Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001673
Status:
COMPLETED
Last Update Posted:
2017-10-06
First Post:
1999-11-03
Brief Title:
Screening Evaluation for Studies of the National Institute on Alcohol Abuse and Alcoholism NIAAA
Sponsor:
National Institute on Alcohol Abuse and Alcoholism NIAAA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Evaluation for NIAAA Protocols
Status:
COMPLETED
Status Verified Date:
2015-12-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects 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
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 subjects 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
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 andor function in alcoholism
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 andor function in alcoholism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-AA-0009 | None | None | None |