Behavioral and Functional Task Development, Implementation, and Testing

NCT ID: NCT02108054

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-28
• Study Completion Date: 2026-12-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

People with alcohol use disorder

Group Type: EXPERIMENTAL

7T MRI

Intervention Type: DEVICE

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

2

People without alcohol use disorder

Group Type: EXPERIMENTAL

7T MRI

Intervention Type: DEVICE

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

Interventions

7T MRI

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

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Beth A Lee, R.N.

Role: CONTACT

beth.lee@nih.gov

(301) 451-6964

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

Role: CONTACT

paule.joseph@nih.gov

(301) 827-5234

Facility Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Role: primary

ccopr@nih.gov

800-411-1222 ext. TTY dial 711

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-AA-0066.html

NIH Clinical Center Detailed Web Page

Other Identifiers

14-AA-0066

Identifier Type: -

Identifier Source: secondary_id

140066

Identifier Type: -

Identifier Source: org_study_id