Advanced MRI Techniques for Neuropharmacological Imaging in Drug Abuse and Nicotine Dependence

This study aims to improve how we use advanced magnetic resonance imaging (MRI) to understand the brain, especially in people with drug abuse or nicotine dependence. Researchers are developing new ways to use MRI scanners like the Magnetom Prisma Fit 3T Scanner to get clearer images and better information about brain activity. They are also exploring how devices like the MagPro X100 Magnetic Stimulator and Transcranial Rotating Magnetic Stimulator affect the brain. The goal is to create better tools for studying how addiction changes the brain and to find more effective treatments. This study is open to generally healthy adults aged 18-80, including smokers, non-smokers, and people who use drugs.

Study design
This interventional study plans to enroll 1000 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Primary endpoints are measured at each visit, but no specific follow-up period after treatment is mentioned.

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NCT01036581

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Recruiting
NAAges 18–80InterventionalBasic science
National Institute on Drug Abuse (NIDA)
~1,000 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:MagPro X100 Magnetic StimulatorTranscranial Rotating Magnetic StimulatorMagnetom Prisma Fit 3T Scanner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To develop a simultaneous perfusion and BOLD imaging technique with improved functional contrasts and reduced susceptibility artifacts for determination of CMRO2 during brain activation
Measured over at each visit
+5 more outcomes measured
Drug Abuse
Nicotine Dependence
1 sites across 1 states
Maryland1
  • Yihong Yang, Ph.D. · PRINCIPAL_INVESTIGATOR · National Institute on Drug Abuse (NIDA)

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Eligibility criteria

Inclusion

Male and non-pregnant female adults between the ages of 18-80.
All subjects must be able to provide informed consent.

Exclusion

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 severe enough to impact data being gathered. Potential exclusions may include a history of chronic uncontrolled hypertension, diabetes, HIV, or other clinically significant medical conditions 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 severe enough to impact data being gathered. Potential exclusions may include seizure disorders, migraine, multiple sclerosis, movement disorders, or history of significant head trauma, CVA, or CNS tumor. The MAI will assess the severity in relation to the potential impact on data.
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.
Are cognitively impaired, as assessed by medical history. A validated IQ test such as the WASI or Shipley-2 may also be considered. 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. Cognitive impairment may affect one s ability to give informed consent.
Are unable to safely undergo a NIBS procedure as assessed by a TMS safety screening form.
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)
Left-handedness (if desired for a particular task)
Color-blindness (if using a task requiring color discrimination)
Drug use diagnosis
Use of psychoactive or vascularly active medications (if a functional fMRI technique that is sensitive to hemodynamic changes is being used). MAI discretion regarding timeframe of allowed use will be based on clinically relevant factors including drug half-life, pharmacology of the drug in question and pattern of use by the participant.
  • To develop a simultaneous perfusion and BOLD imaging technique with improved functional contrasts and reduced susceptibility artifacts for determination of CMRO2 during brain activationat each visit

    perfusion/BOLD imaging data

  • To develop efficient methods to reduce image artifacts caused by susceptibility-induced field inhomogeneity and head motion, and therefore to improve reliability and sensitivity of functional imagingat each visit

    MRI scan data

  • To develop an imaging technique to identify fiber crossing in the brain based on high-angular resolution measurements of apparent diffusion coefficient (ADC), and subsequently to develop improved fiber tracking techniques to delineate neuronal p...at each visit

    MRI scan data

  • To develop MRS techniques that are able to reliably measure metabolite and neurotransmitter concentrations in the brain at 3 Tesla, and to evaluate their feasibility and efficacy in drug addiction studiesat each visit

    MRS data from MRI scans

  • To integrate genetic analysis with morphological and functional measurement of the amygdala, hippocampus, and other regions, which may help to account for some of the noise in these measurementsat each visit

    MRI scan data and blood samples collected in 380 or 457 (NRB genetics protocol).

  • To assess effects of neuromodulation techniques, such as TMS and TRPMS, on brain activity and relevant MRI signalsat each visit

    MRI scan data; spontaneous motor unit potentials (sMUPs) in the contralateral abductor pollicis brevis muscle (APB)