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

Primary Purpose

Alcoholic Intoxication, Alcoholism, Healthy

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Alcoholic Intoxication focused on measuring Alcoholics, Screening, Healthy Volunteers, Violent Abusers, Illicit Drug Testing, Blood Tests, Normal Volunteer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: In good health. Over 18 years of age. Not seeking treatment for alcohol or other drug use. EXCLUSION CRITERIA: 1) Serious medical conditions that require ongoing treatment.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
October 5, 2017
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00001673
Brief Title
Screening Evaluation for Studies of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official Title
Screening Evaluation for NIAAA Protocols
Study Type
Observational

2. Study Status

Record Verification Date
December 15, 2015
Overall Recruitment Status
Completed
Study Start Date
October 2, 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 15, 2015 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. 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.
Detailed Description
This protocol has three purposes: 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; to provide a common set of descriptive information that will be available on all NIAAA research participants; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Intoxication, Alcoholism, Healthy
Keywords
Alcoholics, Screening, Healthy Volunteers, Violent Abusers, Illicit Drug Testing, Blood Tests, Normal Volunteer

7. Study Design

Enrollment
2220 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: In good health. Over 18 years of age. Not seeking treatment for alcohol or other drug use. EXCLUSION CRITERIA: 1) Serious medical conditions that require ongoing treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Momenan, Ph.D.
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9276849
Citation
Koob GF, Nestler EJ. The neurobiology of drug addiction. J Neuropsychiatry Clin Neurosci. 1997 Summer;9(3):482-97. doi: 10.1176/jnp.9.3.482.
Results Reference
background
PubMed Identifier
11329486
Citation
Heinz A, Mann K, Weinberger DR, Goldman D. Serotonergic dysfunction, negative mood states, and response to alcohol. Alcohol Clin Exp Res. 2001 Apr;25(4):487-95.
Results Reference
background
PubMed Identifier
9812115
Citation
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. doi: 10.1176/ajp.155.11.1544.
Results Reference
background

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

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