Cognitive Task Development and Implementation for Functional MRI Studies

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

Keywords

ClinConnect Summary

This clinical trial is studying how drug use, particularly nicotine dependence, affects the brain's function and behavior. Researchers are using a special type of MRI scan, called functional MRI (fMRI), to see how different tasks impact brain activity in both individuals who use drugs and those who don’t. By developing new psychological tests to use during these scans, the aim is to gather more information that could lead to better treatments for substance abuse.

Healthy volunteers aged 13 to 65 who are willing to undergo MRI scanning can participate in this study. Participants will complete questionnaires about their medical history and drug use, and they will perform tasks on a computer while inside the MRI machine. These tasks may involve memory tests or earning rewards. Participants will be compensated for their time, including hourly pay and additional payments for the MRI scans. If you're interested in joining, it’s important to know that there are specific eligibility criteria, such as being between 18-65 years old and not having certain medical conditions that could affect the study results.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Bench Only Phase (no MRI)
• • Participants will be considered for one of three categories: 379-bench-control, 379-bench-smoker/vaper, 379-bench-user. Vapers will be admitted to experiments involving smoking cues (with cues specific to vaping) because it has been shown that responses to vaping cues are very similar to responses to smoking cues and can be lumped together in analyses.
• Participant must meet the following inclusion criteria for the Bench Only Phase:
• • 1. Between the ages of 18-65.
• • 2. All subjects must be able to provide informed consent/assent.
• 3. Additional criteria for specific populations:
• • 1. 379-bench-smoker/vaper: regular smoker of tobacco cigarettes or nicotine vaper with a urine cotinine level corresponding to nicotine user status for the specific test being used (typically corresponding to a urine cotinine above about 200 ng/ml) and have been smoking or vaping consistently for at least one year (excluding quit attempts)
• • 2. 379-bench-user: DSM-V substance use disorder on a substance other than nicotine.
• EXCLUSION CRITERIA:
• • Bench Only Phase (Does not require MRI. Task requires gathering of accurate behavioral data).
• • 1. History of neurologic injury including but not limited to CVA, CNS tumor, or head trauma with persistent sequelae. Assessment tool: pre-screen survey and medical history.
• • Rationale: Neurologic injury is likely to impair performance on the range of tasks to be piloted under this protocol.
• • 2. Current use of psychoactive medications likely to affect the performance of the task under consideration, unless required for the psychiatric disorder for which participants in the 379-user and 379-other-psych-diagnosis subcategories are being treated. Assessment tool: pre-screen survey, medical history. Rationale: certain psychoactive medications may alter performance on the range of tasks to be piloted under this protocol.
• • 3. Cognitive impairment. Assessment tool: self report of extended placement in special education classes for learning problems, history of specific learning disability or mental retardation. Rationale: Cognitive impairment is likely to impair performance on the range of tasks to be piloted under this protocol and may impair ability to tolerate the procedures.
• • 4. Current major mood, anxiety or psychotic disorder with symptoms severe enough to impair ability to participate (unless task is being evaluated in a specific clinical population). Assessment tool: self report, medical history. Rationale: Current major mood or psychotic disorders with poorly controlled symptoms may impair performance on the range of tasks to be piloted under this protocol and may impair ability to tolerate the procedures.
• • 5. Non-English speaking. Assessment tool(s): self-report. Rationale: 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 study procedures. The inability to effectively communicate safety procedures in a language other than English could compromise the safety of non-English speaking participants.