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Behavioral and Functional Task Development, Implementation, and Testing

Behavioral and Functional Task Development, Implementation, and Testing

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108054
Enrollment
400
Registered
2014-04-09
Start date
2014-05-28
Completion date
2026-12-31
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence, Alcohol Drinking, Alcoholism, Alcohol Use Disorder, Addiction

Keywords

fMRI, Alcoholism, Phenotype, Imaging, EEG, Psychophysiology, Near Infrared

Brief summary

Background: \- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies. Objective: \- To develop tasks that investigate a person s behavior that can be used in later studies. Eligibility: * Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old. * Healthy right-handed volunteers 18-65 years old. Design: * Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview. * Participants will have between one and three visits. * Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder. * Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it. * The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.

Detailed description

Objective: The purpose of this protocol is three-fold: 1) to develop tasks examining various cognitive, motivational, and decision-making behaviors outside the scanner; 2) to modify, refine, and verify the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation; and 3) to examine equivalent or surrogate signals using other devices such as electroencephalograph (EEG) and functional near infrared spectrometer (fNIRS) when the MR contraindication(s) are present in the participant. Study population: Healthy volunteers without an alcohol use disorder, and inpatient participants with alcohol dependence as determined by the DSM-IV-TR or at least Moderate Alcohol Use Disorder as determined by DSM-5. Design: The participants will pilot one or both aspects of this study depending on whether the task is de novo or a modification to previously verified or published task. Outcome measures: The outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors and invoke associated brain systems and functions in our targeted subject populations.

Interventions

DEVICE7T MRI

Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: * between 18-65 years of age. The PI or designated AI will determine if any of the

Exclusion criteria

listed below applies\*.

Design outcomes

Primary

MeasureTime frameDescription
outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviorsONGOINGTasks that are suitable for fMRI studies and other clinical research measurements

Countries

United States

Contacts

CONTACTBeth A Lee, R.N.
beth.lee@nih.gov(301) 451-6964
CONTACTPaule V Joseph, C.R.N.P.
paule.joseph@nih.gov(301) 827-5234
PRINCIPAL_INVESTIGATORPaule V Joseph, C.R.N.P.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026