Characterization Imaging Instruments in Alcoholics and Non-Alcoholics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older,
Have been pre-screened, determined eligible for any NIAAA study, or enrolled in any
Disqualifiers
Positive BrAC#,
Positive urine drug test (UDT) # for benzodiazepines, cocaine, methamphetamines, and opiates for outpatients. Positive UDT for benzodiazepines is 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),
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Inpatient AUD
Group B: Outpatient
Trial outcomes
Primary outcomes
1
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 sessions2
Addiction Neuroimaging Assessments
structural and functional connectivity in salience, default mode, and executive control networks
Time frame
Multiple sessionsSecondary outcomes
1
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
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Source ClinicalTrials.gov