Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Official Title: “Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging”

Background: - Functional and structural magnetic resonance imaging (MRI) techniques have allowed researchers to map and study how the brain works when at rest and when engaged in specific tasks. MRI scans have provided more information about how drugs affect the brain, and about how drug addiction changes the brain and influences behavior, mood, and thinking processes.

To better understand the underlying mechanism of drug addiction and to develop strategies for more effective treatment, researchers are interested in developing new MRI techniques to study the effects of addiction on the brain.

Objectives: - To develop new functional and structural MRI techniques, and to evaluate their potential use in brain imaging studies related to addiction.

Eligibility: - Individuals between 18 and 50 years of age. - Participants may be smokers or nonsmokers, and may use drugs or not use drugs.

Design: - During the initial screening, participants will complete questionnaires about family and personal history, drug use, and other information as required by the researchers.

Participants who will be asked to complete tasks during the MRI scan will be shown how to perform these tasks before the scanning session. - Before each study session, participants may be asked to complete some or all of the following: questions about their drug use during the last week, a breathalyzer test, a urine drug-use assessment, a urine pregnancy test, or a measure of carbon monoxide.

Participants will also provide blood samples before the start of the scan. - For each scanning session, participants will have an MRI scan that will last approximately 2 hours. - MRI scans may include injections with a contrast agent to study brain function, specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide.

Objective:

Functional and structural magnetic resonance imaging techniques have proven essential for noninvasive mapping of brain physiology and pathology. The primary objective of this protocol is to develop advanced magnetic resonance imaging and spectroscopy (MRI and MRS) techniques for neuroimaging studies related to addiction. These neuroimaging techniques will be used in other studies to better understand the underlying mechanism of drug addiction and to potentially develop strategies for more effective treatment.

Study population:

Healthy controls and drug users will participate in the study. Technical developments of MRI/MRS will be performed on healthy controls, while the evaluation of the applicability of these techniques to addiction related neuroimaging studies will be performed using drug users and healthy controls.

Design:

Based on the fundamental principle of the biophysical transduction of physiological signals to magnetic resonance (MR) imaging and spectroscopic signals, advanced techniques will be developed to measure the activity, metabolism, structure, and biochemistry of the brain. The development of these techniques typically includes the following steps: 1) proof-of-concept computer simulations, 2) implementation of the imaging concept with an MRI scanner and phantoms, 3) feasibility testing on control subjects, and 4) evaluation of the sensitivity and specificity of these techniques in detecting functional and/or structural alterations of the brain related to a specific disease.

Outcome measures:

Advanced neuroimaging techniques developed from this protocol will demonstrate the ability to distinguish between drug using and control populations. Successful techniques will then be incorporated into hypothesis driven studies in the Neuroimaging Research Branch at NIDA-IRP. These techniques will also be useful, through publications and technology transfer, to the entire neuroimaging society.

INCLUSION CRITERIA:

General:

• Male and non-pregnant female adults between the ages of 18-50.
• All subjects must be able to provide informed consent.

EXCLUSION CRITERIA:

Subjects will be excluded if they:

• Are pregnant. Urine pregnancy tests will be performed on all female volunteers of child-bearing potential before each experimental session.
• Are unable to undergo MRI scanning due to implanted metallic devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts including Copper 7 IUD) or claustrophobia.
• Have major medical illnesses to include, but not limited to, hypertension, cardiovascular disease, asthma, diabetes, peripheral vascular diseases, coagulopathies, syncope, history of superficial or deep vein thrombosis, HIV, or other clinically significant infectious diseases that may alter the signal being measured.
• Have current major psychiatric disorders to include, but not limited to, mood, anxiety, psychotic disorders.
• Have neurological illnesses including, but not limited to, seizure disorders, migraine, multiple sclerosis, movement disorders, or history of head trauma, CVA, CNS tumor.
• Have cognitive impairment as assessed by screening WASI vocabulary subtest below 48, corresponding to full IQ of 85 (in that case on screening, a full WASI will be done to verify IQ of 85 or above). Justification: Cognitive impairment and learning disabilities are associated with alterations in brain regions used to accomplish tasks, and, therefore, may introduce significant variably into the data.
• Inability to comply with task demands.

Additional exclusions for some experiments:

• Based on the scientific and medical requirements of the particular experiment, participants may also be excluded for:
• left-handedness (if using a cognitive or affective task),
• color-blindness (if using a task requiring color discrimination),
• drug use diagnosis (if a technique is being validated in a non-drug using population),
• renal insufficiency (if contrast agents are to be used), as determined by estimated glomerular filtration rate, which must be > 60 ml/min, as renal insufficiency greatly increases the risk of nephrogenic systemic fibrosis from gadolinium exposure.
• Renal insufficiency may also be associated with metabolic abnormalities that may interfere with MR imaging.
• Lactation (if contrast agents are to be used). The safety of gadolinium for nursing infants has not been established.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: National Institute on Drug Abuse (NIDA) NIH

Overall Clinical Trial Officials and Contacts

Overall Contact: MMG Recruiting (800) 535-8254 researchstudies@mail.nih.gov

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01036581

Study ID Number: 999903380

ClinicalTrials.gov Identifier: NCT01036581

Health Authority: United States: Federal Government