Protocol Number: 98-AA-0009

Title:

Screening Evaluation for NIAAA Protocols

Number:

98-AA-0009

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.

Sponsoring Institute:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Subjects and volunteers can call (301) 496-1993 for more information regarding this protocol.

Keywords:

Alcoholics

Screening

Healthy Volunteers

Violent Abusers

Blood tests

Illicit drug testing

Recruitment Keyword(s):

Normal Volunteer

Condition(s):

Alcoholic Intoxication

Alcoholism

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute on Alcohol Abuse and Alcoholism

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Koob GF, Nestler EJ. The neurobiology of drug addiction. J Neuropsychiatry Clin Neurosci. 1997 Summer;9(3):482-97. Review.

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. Review.

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.

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