Behavioral and Functional Task Development, Implementation, and Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
between 18-65 years of age. The PI or designated AI will determine if any of the
Disqualifiers
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
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;
Trial design
Design model
Parallel
Treatments tested in this trial
7T MRI
DeviceModifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: 1Experimental treatment 1 intervention
Group B: 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
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Source ClinicalTrials.gov