 1997
    Study Completion Date :
    Dec 15, 2015

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      • 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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

      Investigators

      • Principal Investigator: Reza Momenan, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      National Institute on Alcohol Abuse and Alcoholism (NIAAA)
      ClinicalTrials.gov Identifier:
      NCT00001673
      Other Study ID Numbers:
      • 980009
      • 98-AA-0009
      First Posted:
      Apr 20, 2006
      Last Update Posted:
      Oct 6, 2017
      Last Verified:
      Dec 15, 2015
      Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Oct 6, 2017