Cognitive Task Development and Implementation for Functional MRI Studies

Objective: Drugs of abuse have cognitive and affective effects that may contribute to the inception and maintenance of their use. In order to measure these effects, psychological tests suitable for use both in and outside the fMRI scanner need to be developed and validated. Thus, the objective of this protocol is to allow for the development, assessment and refinement of cognitive and affective tasks and determination of their practical feasibility and efficacy for both MRI and non-MRI application.

Study Population: This minimal-risk protocol will employ volunteer participants aged 18-65, who must be generally healthy. In order to ensure applicability to relevant groups, both drug and nondrug using volunteers as well as those recruited from clinical populations will be used to validate task design and parameters.

Design: Participants may pilot tasks outside and/or inside the MRI scanner, depending on the aspects of task development requiring verification. Tasks developed de novo will undergo both steps. Modifications to previously published MRI tasks may require only one of the steps. Upon their successful verification, specific experimental manipulations will be performed under separate, hypothesis driven protocols.

Outcome measures: Our goal is to determine if the tasks developed reliably and appropriately measure specific cognitive constructs and behaviors thought to be associated with specific brain systems, if they yield measurable and interpretable fMRI results.

• 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:

• Between the ages of 18-65.
• All subjects must be able to provide informed consent/assent.
• Additional criteria for specific populations:

• 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)
• 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).

• 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.

• 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.
• 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.
• 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.
• 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.