Neuroimaging Techniques Development Related to Addiction

Recruiting at 1 trial location

Overseen By Dardo G Tomasi, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must not be taking: Antidepressants, Stimulants

Disqualifiers: Pregnancy, Psychiatric disorders, Neurological disorders, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop better MRI techniques to understand brain function, particularly in relation to addiction. Participants will undergo MRI scans and engage in various tasks to explore brain activity and responses. It is suitable for healthy individuals over 18 who can commit to avoiding drug use on testing days. The study includes multiple sub-studies, each with different tasks, to gather comprehensive data on brain responses. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance understanding of brain function and addiction.

Will I have to stop taking my current medications?

The trial requires that you do not take any psychoactive drugs (medications that affect your mind, emotions, or behavior) like Celexa, Prozac, Wellbutrin, Zoloft, or stimulants like Adderall, Dexedrine, and Ritalin. If you are taking these medications, you would need to stop before participating.

What prior data suggests that these neuroimaging techniques are safe for studying brain function?

Research has shown that brain imaging techniques like MRI, EEG, and fMRI are generally safe for people. For instance, studies have found that EEG and fMRI can be used together without causing the body to overheat, maintaining a normal temperature during simultaneous tests.

MRI is a noninvasive method, meaning it doesn't involve surgery or injections. It uses magnets to capture images of the brain, providing a safe way to study brain function without radiation.

In vivo MRS measures chemicals in the brain and is designed to be safe, focusing on brain health without introducing risk.

Overall, these imaging methods, including structural MRI, are well-tolerated. They have been used in many studies without major safety concerns, making them a reliable way to study the brain while ensuring safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to develop advanced neuroimaging techniques that could revolutionize how we understand addiction. Unlike traditional methods, this trial uses a combination of sophisticated tools like fMRI, EEG, and structural MRI to get a detailed picture of brain activity and structure in response to different tasks. These tasks, such as the Self-control Task and Delay Discounting Task, are designed to probe specific cognitive functions related to addiction, potentially revealing new insights into how addictive behaviors are formed and maintained. By integrating these diverse imaging and task-based approaches, the study hopes to uncover patterns and mechanisms that could lead to more effective interventions for addiction in the future.

What evidence suggests that these neuroimaging techniques are effective for studying brain function related to addiction?

This trial will explore various neuroimaging techniques to understand addiction. Research has shown that brain scanning techniques like EEG, fMRI, and MRS enhance understanding of addiction. EEG highlights differences in brain activity between individuals with addiction and those without, and studies suggest it can also assist in treating addiction symptoms. fMRI reveals how addiction affects brain function, particularly in response to rewards. MRS provides insight into changes in brain chemistry caused by substance use. Structural MRI demonstrates how addiction can alter brain structure, impacting areas related to memory and motivation. Together, these tools help researchers better understand addiction and guide treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Dardo G Tomasi, Ph.D.

Principal Investigator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are willing to abstain from drug use on scheduled testing days.

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

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

I have not binge drunk every month for the last 10 years.

I am currently taking prescribed mental health or stimulant medications, but not for sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

MRI Visits

Participants undergo MRI scans to assess brain function, with tasks performed during scans

Varies per sub-study

Up to 3 visits per sub-study

Follow-up

Participants are monitored for safety and effectiveness after MRI sessions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EEG/EOG
• fMRI
• In vivo MRS
• NSPRD
• sMRI
• Stimulation tasks
• Structural MRI

Trial Overview

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.

How Is the Trial Designed?

Group I: Spinner Task and MID Task (monetary incentive delay task) Experimental Treatment 3 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 Task Experimental Treatment 4 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) Task Experimental Treatment 4 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 Task Experimental Treatment 3 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 Task Experimental Treatment 4 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 Task Experimental Treatment 4 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 Task Experimental Treatment 3 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 Task Experimental Treatment 3 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 Task Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Lead Sponsor

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Functional neuroimaging techniques like fMRI and 1H-MRS reveal distinct brain activation patterns in drug abusers, which can vary based on the type of drug, the specific task, and the individual's gender.

1H-MRS findings indicate that drug abusers, particularly those dependent on cigarettes, cocaine, and alcohol, typically show lower levels of N-acetylaspartate and higher levels of creatine in their brains, suggesting metabolic changes associated with addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance and spectroscopy in drug and substance abuse. Magalhaes, AC.[2019]

Magnetic resonance imaging (MRI) and spectroscopy are effective tools for detecting brain anatomical changes linked to substance abuse, including alcohol, stimulants, and narcotics.

Functional MRI and spectroscopy can identify subtle biochemical and functional changes in the brain, providing insights into the mechanisms of drug reinforcement and the effects of substance abuse on living tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Studies of Substance Abuse. Kaufman, MJ., Levin, JM., Christensen, JD., et al.[2019]

Neuroimaging techniques, such as SPECT, PET, fMRI, and MRS, have significantly enhanced our understanding of the brain changes associated with substance abuse disorders, moving beyond just structural imaging to explore functional aspects.

