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Neuroimaging Techniques Development Related to Addiction

N/A

Recruiting

Led By Dardo G Tomasi, Ph.D.

Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eighteen years or older.

Eighteen years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study

Awards & highlights

Study Summary

This trial is looking for healthy people to develop new ways to use MRI to study the brain. Eligible participants will be screened with a medical history, physical exam, and blood and urine tests. They will answer questions about their drug use and psychiatric history.

Who is the study for?

This trial is for healthy adults over 18 who can consent to the study, understand English, and agree not to use drugs on test days. It's not for pregnant women, those over 550 lbs, people with certain metal objects in their body or claustrophobia, anyone with serious psychiatric disorders or neurological conditions like MS or Parkinson's Disease.Check my eligibility

What is being tested?

The study aims to develop new MRI techniques to better understand brain function related to addiction. Participants will undergo various types of MRI scans while performing simple tasks and may be involved in multiple sub-studies but limited to one MRI per week and twenty per year.See study design

What are the potential side effects?

MRI scans are generally safe but may cause discomfort due to loud noises during the scan or lying still for a long time. Some might feel anxious in the enclosed space of the scanner (claustrophobia). The electrodes used could cause mild skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The will be amplitude and reliability of regional-specific BOLD fMRI signals.

Secondary outcome measures

Collection of autonomic data

Trial Design

9Treatment groups

Experimental Treatment

Group I: Spinner Task and MID Task (monetary incentive delay task)Experimental Treatment3 Interventions

The Spinner task requires the subject to participate in a game of chance while lying in the MRI scanner. Subjects will be asked to respond by pressing a button. The MID task is a reaction time task. The MID Task tests how quickly a subject can press a button to hit a target on the screen in front of them. If the subject presses the button as soon as the target appears, the subject will score points. Subjects should try to score as many points as you can.

Group II: Self-control TaskExperimental Treatment4 Interventions

During the MRI scan, subjects will do a task that requires close concentration. Subjects will be asked to respond quickly to images on the computer screen, during which they will hear distracting noises. The subject will be able to remove the distraction in order to complete the task. During some sub-study sessions, subjects will start with no money ($0) and may be able to earn up to $40 if they do not remove the distraction. At other sub-study sessions, subjects will start with $40 and may lose between 25 to $1 each time they remove the distraction. Subjects cannot lose more than $40 in these sessions. Compensation for this sub-study is up to $40 per session, depending on their performance.

Group III: Respiratory Challenge (RC) TaskExperimental Treatment4 Interventions

Participants will be visually instructed to take a brief deep breath (inhale) and release the breath (exhale). They will inhale and exhale one more time with visual cues at specific times (60 seconds, 120 seconds, 180 seconds, 240 seconds, etc. with successive 60 seconds intervals). A black cross will remain centered on a grey slide during the normal respiration periods. To signal the RC periods, the slide will change color to yellow READY slide, then to green BREATHE IN slide, then to blue BREATHE OUT slide. The sequence will repeat one more time to Breath In and Breath Out and then finally go back to the yellow Breathe Normally slide. The instruction words will be written on the slides. Each slide will be shown for 3 seconds. The task will take a total of 15 minutes (total of 900 seconds with 14 RC periods).

Group IV: Reasoning TaskExperimental Treatment3 Interventions

Subjects will identify changes in various shapes when they are displayed on the screen in front of them. Some changes of the shapes may be that they were rotated, enlarged, or multiplied. Subjects will choose the changes in the shapes by pressing a button.

Group V: NSPRD TaskExperimental Treatment4 Interventions

During the MRI scan, subjects will get small electric shocks through electrodes placed on one of their toes. The shocks feel like an elastic band snapping against the skin. Right after a shock, subjects will see a dot on the computer screen. Subejcts will press a button to rate the intensity of the shock.

Group VI: Motivational Reward TaskExperimental Treatment4 Interventions

Subjects will make a choice among some items presented on the screen in front of them. One of the items will be the winner item. The other items will be loser items. Each time a subject is presented with various items, they will choose the item they think is the winner item. Subjects will start with bonus points at the beginning of the task, so they can add more points to this amount as they continue to choose winner items.

Group VII: Delay Discounting TaskExperimental Treatment3 Interventions

Subjects will be asked to imagine whether they would receive money now or money later (in the future). The future money option may be several days from now or as far out as 6 weeks from now. For example, a s ubject may see a $100 option in 6 weeks or a $10 option now. Subjects will not receive actual money for participation in this task

Group VIII: Cue Reactivity TaskExperimental Treatment3 Interventions

In this task subjects will view pictures of various items on the screen in front of them. Subjects will rate the items by how much they would like to have them. Subjects will choose how much they want the item by pressing a button.

Group IX: Attentional Bias TaskExperimental Treatment3 Interventions

Subjects will briefly see two images side by side on a screen. Immediately after, a dot appears on the left or on the right. The subjects task is to press the left or right button, following the position of the image (left or right). Images can contain food-related items. We will also show short 1-minute food-related movies. Subjects will be asked to fast for three hours before this task begins.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

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

800 Previous Clinical Trials

1,362,805 Total Patients Enrolled

5 Trials studying Normal Physiology

1,859 Patients Enrolled for Normal Physiology

Dardo G Tomasi, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

2 Previous Clinical Trials

137 Total Patients Enrolled

2 Trials studying Normal Physiology

137 Patients Enrolled for Normal Physiology

Media Library

fMRI Clinical Trial Eligibility Overview. Trial Name: NCT02535702 — N/A

fMRI 2023 Treatment Timeline for Medical Study. Trial Name: NCT02535702 — N/A

Normal Physiology Research Study Groups: Self-control Task, Reasoning Task, Attentional Bias Task, NSPRD Task, Delay Discounting Task, Cue Reactivity Task, Motivational Reward Task, Respiratory Challenge (RC) Task, Spinner Task and MID Task (monetary incentive delay task)

Normal Physiology Clinical Trial 2023: fMRI Highlights & Side Effects. Trial Name: NCT02535702 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being monitored in this clinical trial?

"Affirmative. Clinicaltrials.gov data indicate that this clinical trial, which was initially uploaded on June 28th 2016 is currently recruiting patients. 360 candidates must be found between two different sites for the study to continue uninterruptedly."

Answered by AI

Are there any vacancies left for individuals to partake in this experiment?

"According to the clinicaltrials.gov database, this trial is still open for enrollment; it was initially posted on June 28th 2016 and last edited on November 19th 2022."

Answered by AI