Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Dec 18, 2009

Keywords

ClinConnect Summary

This clinical trial is studying how advanced MRI techniques can help researchers better understand the effects of drug addiction, particularly focusing on nicotine dependence. By using MRI scans, the goal is to learn how these substances change brain function and structure, which can lead to improved treatments for addiction. Researchers are looking for participants aged 18 to 80, whether they smoke, use drugs, or not, as long as they are generally healthy and can provide informed consent.

Participants in the trial can expect to complete questionnaires about their personal and family history, as well as their drug use. They will undergo a 2-hour MRI scan, during which they may be asked to perform specific tasks. To ensure safety, participants will also have some tests prior to the MRI, including urine tests and breathalyzer tests. It's important to note that certain individuals, such as those with significant medical or psychiatric conditions, or those who are pregnant, will not be eligible to join the study. Overall, this research aims to develop new ways to better understand and treat addiction.

Gender

ALL

Eligibility criteria

• • 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.
• INCLUSION CRITERIA:
• General:
• • Male and non-pregnant female adults between the ages of 18-80.
• • 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 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. Participants will also be asked about any lingering neurological and psychiatric symptoms that may be a result of COVID-19 infection. 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 the consent quiz and 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.
• Subjects to be considered for Non-Invasive Brain Stimulation (NIBS) will also be excluded if they:
• • -Are unable to safely undergo a NIBS procedure as assessed by a TMS safety screening form.
• Additional information will be gathered during screening for some experiments. As the purpose of this protocol is to develop imaging techniques, this information will be gathered as needed, depending on the phase of development and specific technique requirements. Based on the scientific and medical requirements of the particular experiment, participants may also be assessed for:
• • 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)