Developing and validating tasks for learning and decision-making
Development and Validation of Learning and Decision-Making Tasks
This study is testing new tasks to see how people with substance use disorders learn and make decisions, using activities that may involve brain scans to understand their responses better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 550 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05707806 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop and validate behavioral tasks that assess how individuals learn and make decisions, particularly in the context of substance use disorders. Participants, aged 18-45 from the Baltimore area, will engage in various tasks over multiple study visits, some of which may involve functional MRI (fMRI) to observe brain activity. The study seeks to create reliable measures of cognitive functions that can be used in future research on incentive processing and decision-making. The tasks will include stimuli such as smells and flavors to evaluate participants' responses.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals aged 18-45 years who are willing to comply with study procedures.
Not a fit: Patients with substance use disorders or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and assessment of decision-making processes in individuals, potentially aiding in the prevention and treatment of substance use disorders.
How similar studies have performed: While the approach of developing behavioral tasks is common, the specific focus on incentive processing in relation to substance use disorders is a novel aspect of this study.
Eligibility criteria
Show full inclusion / exclusion 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.
EXCLUSION CRITERIA:
Individuals who meet any of the following criteria will be excluded from participation:
1. 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.
2. 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.
3. 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.
4. Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks in the past 12 months.
5. 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.
6. 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.
7. Uncorrected impairments in visual acuity.
8. 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.
9. Pregnancy.
10. 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:
11. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.
Where this trial is running
Baltimore, Maryland
- National Institute on Drug Abuse — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Thorsten Kahnt, Ph.D. — National Institute on Drug Abuse (NIDA)
- Study coordinator: NIDA IRP Screening Team
- Email: researchstudies@nida.nih.gov
- Phone: (800) 535-8254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.