Alcoholism Clinical Trial
Official title:
Characterization Imaging Instruments for Addiction Neuroimaging Assessments
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: - Participants will visit the NIH Clinical Center once during the study. - Participants will be screened with a medical history, EKG, and physical exam. They will give blood and urine samples and undergo a psychiatric interview. - Participants will be asked about their alcohol drinking, to see if they have an alcohol use disorder. - Participants will play three computerized games. Some will play these games inside a magnetic resonance imaging (MRI) scanner. - MRI: strong magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner for about 90 minutes. They may lie still for up to 20 minutes at a time. The scanner makes loud knocking noises. They will get earplugs.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | - INCLUSION CRITERIA: All adult participants must be: - Age 18 years or older, - Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any 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 at 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 Individuals with a positive breath alcohol concentration (BrAC), UDT, or pregnancy test will be rescheduled or withdrawn from the study.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* - Positive BrAC#, - Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, opiates and tetrahydrocannabinol (THC) for outpatients. Positive UDT for benzodiazepines and THC are not exclusionary for the inpatients. It is common that the inpatients who are treated for AUD withdrawal are treated with benzodiazepines. Positive THC would also not be exclusionary for this study since it tends to be detected over the long period of time after use. However, we will make note of these for the data analysis purposes. - Task performance (behavioral, fMRI) only: cleared based on neuromotor examination, - Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments), - Cannot lie comfortably flat on back for up to 2 hours in the MRI scanner, - Uncomfortable in enclosed spaces (has claustrophobia) such that they would feel discomfort in the scanner, - Women: are pregnant#, - Are left-handed. - 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. - Participants who meet this exclusion criterion will not participate in any part of this study at the time. They will be re-scheduled for a future date(s) when they do not meet any of the exclusionary criterion. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Andrews MM, Meda SA, Thomas AD, Potenza MN, Krystal JH, Worhunsky P, Stevens MC, O'Malley S, Book GA, Reynolds B, Pearlson GD. Individuals family history positive for alcoholism show functional magnetic resonance imaging differences in reward sensitivity that are related to impulsivity factors. Biol Psychiatry. 2011 Apr 1;69(7):675-83. doi: 10.1016/j.biopsych.2010.09.049. Epub 2010 Dec 3. — View Citation
Baker KG, Harding AJ, Halliday GM, Kril JJ, Harper CG. Neuronal loss in functional zones of the cerebellum of chronic alcoholics with and without Wernicke's encephalopathy. Neuroscience. 1999;91(2):429-38. doi: 10.1016/s0306-4522(98)90664-9. — View Citation
Bjork JM, Hommer DW, Grant SJ, Danube C. Impulsivity in abstinent alcohol-dependent patients: relation to control subjects and type 1-/type 2-like traits. Alcohol. 2004 Oct-Nov;34(2-3):133-50. doi: 10.1016/j.alcohol.2004.06.012. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Multiple sessions | |
Primary | Addiction Neuroimaging Assessments | structural and functional connectivity in salience, default mode, and executive control networks | Multiple sessions | |
Secondary | 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 | MRI STUDY VISIT |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
Completed |
NCT05877807 -
Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
|
||
Completed |
NCT00000437 -
Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)
|
Phase 4 | |
Completed |
NCT00536146 -
The Stress-Hormone System in Alcohol-Dependent Subjects
|
N/A | |
Terminated |
NCT00890149 -
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
|
Phase 2 | |
Completed |
NCT02939352 -
The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues
|
Early Phase 1 | |
Completed |
NCT02179749 -
Mifepristone Treatment of Alcohol Use Disorder
|
Phase 2 | |
Terminated |
NCT01408641 -
Topiramate for Alcohol Use in Posttraumatic Stress Disorder
|
N/A | |
Completed |
NCT01553136 -
Varenicline Treatment of Alcohol Dependence in Smokers
|
Phase 2 | |
Completed |
NCT01389297 -
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
|
N/A | |
Completed |
NCT01113164 -
Matching Genotypes and Serotonergic Medications for Alcoholism
|
Phase 1 | |
Completed |
NCT00768508 -
Combined Pharmacotherapies for Alcoholism
|
Phase 3 | |
Completed |
NCT01760785 -
Valproate for Mood Swings and Alcohol Use Following Head Injury
|
N/A | |
Terminated |
NCT02842528 -
Cognitive Vulnerability Factors in Alcohol-dependence
|
N/A | |
Completed |
NCT00127231 -
Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women
|
N/A | |
Completed |
NCT00367575 -
An Internet-based Intervention for Problem Drinking
|
N/A | |
Completed |
NCT00223639 -
New Medications to Treat Alcohol Dependence
|
Phase 2 | |
Completed |
NCT00583440 -
12-step Facilitation for the Dually Diagnosed
|
Phase 1/Phase 2 | |
Completed |
NCT00167687 -
Prazosin Alcohol Dependence IVR Study
|
Phase 4 |