These techniques have not only helped characterize the pharmacology of abused substances but also revealed important insights into the neuropsychiatric mechanisms underlying substance abuse, including changes in cerebral metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuroimaging in substance abuse disorders]. de Mendelssohn, A., Kasper, S., Tauscher, J.[2019]

MRI has been instrumental in addiction research, revealing disturbances in frontostriatal circuitry that are linked to cognitive functions predicting drug relapse and treatment responses.

Future advancements in MRI technology, such as increased field strength, promise to enhance image quality and deepen our understanding of brain structure and function in relation to addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neurobiology of addiction: the perspective from magnetic resonance imaging present and future. Suckling, J., Nestor, LJ.[2022]

The study introduces a real-time MRI technique that allows for continuous monitoring of MRI signals during pharmacological experiments, which is crucial for accurately assessing drug effects in anesthetized animals.

This method was successfully applied in manganese-enhanced MRI (MEMRI) to evaluate blood-brain barrier disruption before cocaine administration, enhancing the reliability of the experimental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time animal functional magnetic resonance imaging and its application to neuropharmacological studies. Lu, H., Yang, S., Zuo, Y., et al.[2021]

Non-invasive neuroimaging techniques like fMRI and MRS are becoming essential tools in psychiatry and drug development, helping to identify brain regions involved in various functions and monitor treatment responses.

These methods not only aid in understanding brain chemistry and function but also hold promise for discovering new drug targets and biomarkers, bridging the gap between preclinical research and clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of non-invasive neuroradiological methods in research of psychoactive drugs. Henigsberg, N., Kovacić, Z., Kalember, P.[2007]

Functional magnetic resonance imaging (fMRI) and spectroscopy (MRS) are powerful techniques for studying brain activity and function, as demonstrated in studies involving both control subjects and Parkinsonian patients.

These imaging methods can be applied to investigate the effects of various pharmacological agents, including drugs of abuse, providing insights into their neural mechanisms and potential impacts on brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging and magnetic resonance spectroscopy assessment of brain function in experimental animals and man. Morris, PG.[2017]

Modern imaging techniques allow researchers to visualize the effects of drugs on the brain in real-time, providing insights into the neurobiological mechanisms of drug abuse and addiction.

The article discusses five commonly used imaging methods, highlighting their contributions to understanding addiction and potential clinical applications for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging the addicted human brain. Fowler, JS., Volkow, ND., Kassed, CA., et al.[2019]

Cocaine administration in conscious rats led to a significant increase in brain activation, as measured by BOLD signal intensity, particularly in areas associated with reward and motivation, such as the substantia nigra and nucleus accumbens.

The study successfully demonstrated that fMRI can be used to assess the effects of cocaine on brain activity without causing significant cardiovascular or respiratory issues, highlighting a new method for studying psychostimulant effects in live subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging cocaine-induced changes in the mesocorticolimbic dopaminergic system of conscious rats. Febo, M., Segarra, AC., Tenney, JR., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9619053/

A scoping review of electroencephalographic (EEG) markers ...

The main findings are that odd ball P3 and resting beta have strong evidence as useful potential biomarkers of SUD treatment outcomes.

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/add.70164

Effect of EEG neurofeedback therapy on addiction disorders

EEG-NF statistically significantly alleviated addiction symptoms (Hedges'g = 0.85, P < 0.001), with stronger effects on substance addiction than ...

3.

journals.lww.com

journals.lww.com/jnsm/fulltext/9900/electroencephalography_based_emotional_analysis.22.aspx

Electroencephalography-based Emotional Analysis Using...

Conclusions: The findings suggest that EEG is effective in detecting neurological differences between healthy and drug-addicted individuals.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178125001222

A systematic review on the role of EEG and fMRI ...

EEG/fMRI-neurofeedback can improve addictive symptoms especially craving. EEG/fMRI-neurofeedback can be promising add-on therapies for substance use disorders.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2259255/

EEG Biofeedback as a Treatment for Substance Use Disorders

The findings of studies on the effects of alcohol dependence on EEG coherence can be summarized as follows: Kaplan et al. (1985) reported lower frontal alpha ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8253410/

Safety and data quality of EEG recorded simultaneously ...

This observation indicates that simultaneous EEG-fMRI recordings using this MB sequence can be safe in terms of RF-related heating, and that EEG data recorded ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3462350/

Neuroimaging for drug addiction and related behaviors - PMC

In this review, we highlight the role of neuroimaging techniques in studying the emotional and cognitive-behavioral components of the addiction syndrome.

8.

journals.plos.org

journals.plos.org/plosone/article?id=10.1371/journal.pone.0238485

Safety and data quality of EEG recorded simultaneously with ...

This observation indicates that simultaneous EEG-fMRI recordings using this MB sequence can be safe in terms of RF-related heating, and that EEG data recorded ...

9.

ideals.illinois.edu

ideals.illinois.edu/items/118447/bitstreams/388877/data.pdf

safety and data quality of eeg recorded simultaneously with

This observation indicates that simultaneous EEG-fMRI recordings using this MB sequence can be safe in terms of RF-related heating, and that EEG data recorded ...

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1056871916300119

EEG in non-clinical drug safety assessments

In the current paper, we discuss the various aspects of preclinical EEG to characterize drug-induced seizure risk and sleep disturbances, as well as describe ...