Healthy Clinical Trial
Official title:
Screening Evaluation for NIAAA Protocols
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |