Development and Validation of Learning and Decision-Making Tasks

Recruiting

• Conditions: Normal Physiology
• Interventions: Device: MRI

• Registration Number: NCT05707806
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-01
• Study Start: 2023-03-29
• Status Verified: 2025-05-12
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2032-12-31
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	MRI	generally healthy volunteers

Primary Outcome Measures

Name	Time	Method
task performance	each study visit	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.

Trial Locations

Locations (1)

National Institute on Drug Abuse; 🇺🇸 Baltimore, Maryland, United States