Cognitive Task Development and Implementation for Functional MRI Studies

Nicotine Dependence Clinical Trial

Official title: Cognitive Task Development and Implementation for Functional MRI Studies

Status Recruiting

Clinical Trial 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 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....

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Drug Abuse
• Nicotine Dependence
• Substance-Related Disorders
• Tobacco Use Disorder

• NCT number: NCT01036685
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: NIDA IRP Screening Team
• Phone: (800) 535-8254
• Email: researchstudies@nida.nih.gov
• Status: Recruiting
• Start date: May 22, 2005