Normal PhysiologyNCT05707806
Development and Validation of Learning and Decision-Making Tasks
An observational study of Normal Physiology, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2023to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: local community sample: metropolitan Baltimore area
Who may be able to join
- 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:
- 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.
- 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:
- Right-handed.
Who cannot join
- Individuals who meet any of the following criteria will be excluded from participation:
- 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 currently unresolved psychiatric disorders with current (past 12 months) regular use of psychiatric medications. Past/remitted (>12 months ago) psychiatric disorders with no currently active symptoms and no current use of psychiatric medications may be included in the study, per MAI discretion.
- 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 clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgement, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled and asked to withhold the medication.
Show all 13Show fewer
- 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.
- An individual who meets any of the following criteria will be excluded from participation in the MRI phase of this study:
- Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institute on Drug Abuse
Baltimore, Maryland, 21224
Thorsten Kahnt, 667-312-5175, thorsten.kahnt@nih.gov
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Normal Physiology
- Being tested
- MRI
- Keywords
- Behavioral Tasks, fMRI, Incentive Pocessing, Decision Making, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Enables the use of custom pulse sequence
| Study group | Role | What they receive |
|---|---|---|
| healthy controls | generally healthy volunteers Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
task performance
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.
Measured: each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start29 Mar 2023
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thorsten Kahnt, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707806
- Sponsor's protocol ID
- 10001156
- Other IDs
- 001156-DA
- Status last verified
- 24 Sep 2026
- First submitted
- 31 Jan 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share raw data from the study as this is a study to develop and validate behavioral tasks, to determine if they can reliably and appropriately measure specific functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Learning and Decision-Making Tasks
- ClinicalTrials.gov ID
- NCT05707806
- Acronym / sponsor ID
- 10001156
- Conditions
- Normal Physiology
- Keywords
- Behavioral Tasks, fMRI, Incentive Pocessing, Decision Making, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy controls | – | Device: MRIgenerally healthy volunteers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- local community sample: metropolitan Baltimore area
Key inclusion criteria (6 listed)
- 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:
- 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.
- 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:
Key exclusion criteria (13 listed)
- 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 currently unresolved psychiatric disorders with current (past 12 months) regular use of psychiatric medications. Past/remitted (>12 months ago) psychiatric disorders with no currently active symptoms and no current use of psychiatric medications may be included in the study, per MAI discretion.
- 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 clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgement, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled and asked to withhold the medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIEnables the use of custom pulse sequence | Device | healthy controls |
Primary outcome
task performance
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to share raw data from the study as this is a study to develop and validate behavioral tasks, to determine if they can reliably and appropriately measure specific functions, and if they yield measurable and interpretable fMRI results in the associated brain systems.
Related trials for Normal Physiology
RecruitingEarly Phase 1
Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making
Normal Physiology
RecruitingObservational study
Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer
Non-GI Cancers, Cancer of Gastrointestinal Tract
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
Not yet recruitingEarly Phase 1
Causal Mechanisms of Odor-Guided Behavior in Humans
Normal Physiology
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thorsten Kahnt, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Physiology, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NIDA IRP Screening Team ((800) 535-8254, researchstudies@nida.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
task performance (time frame: each study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.