Development and Validation of Learning and Decision-Making Tasks

Launched by NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how people learn and make decisions, particularly in the context of substance use disorders. Researchers are trying to create tests that can help us understand these processes better. They are looking for healthy individuals aged 18 to 45 from the Baltimore area to participate. To be eligible, participants need to be in good health and willing to follow the study's procedures. They should also be right-handed if they want to take part in the MRI portion of the study.

Participants will complete various tasks during several visits, which may involve using a computer, smelling different odors, tasting flavored liquids, looking at pictures, and listening to sounds. During these tasks, sensors will monitor their heart rate, blood pressure, and breathing. Some participants may also undergo an MRI scan, which is a type of imaging that allows researchers to see how the brain responds while completing the tasks. Each visit can last from 1 to 7 hours, and the researchers will provide meals if needed. This study is an important step in developing tools that can help researchers learn more about decision-making and learning in the context of substance use.

Gender

ALL

Eligibility 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:
• • 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
• 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.
• EXCLUSION CRITERIA:
• 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 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 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.
• • 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.