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Protocol Details

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute on Drug Abuse (NIDA)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 80 Years

Referral Letter Required


Population Exclusion(s)

Adults who are or may become unable to consent;
Pregnant Women;
Non-English Speaking


Magnetic Resonance Imaging (MRI);
Functional Brain Imaging;
Magnetic Resonance Spectroscopy;
Diffusion Tensor Imaging;
Drug Abuse

Recruitment Keyword(s)



Drug Abuse;
Nicotine Dependence

Investigational Drug(s)


Investigational Device(s)



Device: MagPro X100 Magnetic Stimulator
Device: Transcranial Rotating Magnetic Stimulator
Device: Magnetom Prisma Fit 3T Scanner

Supporting Site

National Institute on Drug Abuse


- 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.


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


- Individuals between 18 and 80 years of age.

- Participants may be smokers or nonsmokers, and may use drugs or not use drugs.


- 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 specific tasks to be performed during the scan, or an experiment that studies the brain's response to carbon dioxide.

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Subjects must be between the ages of 18-80, be generally healthy and male or non-pregnant female. Smokers, non-smokers, drug using and non-drug using populations will participate in this study.



-Male and non-pregnant female adults between the ages of 18-80.

-All subjects must be able to provide informed consent.


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.

-Are non-English speaking. Justification: There is no direct benefit to participants in this study, and some of the study procedures involve more than minimal risk. To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI and TMS/TRPMS procedures. The inability to effectively communicate MRI and TMS/TRPMS safety procedures could compromise the safety of non-English speaking participants.

-Suspected or confirmed active SARS-CoV-2 infection. Assessment tool: 2019 Novel Coronavirus (COVID-19) patient screening tool administered by phone prior to participant arrival. The current version of the screening tool to be used is available at Viral testing looking for SARS-CoV-2 in a specimen deemed appropriate by NIH (such as nasopharyngeal or mid-turbinate swab) may also be completed. We reserve the right to change the specimen type as NIH approves new test procedures. This test may be carried out in-house at NIDA, NIH, at a community testing site or through a commercial vendor. Anyone with a positive symptom screen without a clear alternative explanation or a positive viral test will be excluded until they recover or (for asymptomatic cases) are no longer infectious. MAI will also retain the ability to exclude for a suspicious symptom screen without positive viral test. Justification: COVID-19 is extremely infectious and can have serious consequences. Allowing participants with active infection would alter the risk:benefit ratio for non-treatment studies without a primary focus on SARS-CoV-2 to an unacceptable level of risk. In addition, COVID-19 can have cognitive consequences which would add unnecessary noise to the study data. Testing will continue as long as public health officials and/or NIDA medical personnel deem it appropriate.

Subjects to be considered for Non-Invasive Brain Stimulation (NIBS) will also be excluded if they:

1. Are unable to safely undergo a NIBS procedure due to having epilepsy or being at high risk for a seizure, being sleep deprived, having a history of unexplained fainting, recurrent severe headaches, significant head injury, having undergone a neurosurgical procedure, having metal in the head, having hearing problems or ringing in the ears or implanted medical devices that could malfunction under NIBS.

Additional characterization information will be gathered during screening for some experiments. As this protocol is to develop imaging techniques, this information will be gathered as needed, depending on the phase of development and specific technique requirements, but are not I/E criteria:

Based on the scientific and medical requirements of the particular experiment, participants may also be assessed for:

1. age (Some experiments may want to target a particular age range. For example, cognitive tasks generally exclude participants over 60, an age when cognitive issues tend to become more commonplace)

2. left-handedness (if desired for a particular task),

3. color-blindness (if using a task requiring color discrimination),

4. drug use diagnosis

5. use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used).

6. cognitive impairment as assessed by full scale IQ of 80 measured by the WASI or Shipley-2. 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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Yihong Yang, Ph.D.
National Institute on Drug Abuse (NIDA)
NIDA IRP Office of Human Subjects Research
251 Bayview Blvd, Suite 200
Baltimore, Maryland 21224
(667) 312-5364

Betty Jo Salmeron, M.D.
National Institute on Drug Abuse (NIDA)
(667) 312-5266

Betty Jo Salmeron, M.D.
(667) 312-5266

Clinical Trials Number:


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