Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    360
  • sponsor
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Updated on 28 July 2021

Summary

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.

Description

  • Objectives: There are two main goals in this protocol, 1) to improve sensitivity as well as spectral and spatiotemporal resolutions in magnetic resonance (MR) studies assessing structural, neurochemical, hemodynamic and electrophysiological changes that occur in the human brain during the resting state as well as those that occur in response to novel sensory, motor, cognitive or emotional stimulation paradigms; and 2) to conduct pilot sub-studies, which are exploratory in nature, in order to gather enough information for hypothesis generation. The criterion for transition to a new full protocol will be a sufficient amount of information to generate a power analysis.
    • Study population: We intend to complete studies in a healthy volunteers of 120 males and 120 females, 18 years or older.
    • Design: We will design small projects as ideas pertinent to the theme of Addiction and conduct pilot sub-studies, each with up to 16 subjects, to optimize MR pulse sequences and/or functional MR imaging (fMRI) task paradigms. MR pulse sequences and/or fMRI task paradigms will be validated against appropriated gold-standard methods/tasks. These studies are required in order to maximize the sensitivity of new imaging techniques and fMRI tasks used for clinical and research applications that take advantage of 3T and 7T MRI scanners in the MR center. If an exploratory sub-study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory sub-studies performed in the present protocol.
    • Outcome parameters: Although multiple measures will be collected, the primary outcome will be amplitude and reliability of regional-specific BOLD fMRI signals.
    • MRI: we will analyze measures such as the amplitude and the reliability of the test-retest measures of fMRI signals; functional connectivity metrics; tractography between seed and target regions of interest (diffusion tensor imaging, DTI); morphometry of brain regions (using automatic segmentation and voxel-brain morphometry, VBM); and brain metabolite levels in regions of interest (using MR spectroscopy, MRS).
    • EEG (electroencephalography): we will quantify measures such as event or task-related potentials, and coherence between sensors or sources located close to the brain areas of interest. We are also quantifying blink rates from the electrooculogram (EOG).
    • Behavioral measures during fMRI tasks: we will quantify measures such as reaction times and accuracy (using MRI compatible response pads) as well as eye movement (using MRI compatible eye trackers) and self-reports of the study experience (i.e. degree of interest and motivation and alertness).
    • We may measure autonomic data during the course of the fMRI experiment (such as blood pressure, skin conductance, respiratory frequency and heart rate), which would correlate to the outcome measures.

Details
Condition Normal Physiology
Treatment MRI, fMRI, Neurometer CPT/C, In vivo MRS, sMRI, EEG/EOG, Stimulation tasks, NSPRD
Clinical Study IdentifierNCT02535702
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Last Modified on28 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Eighteen years or older
Ability to provide written informed consent as determined by physical examination and verbal communication. Capacity to consent will be determined by those obtaining the informed consent
Willingness to abstain from drug use on scheduled testing days
EXCLUSION CRITERIA
Positive urine pregnancy test in females
Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (including but not limited to pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces as determined by the self-report checklist
Claustrophobia
Body weight >550 lbs, which is the weight limit of the MR scanner
Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder (other than nicotine/caffeine use disorders) as determined by history and clinical exam including substance use disorder, alcoholism and alcohol dependence. Past history of a mental disorder as defined by DSM-IV or DSM-5 will be excluded only if it was severe enough as to require hospitalization (any length), or chronic medication management (more than 4 weeks), or that could impact brain function at the time of the study. Subjects receiving psychotherapy may be included in the study
Those with a binge drinking history every month continuously for the last 10 years will also be excluded. Binge drinkers are those who being female consume 4 or more drinks and males consume 5 or more drinks in one occasion at least once a month
Serious neurological disorder such as MS, Parkinson s Disease, ALS, sensory loss or peripheral neuropathy
Currently taking any psychoactive drugs such as Celexa (TM), Prozac (TM), Wellbutrin (TM), Zoloft (TM), and/or stimulants other than caffeine such as Adderall (TM), Dexedrine (TM) and Ritalin (TM). Subjects taking PRN medications (e.g., sleep medications) may be included in the study
Clinically significant laboratory or examination results
Study investigators and staff, as well as their superiors, subordinates and immediate family members (adult children, spouses, parents, siblings)
Subjects will not be excluded from enrollment onto this study if their urine
test is positive for drugs. However, if they test positive on scheduled study
procedure days involving MRI, the procedures will be postponed and
rescheduled. We will allow for up to 3 rescheduled study days that were the
result of positive urine drug screens. If the drug test is positive on the
third rescheduled visit, the participant will be withdrawn from the study
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