Development of Neuroimaging Methods to Assess the Neurobiology of Addiction
-
- STATUS
- Recruiting
-
- End date
- Dec 31, 2026
-
- participants needed
- 360
-
- sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 Identifier | NCT02535702 |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Last Modified on | 25 October 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer