Cognitive Task Development and Implementation for Functional MRI Studies

Background:

• Drugs of abuse have effects on mood, behavior, thinking, and decision making that may encourage people to continue using them and make it difficult for them to stop. Researchers who study these effects are interested in developing new tests to evaluate how drugs and drug use affect different areas of the brain.
• Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and changes to brain function. When specific psychological tests are performed during functional MRI (fMRI) scans, researchers can examine the effects of drug use on the brain. By developing and testing new procedures for fMRI studies, more information can be obtained on brain function and activity in drug-using and non-drug-using individuals, and this information can help develop new treatments and therapies for substance abuse.

Objectives:

- To evaluate the effects of newly developed psychological procedures to be performed during fMRI scans.

Eligibility:

• Healthy volunteers between 13 and 65 years of age who are willing to undergo MRI scanning.
• Both drug-using and non-drug-using individuals will be selected for this study.

Design:

• Before the start of the study, participants will complete questionnaires about medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed during the scanning session(s), and will allow participants to practice the test either on a separate computer or on the computer used during the MRI scan.
• During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks will be performed on a computer in an MRI machine, and may involve receiving rewards (such as money or sips of juice) for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen.
• Participants will receive compensation for their participation in the study, including hourly compensation for individual visits and lump-sum compensation for each MRI scan.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Dependence; Drug Abuse

Detailed Description

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.

The design and piloting of psychological tests and fMRI tasks specifically designed for an adolescent population allows the investigators to determine if the tests/tasks measure theorized cognitive constructs and result in measurable and interpretable fMRI data in adolescents. At this time, the protocol is not enrolling adolescents.

Study Population: This minimal-risk protocol will employ volunteer participants aged 18-65, who must be generally healthy and male or non-pregnant female. In order to ensure applicability to relevant groups, both drug and non-drug 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.

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Thomas Ross, Ph.D.; Phone Number: (443) 740-2645; Email: tross@mail.nih.gov
• Study Contact Backup: Name: NIDA IRP Screening Team; Phone Number: (800) 535-8254; Email: researchstudies@nida.nih.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • National Institute on Drug Abuse, Biomedical Research Center (BRC)
      • Contact: Betty Jo Salmeron, M.D.; Phone Number: 443-740-2651; Email: bsalmeron@intra.nida.nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects must be between the ages of 18-65, be generally healthy and male or non-pregnant female. (Please note that references to adults in this protocol refers to those age 18 and older). There are two levels of inclusion and exclusion criteria; those applying to all participants and those applying to MRI participants only. In addition, some criteria apply to specific populations in which tasks may be piloted. Participants will be considered for one of eight categories: 379-bench-control, 379-bench-smoker, 379-bench-user, 379-bench-other-psych-diagnosis, 379-control, 379-smoker, 379-user, 379-other-psych -diagnosis

Description

• INCLUSION CRITERIA:

Participants will be considered for one of eight categories: 379-bench-control, 379-bench-smoker, 379-bench-user, 379-bench-other-psych-diagnosis, 379-control, 379-smoker, 379-user, 379-otherpsych -diagnosis.

1. Male or female between the ages of 18-65.

2. All subjects must be able to provide informed consent/assent. Additional criteria for specific populations:

   1. 379-smoker- daily smoker of tobacco cigarettes for at least one year (excluding quit attempts)
   2. 379-user- DSM-V substance use disorder on a substance other than nicotine.
   3. 379-other-psych-diagnosis- DSM-V disorder, stable and in treatment (i.e., no medication changes in the previous four weeks and a clearly identified treating psychiatrist).
3. Additional criteria for MRI phase participants:

Right-handed. Assessment tool: Edinburgh Handedness Inventory. Rationale: Left-handed individuals may have lateralization of many brain functions that differ from right-handed individuals who are the majority of the population. Therefore, inclusion of left-handed individuals may add unwanted noise to imaging data.

C) Exclusion Criteria

Bench Only Phase (Does not require MRI. Task requires gathering of accurate behavioral data).

