Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study ID
NCT02535702
Status
Recruiting
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Conditions

  • Normal Physiology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • In vivo MRS — OTHER
    1H MR spectroscopy to assess brain metabolites.
  • fMRI — OTHER
    Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.
  • EEG/EOG — OTHER
    Electroencephalography or electrooculography (EEG/ EOG) sessions to record electrical activity of the brain or measure corneo-retinal standing potentials.
  • Stimulation tasks — OTHER
    To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.
  • NSPRD — OTHER
    To be used in conjunction with pupillometry in the context of fMRI to study blood-oxygenation-level-dependent responses to selective neurostimulation of pain fibers.
  • Structural MRI — OTHER
    High spatial MRI and diffusion tensor imaging (DTI) to assess brain morphology and structural connectivity.

Study Details

Background: Abusing alcohol, drugs, and other substances can cause serious health problems. These substances also can affect brain function. Researchers want to learn more about brain function by using magnetic resonance imaging (MRI). This uses a magnetic field and radio waves to take pictures of the brain. Objective: To develop new ways to use MRI to study the brain. Eligibility: Healthy people 18 years of age or older. Design: 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. They will be asked about family history of alcoholism or drug abuse. Participants will answer questions to see if they can participate in MRI. Participants will have MRI scans. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the cylinder. A device called a coil may be placed over the head. Each sub-study will include up to 3 different MRI visits. Participants can be in multiple sub-studies. But they can have only 1 MRI per week and 20 per year. During MRI visits, participants may have urine collected. They may get another MRI questionnaire. Participants may have a clinical MRI brain scan. This may show physical problems in the brain. During some scans, participants may perform simple movement, memory, and thinking tasks. Participants may be connected to a machine to monitor brain activity during the scan. Small metal electrodes will be placed on the scalp. A gel will be placed in the space between the electrodes and the scalp.

Key Dates

Start date
Jun 28, 2016
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
192 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Attentional Bias Task
    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.
  • Experimental: Cue Reactivity Task
    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.
  • Experimental: Delay Discounting Task
    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
  • Experimental: Motivational Reward Task
    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.
  • Experimental: NSPRD Task
    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.
  • Experimental: Reasoning Task
    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.
  • Experimental: Respiratory Challenge (RC) Task
    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).
  • Experimental: Self-control Task
    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.
  • Experimental: Spinner Task and MID Task (monetary incentive delay task)
    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.

Primary Outcome Measure

The primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals. [ Time Frame: end of study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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