An observational study in Alcohol Dependence, Alcohol Drinking and Alcohol-Related Disorders, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Observational
Among 70 studies in Alcoholism by National Institute on Alcohol Abuse and Alcoholism (NIAAA) — 9 open to participants now, 9 under way, none of them phase 3. Alcoholism · National Institute on Alcohol Abuse and Alcoholism (NIAAA).
Among the 70 studies in Alcoholism by National Institute on Alcohol Abuse and Alcoholism (NIAAA), this one is the 8th largest by enrollment of the 17 observational ones, is one of 5 that started in 2014, is one of 15 observational ones, and was the 47th registered.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 389 is above the median of 159 across 183 observational studies indexed under Alcoholism.
Browse Alcoholism studies →9 of the 70 studies in Alcoholism by National Institute on Alcohol Abuse and Alcoholism (NIAAA) are open now, in 1 country. Each count lists the studies.
Of the 239 Alcoholism studies recruiting now, 84 (35%) set no upper age limit and 133 (56%) stop at 75 or younger; 11 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →70 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 5 started in 2014.
Median enrollment 100 across the 50 interventional studies, 98 across the 17 observational. Of the 57 that completed or were terminated, 19 (33%) have results posted.
National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 102 studies on the registry; 14 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 9 (69%) have results posted.
4 of the studies in Alcoholism by National Institute on Alcohol Abuse and Alcoholism (NIAAA) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06269627National Institute on Alcohol Abuse and Alcoholism (NIAAA)Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder | 2026-12-31 |
| NCT04391816National Institute on Alcohol Abuse and Alcoholism (NIAAA)COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study | 2026-12-31 |
| NCT07325266National Institute on Alcohol Abuse and Alcoholism (NIAAA)Human Laboratory Study of Apremilast for Alcohol Use Disorder | 2027-01-31 |
| NCT07046819National Institute on Alcohol Abuse and Alcoholism (NIAAA)Tirzepatide in MetALD | 2027-07-30 |
Among the 70 studies in Alcoholism by National Institute on Alcohol Abuse and Alcoholism (NIAAA), from their registry updates:
Background:
- People with alcoholism have differences in their brains compared with healthy people. People who are dependent on alcohol also perform differently on behavioral tasks. Researchers want to find out more about these differences. They also want to see if these differences are related to DNA.
Objective:
- To see if differences in brain structure relate to personality and behavior differences in people with and without alcohol dependence.
Eligibility:
- Adults age 18 and older.
Design:
Objective
The purpose of this protocol is to obtain a standard set of imaging assessments, referred to hereinafter as Characterization Imaging Instruments for Addiction Neuroimaging Assessments (CII-ANiA), including but not limited to brain behavioral, structural, functional, and connectivity (structural and functional) information, on all NIAAA research participants: a) to determine how individual differences in brain structure and function relate to various stages of alcohol use disorder, generalized trait personality, and behavior differences (as assessed by psychometric questionnaire instruments and behavioral measures); and b) to determine whether these individual differences relate specifically to genetic polymorphisms in genes governing neurotransmitter activity. Thus, our goal of the CII-ANiA is to identify the brain (structural and functional), behavioral, genetic, and other phenotypic factors that are associated with alcoholism.
Study population
Non-treatment seeking adult volunteers and inpatient participants with alcohol use disorder (AUDs). Inpatient AUDs refer to individuals diagnosed with alcohol dependence based on DSM-IV-RT criteria or Alcohol Use Disorder as determined by DSM-5 criteria.
Design
This study will require one or more visit(s) that will include MRI scan(s) (if the participant is determined eligible) consisting of a whole brain structural MRI, Diffusion Tensor MRI, Resting State functional MRI (rs-fMRI), several task-based functional MRIs, while performing computerized motivational, cognitive, and emotional tasks.
Outcome measures
Outcome measures of interest include differences in brain structural data and in blood oxygenation level dependent (BOLD) signals collected cross-sectionally and/or longitudinally at various stages of alcohol use disorder. Imaging outcomes will be measured with standard techniques and analyzed using established image analysis approaches and software tools such as AFNI, SPM, FSL, DTI Studio, etc. In this effort, we will also utilize BOLD signals elicited by each task which have been shown to be associated with various aspects of neurocircuitries in the phases of addiction. To this end, the outcome measures of interest will include, but will not be not limited to, BOLD signals for the binge/intoxication phase in the nucleus accumbens, thalamus and dorsolateral prefrontal cortex; for the withdrawal/negative emotionality phase in the amygdala, hippocampus, and ventral striatum; and for the preoccupation/anticipation phase in the prefrontal cortex, ventral striatum, and insula. Other primary outcome measures include structural and functional connectivity in salience, default mode, and executive control networks associated with the above-mentioned addiction phases, respectively. Secondary outcome measures include comparisons of the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols.
The study population will consist of outpatient and inpatient participants who are 18 years of age or older who are eligible for or enrolled in other NIAAA protocols. The participant s AUD status at the time of this study will be evaluated as part of the screening procedures of the NIAAA screening protocol 14-AA-0181. The participant s status will be determined using either the DSM-IV-TR or the DSM-5, which also classifies present AUD as mild, moderate, or severe.
All adult participants must be:
NIAAA study (including 14-AA-0181).
EXCLUSION CRITERIA:
As this is a natural history protocol, there are no exclusionary criteria for this study.
Participants should have been tested negative prior to the time of consent and study procedures using an alcohol breathalyzer, urine drug (UDT) and, when applicable, pregnancy tests. Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be re-scheduled or withdrawn from the study.
Upon completion of the consent, the participant will be invited for the study session. On the study session day, the following exclusion criteria will be applied.
-Exclusion criteria for MR scan*
Inpatient participants with alcohol use disorder who have symptoms of alcohol withdrawal as indicated by the most recent measurement within the past 30 days, measured by the Clinical Institute Withdrawal Assessment (CIWA-Ar) score > 8.
Subjects excluded from MR scan may still perform the behavioral tasks which would otherwise be performed in the scanner, if they qualify for behavioral tasks. To avoid undue discomfort, burden, and inconvenience this information, if available, can be gathered from routine clinical care or other NIAAA clinical studies and data.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes individuals who are in the alcohol use treatment.
This group includes individuals who are not seeking treatment for alcohol use disorder.
Addiction Neuroimaging Assessments & blood oxygenation level
Outcome measures of interest include differences in brain structural data and in blood oxygenation level dependent (BOLD) signals collected cross-sectionally and /or longitudinally at various stages of alcohol use disorder
Time frame: Multiple sessions
Addiction Neuroimaging Assessments
structural and functional connectivity in salience, default mode, and executive control networks
Time frame: Multiple sessions
AFNI, FSL, SPM and FreeSurfer software
Secondary outcome measures are to compare the genetic, behavioral and phenotypic factors to imaging and behavioral data acquired across other protocols
Time frame: MRI STUDY VISIT
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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