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Development and Validation of Learning and Decision-Making Tasks

Development and Validation of Learning and Decision-Making Tasks

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05707806
Enrollment
550
Registered
2023-02-01
Start date
2023-03-29
Completion date
2032-12-31
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Physiology

Keywords

Behavioral Tasks, fMRI, Incentive Pocessing, Decision Making, Natural History

Brief summary

Background: Substance use disorders (SUD) can be considered disorders in the way people process incentives, learn, and make decisions. To understand why some people develop SUD, researchers need to develop reliable tests that show how people think and learn. This natural history study seeks to develop a set of tasks that could then be used to test how people learn and make decisions. Objective: To develop and validate behavioral tasks that could be used in future studies. Eligibility: Healthy people aged 18-45 years from the Baltimore area. They must also be enrolled in the NIDA screening protocol. Design: Participants will perform different tasks. Most tasks require 1-4 study visits; some may require up to 12. Visits are 1-14 days apart. All visits will last about 1-7 hours. Participants will perform tasks on a computer. As they work they may be given different stimuli: Smells. Participants will sniff odors through a plastic tube or mask on their nose. Flavors. Participants will wear a mouthpiece and small amounts of different flavored liquids will be placed in their mouth. Pictures. Participants will look at different images. Sounds. Participants will wear headphones and various sounds will be played for them. Food. Participants may be asked to eat a meal before, during, or after a task. The researchers will provide the meal. During each task, participants will wear sensors to monitor their heart rate, blood pressure, breathing, and other physical changes in their bodies. Some participants will have a functional magnetic resonance imaging (fMRI) scan. They will lie on a table that slides into a cylinder. They will perform tasks on a computer screen during the fMRI.

Detailed description

Study Description: From a behavioral perspective, substance-use disorders (SUD) can be considered as disorders of incentive processing, learning, and decision-making. The Learning and Decision-Making Unit at NIDA IRP conducts Basic Experimental Studies involving Humans (BESH) to study the neurocomputational mechanisms underlying these functions, and their disruption in SUD. For this, behavioral tasks suitable for use both in and outside the functional magnetic resonance imaging (fMRI) scanner need to be developed and validated. Objectives: The primary objective of this protocol is to develop and validate behavioral tasks inside and outside the fMRI scanner, and to determine their practical feasibility for future studies. Endpoints: The primary endpoint is to determine if the developed tasks reliably and appropriately measure specific cognitive functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.

Interventions

DEVICEMRI

Enables the use of custom pulse sequence

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: There are two levels of inclusion and

Exclusion criteria

; those applying to all participants and those applying to participants in the 'MRI' phase only. Participants will be cleared for both the behavioral and MRI phases, if eligible, and will be invited to sign one or both consents depending on what tasks are active at the time of consent. If a person is not MRI compatible, they will only be offered enrollment into the behavioral phase of the study. In order to be eligible to participate in this study, an individual must meet the following criteria: 1. Male or female, aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. 2. In good general health. In order to be eligible to participate in the MRI phase of this study, an individual must - in addition - also meet all of the following criteria: 3. Right-handed.

Design outcomes

Primary

MeasureTime frameDescription
task performanceeach study visitto determine if the developed tasks reliably and appropriately measure specific cognitive functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.

Countries

United States

Contacts

CONTACTNIDA IRP Screening Team
researchstudies@nida.nih.gov(800) 535-8254
CONTACTThorsten Kahnt, Ph.D.
thorsten.kahnt@nih.gov(667) 312-5175
PRINCIPAL_INVESTIGATORThorsten Kahnt, Ph.D.

National Institute on Drug Abuse (NIDA)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026