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

This study is currently recruiting participants.
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001673
First received: November 3, 1999
Last updated: April 15, 2014
Last verified: March 2014
  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

Study Type: Observational
Official Title: Screening Evaluation for NIAAA Protocols

Resource links provided by NLM:


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

Estimated Enrollment: 2200
Study Start Date: October 1997
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  2. Have ferromagnetic objects in their bodies, which might be adversely affected by MRI (e.g., surgical clips, metal fragments in or near brain, eye or blood vessels, cardiac or neurological pacemaker, cochlear or eye implant). Any doubt about presence of these objects will result in exclusion from this study.
  3. Extreme claustrophobia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001673

Contacts
Contact: Claire L Mann (301) 496-7513 manncl@mail.nih.gov
Contact: Reza Momenan, Ph.D. (301) 496-6540 rezam@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Rabina Joshi    301-402-5360    rabina.joshi@nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Reza Momenan, Ph.D. National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001673     History of Changes
Other Study ID Numbers: 980009, 98-AA-0009
Study First Received: November 3, 1999
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Alcoholics
Screening
Healthy Volunteers
Violent Abusers
Illicit Drug Testing
Blood Tests
Normal Volunteer

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014