1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment. Assessment tool: phone screen and history and physical (H&P). Rationale: Neurological illnesses are likely to impair performance on the range of tasks to be piloted under this protocol and may impair ability to tolerate the procedures.
2. Current use of psychoactive medications unless required for the psychiatric disorder for which participants in the 379-user and 379-other-psych-diagnosis subcategories are being treated. Assessment tool: phone screen, H&P, Triage, comprehensive urine toxicology. Rationale: psychoactive medications are likely to alter performace 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 (unless task is being evaluated in a specific clinical population). Assessment tool: self report, H&P. Rationale: Current major mood or psychotic disorders are likely to 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.

6. Suspected or confirmed acute 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 http://intranet.cc.nih.gov/hospitalepidemiology/emerging_infectious_diseases.html). Viral testing looking for SARS-CoV-2 in a specimen deemed appropriate by NIH such as nasopharyngeal or mid-turbinate swab. 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. Additionally, participants will be asked about any lingering neurological and psychiatric symptoms such as difficulty with memory or concentration, changes in mood or new anxiety symptoms that may be a result of COVID-19 exposure. The MAI will evaluate any lingering symptoms to determine whether the potential impact on data is compatible with continuing in the study. The MAI will also retain the ability to exclude for a suspicious symptom screen without positive viral test. Rationale: Covid-19 is extremely infectious and can have serious consequences. Allowing participants with acute 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. Screening and testing will continue as long as public health officials and/or NIDA medical personnel deem it appropriate.

   Additional criteria for MRI:

7. Pregnancy. Assessment tool: Urine pregnancy test. Rationale: Since the hormonal changes of pregnancy have been shown to have an impact on cognitive functioning and the tasks we are developing may yield only subtle differences between control and drug abusing subjects, we need to minimize any extraneous variation in the pilot data. Additionally, fMRI is not accepted as a safe procedure purely for research purposes during pregnancy.
8. Deep vein thrombosis: Assessment tool: self report during H&P of thrombosis, or a medical condition that may lead to a hypercoagulable state Rationale: Lying still for >2 hours may be a risk for the development of DVT in persons with certain medical conditions. As such, persons with will be excluded.
9. HIV positive individuals. Assessment tool: oral HIV test with serum confirmation of positive results. Rationale: potential for cognitive and/or other CNS disease that makes performing cognitive tasks non-reliable and /or non generalizeable to the general population. Also, potential liver/metabolic/vascular disease can interfere with the physiological transduction mechanisms for fMRI (i.e. making the measurement unreliable).
10. Unable to undergo MRI scanning due to possible pregnancy, metallic devices in the body, claustrophobia or body morphometry.
11. Currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
379-bench-control; healthy control who will only do behavioral tasks
379-bench-other-psych-diagnosis; someone with a DSM-V disorder, stable and in treatment (i.e., no medication changes in the previous four weeks and a clearly identified treating psychiatrist) who will only do behavioral tasks
379-bench-user; someone with a DSM-V substance use disorder on a substance other than nicotine who will only do behavioral tasks
379-bench-smoker; daily smoker of tobacco cigarettes for at least one year (excluding quit attempts) who will only do behavioral tasks
379-control; healthy control who can do MRI
379-other-psych -diagnosis; someone with a DSM-V disorder, stable and in treatment (i.e., no medication changes in the previous four weeks and a clearly identified treating psychiatrist) who can do MRI
379-smoker; daily smoker of tobacco cigarettes for at least one year (excluding quit attempts) who can do MRI
379-user; someone with a DSM-V substance use disorder on a substance other than nicotine who can do MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine if the tasks reliably and appropriately measure specific cognitive constructs and behaviors thought to be associated with specific brain systems and, also if they yield measurable and interpretable fMRI results.	yield measurable and interpretable fMRI results	each visit

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Thomas Ross, Ph.D., National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2005

Study Registration Dates

• First Submitted: December 18, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimated): December 21, 2009

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: July 7, 2023

More Information

Terms related to this study

• Keywords: Adolescents; Natural History; fMRI; Cognition; Affect; Task Development
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: 999903379; 03-DA-N379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: .There is no plan to share raw data from the study as this is a task development protocol in which the objective is 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 for future protocols.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No