RECRUITING

Development and Validation of Learning and Decision-Making Tasks

Conditions

Normal Physiology Behavioral Tasks fMRI Incentive Pocessing Decision Making Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development and Validation of Learning and Decision-Making Tasks

Quick Facts

Study Start:2023-03-29

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05707806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration of the study. * 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. * In good general health. * Agreement to adhere to Lifestyle Considerations throughout study duration	* History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, CNS tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity. * History of current (past 12 months) major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or PTSD. * Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence. * Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks in the past 12 months. * Current use of psychoactive medications and medications that affect alertness and that cannot (in principle) be withheld the night before the study visit. Participants who can withhold these medications will either (1) withhold the medication during this time or (2) not withhold the medication and pass a neuromotor exam on the day of the study visit. Based on participant preferences and MAI/PI judgement, participants who fail the neuromotor exam will either be withdrawn or rescheduled for a date and asked to withhold the medication. * For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the study itself. * Uncorrected impairments in visual acuity. * Non-English speaking. Justification: 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 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 MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants. * Pregnancy. * Any other condition that in the judgment of the investigators is incompatible with participation.

Inclusion Criteria

Exclusion Criteria

* Stated willingness to comply with all study procedures and availability for the duration of the study.
* 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.
* In good general health.
* Agreement to adhere to Lifestyle Considerations throughout study duration

* History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, CNS tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.
* History of current (past 12 months) major DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or PTSD.
* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.
* Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks in the past 12 months.
* Current use of psychoactive medications and medications that affect alertness and that cannot (in principle) be withheld the night before the study visit. Participants who can withhold these medications will either (1) withhold the medication during this time or (2) not withhold the medication and pass a neuromotor exam on the day of the study visit. Based on participant preferences and MAI/PI judgement, participants who fail the neuromotor exam will either be withdrawn or rescheduled for a date and asked to withhold the medication.
* For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the study itself.
* Uncorrected impairments in visual acuity.
* Non-English speaking. Justification: 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 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 MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.
* Pregnancy.
* Any other condition that in the judgment of the investigators is incompatible with participation.

Contacts and Locations

Study Contact

NIDA IRP Screening Team

CONTACT

(800) 535-8254

researchstudies@nida.nih.gov

Thorsten Kahnt, Ph.D.

CONTACT

(667) 312-5175

thorsten.kahnt@nih.gov

Principal Investigator

Thorsten Kahnt, Ph.D.

PRINCIPAL_INVESTIGATOR

National Institute on Drug Abuse (NIDA)

Study Locations (Sites)

National Institute on Drug Abuse

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: National Institute on Drug Abuse (NIDA)

Thorsten Kahnt, Ph.D., PRINCIPAL_INVESTIGATOR, National Institute on Drug Abuse (NIDA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2023-03-29

Study Completion Date2032-12-31

Terms related to this study

Keywords Provided by Researchers

Behavioral Tasks
fMRI
Incentive Pocessing
Decision Making
Natural History

Additional Relevant MeSH Terms

Normal Physiology