Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

About this trial

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.

...

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • In vivo MRS

    Other intervention

    1H MR spectroscopy to assess brain metabolites.

  • fMRI

    Other intervention

    Three fMRI sessions to assess test-retest reliability of functional connectivity (FC) measures at rest and during task performance.

  • EEG/EOG

    Other intervention

    Electroencephalography or electrooculography (EEG/ EOG) sessions to record electrical activity of the brain or measure corneo-retinal standing potentials.

  • Stimulation tasks

    Other intervention

    To be used in the context of fMRI to study blood-oxygenation-level- dependent responses in the brain to sensory stimulation.

  • NSPRD

    Other intervention

    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 intervention

    High spatial MRI and diffusion tensor imaging (DTI) to assess brain morphology and structural connectivity.

Treatment groups

192 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Attentional Bias TaskExperimental treatment 3 interventions
Group B: Cue Reactivity TaskExperimental treatment 3 interventions
Group C: Delay Discounting TaskExperimental treatment 3 interventions
Group D: Motivational Reward TaskExperimental treatment 4 interventions
Group E: NSPRD TaskExperimental treatment 3 interventions
Group F: Reasoning TaskExperimental treatment 3 interventions
Group G: Respiratory Challenge (RC) TaskExperimental treatment 4 interventions
Group H: Self-control TaskExperimental treatment 3 interventions
Group I: Spinner Task and MID Task (monetary incentive delay task)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
end of study
2

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

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).

Time frame
end of study
3

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

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).

Time frame
end of study

Secondary outcomes

1

Collection of autonomic data

Autonomic data may be collected or observations made during the course of the experiment that will give further information about the state of the body and emotions during experiments (blood pressure, skin conductance, respiratory rate). Self-report data may be collected during the course of the experiment to assess the level of interest, boredom, alertness of the participants.

Time frame
end of study

Other outcomes

Sponsors and contacts

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