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Cognitive Task Development and Implementation for Functional MRI Studies

Recruiting
Conditions
Drug Abuse
Nicotine Dependence
Registration Number
NCT01036685
Lead Sponsor
National Institute on Drug Abuse (NIDA)
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....

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.

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
750
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.each visit

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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

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

🇺🇸

Baltimore, Maryland, United States

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

🇺🇸

Baltimore, Maryland, United States

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