Screening Evaluation for Studies of the National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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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 |
| Estimated Enrollment: | 2200 |
| Study Start Date: | October 1997 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
- In good health.
- Over 18 years of age.
- Not seeking treatment for alcohol or other drug use.
EXCLUSION CRITERIA:
- Serious medical conditions that require ongoing treatment.
- 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.
- Extreme claustrophobia.
Contacts and Locations| Contact: Reza Momenan, Ph.D. | (301) 496-6540 | rezam@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| 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 25, 2013 |
| 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 May 22, 2013