Behavioral and Functional Task Development, Implementation, and Testing
Primary Purpose
Alcohol Dependence, Alcohol Drinking, Alcoholism
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7T MRI
Sponsored by
About this trial
This is an interventional other trial for Alcohol Dependence focused on measuring fMRI, Alcoholism, Phenotype, Imaging, EEG, Psychophysiology, Near Infrared
Eligibility Criteria
- 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.
Sites / Locations
- National Institutes of Health Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
People with alcohol use disorder
People without alcohol use disorder
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02108054
First Posted
April 8, 2014
Last Updated
September 28, 2023
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02108054
Brief Title
Behavioral and Functional Task Development, Implementation, and Testing
Official Title
Behavioral and Functional Task Development, Implementation, and Testing
Study Type
Interventional
2. Study Status
Record Verification Date
September 26, 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2014 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Drinking, Alcoholism, Alcohol Use Disorder, Addiction
Keywords
fMRI, Alcoholism, Phenotype, Imaging, EEG, Psychophysiology, Near Infrared
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
People with alcohol use disorder
Arm Title
2
Arm Type
Experimental
Arm Description
People without alcohol use disorder
Intervention Type
Device
Intervention Name(s)
7T MRI
Intervention Description
Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation
Primary Outcome Measure Information:
Title
outcome is to develop and examine tasks that reliably measure specific cognitive, motivational and decision-making behaviors
Description
Tasks that are suitable for fMRI studies and other clinical research measurements
Time Frame
ONGOING
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beth A Lee, R.N.
Phone
(301) 451-6964
Email
beth.lee@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Reza Momenan, Ph.D.
Phone
(301) 451-6972
Email
rezam@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Momenan, Ph.D.
Organizational Affiliation
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY dial 711
Email
ccopr@nih.gov
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2014-AA-0066.html
Description
NIH Clinical Center Detailed Web Page
Learn more about this trial
Behavioral and Functional Task Development, Implementation, and Testing
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