Behavioral and Functional Task Development, Implementation, and Testing

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT02108054

Collaborator

(none)

400

Enrollment

Location

Arms

139.1

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence Alcohol Drinking Alcoholism Alcohol Use Disorder Addiction	Device: 7T MRI	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Behavioral and Functional Task Development, Implementation, and Testing

Actual Study Start Date :

May 28, 2014

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision making behaviors [ongoing]
Tasks that are suitable for fMRI studies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.