Behavioral and Functional Task Development, Implementation, and Testing

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.

Study Overview

• Status: Recruiting
• Conditions: Alcohol Drinking; Alcohol Dependence; Alcoholism; Addiction; Alcohol Use Disorder
• Intervention / Treatment: Device: 7T MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Reza Momenan, Ph.D.; Phone Number: (301) 451-6972; Email: rezam@nih.gov
• Study Contact Backup: Name: Beth A Lee, R.N.; Phone Number: (301) 451-6964; Email: beth.lee@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

• INCLUSION CRITERIA:
• between 18-65 years of age.

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).

-MRI Exclusion Criteria:

• 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 positive pregnancy test
• Left handed
• Claustrophobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; People with alcohol use disorder	Device: 7T MRI; Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation
Experimental: 2; People without alcohol use disorder	Device: 7T MRI; Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Reza Momenan, Ph.D., National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2014
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimated): April 9, 2014

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: November 8, 2023

More Information

Terms related to this study

• Keywords: Imaging; fMRI; EEG; Alcoholism; Phenotype; Psychophysiology; Near Infrared
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 140066; 14-AA-0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .This study is designed to determine and modify tasks to induce and affect various behavioral, psychophysiological and neural responses. Therefore, it appears that in order to make such data available they should be collected in future hypothesis driven studies that utilize the tasks developed under this protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No