Behavioral and Functional Task Development, Implementation, and Testing

Alcohol Use Disorder Clinical Trial

Official title:

Behavioral and Functional Task Development, Implementation, and Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108054
• Other study ID #: 140066
• Secondary ID: 14-AA-0066
• Status: Recruiting
• Phase: N/A
• Start date: May 28, 2014
• Est. completion date: December 31, 2025

Study information

• Verified date: November 8, 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Beth A Lee, R.N.
• Phone: (301) 451-6964
• Email: beth.lee[@]nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Addiction
• Alcohol Dependence
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   NIH Clinical Center Detailed Web Page