Cognitive Task Development and Implementation for Functional MRI Studies

NCT01036685 | Completed

• 2 other identifiers: 99990337903-DA-N379
• Study Type: observational
• Target: 525
• Locations: 1 country
• Sites: 1

Brief Summary

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 develop, assess and refine of cognitive and affective tasks and determination of their practical feasibility and efficacy for both MRI and non-MRI application. Eligibility:
• Healthy volunteers between 18 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 may complete as assessment of medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed and may have participants practice the tasks.
• During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks may 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.

Conditions

Drug Abuse; Nicotine Dependence

Keywords

Task Development; Natural History; fMRI; Cognition; Affect

Outcome Measures

Primary Outcomes (1)

• 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.

  1\. To derive the parameters necessary to determine the reliability and validity of cognitive tasks.2. To determine the ability of various control and target populations to perform the tasks appropriately in and out of the MRI scanner.3. To determine the task parameters optimal for the activation of specific brain regions when employed during fMRI scanning.

  each visit

Study Arms (8)

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-smoker

daily smoker of tobacco cigarettes for at least one year (excluding quit attempts) 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-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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects must be between the ages of 18-65 and be generally healthy. (Please note that references to adults in this protocol refers to those age 18 and older). Depending on the task being developed and specific task goals, they may have a substance use disorder or have no history of substance use.

You may qualify if:

• 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.
• Between the ages of 18-65.
• All subjects must be able to provide informed consent/assent.
• Additional criteria for specific populations:
• 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)
• bench-user: DSM-V substance use disorder on a substance other than nicotine.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Thomas J Ross, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: May 22, 2005
• Last Updated: June 4, 2026

Record last verified: 2026-03-24

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)