Behavioral and Functional Task Development, Implementation, and Testing

NCT02108054 | Recruiting

• 2 other identifiers: 14006614-AA-0066
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Dependence; Alcohol Drinking; Alcoholism; Alcohol Use Disorder; Addiction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors

  Tasks that are suitable for fMRI studies and other clinical research measurements

  ONGOING

Study Arms (2)

1

EXPERIMENTAL

People with alcohol use disorder

Device: 7T MRI

2

EXPERIMENTAL

People without alcohol use disorder

Device: 7T MRI

Interventions

7T MRI DEVICE

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Are not cleared on a neuromotor examination
• Are currently receiving psychotropic medication
• Inpatients only: Currently experiencing symptoms of withdrawal from alcohol (As determined by the most recent measurement within the
• past 30 days CIWA score \> 8).
• Presence of ferromagnetic objects in the body including implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metallic fragments in the eye that welders and other metal workers may have;
• Are pregnant, as determined by a negative pregnancy test
• Left handed
• Claustrophobia.
• To minimize discomfort and undue burden on the participants, unless available from phone screening, pre-screening, or other NIAAA studies such as 14-AA-0080, 14-AA-0181, we collect the above information as part of this study.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Alcoholism; Alcohol Drinking; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Drinking Behavior; Behavior; Compulsive Behavior; Impulsive Behavior

Study Officials

• Paule V Joseph, C.R.N.P.

  National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth A Lee, R.N.

CONTACT

(301) 451-6964; beth.lee@nih.gov

Paule V Joseph, C.R.N.P.

CONTACT

(301) 827-5234; paule.joseph@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 9, 2014
• Study Start: May 28, 2014
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2025-12-03

Locations

US (1)