Craving & Decision-Making

NCT06440577 — Not applicable, Recruiting, 160 participants, Rutgers, The State University of New Jersey

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Decision Neuroscience of Craving

Registry	NCT06440577
Status	Recruiting
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, basic science
Enrollment	160 (Estimated)
Sponsor	Rutgers, The State University of New Jersey (Other); collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Decision Making
Interventions	Audio-visual stimuli (Neutral-Relaxing), Audio-visual stimuli (Drug), Audio-visual stimuli (Non-Food), Audio-visual stimuli (Food) (Behavioral)
Dates	start 2024-06-18, primary completion 2027-12-01 (estimated), completion 2027-12-01 (estimated), first posted 2024-06-04, last updated 2026-06-04
Locations	1 site in United States

-Summary

Craving is the strong desire for something, such as for substances in drug addiction and food or other activities in everyday life. Recent work suggests craving can influence how people make decisions and assign value to choice options available to them, yet the neural mechanisms underlying these interactions between craving and valuation remain unknown. To address this, this study uses cognitive decision-making tasks that measure how much individuals will pay (from a study endowment) to have everyday consumer items or snack foods when they crave something specific (opioids or a specific snack, respectively). First, the study will identify the neural mechanisms for how drug craving (craving for opioids) interacts with valuation for consumer items that have associations with drug use or not in people receiving treatment for opioid use disorder (OUD). This will be evaluated in the activity patterns and interactions among brain regions involved in craving and value assignment during decision-making. Then, the study will examine for parallel mechanisms for how food craving (craving for a specific snack) interacts with valuation for snack food items that have similar features to the craved snack or not in people receiving treatment for OUD and non-psychiatric community control participants.

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+Arms and interventions

Arm	Type	Interventions	Description
Consumer Items Willingness-to-Pay Task	Experimental	Behavioral: Audio-visual stimuli (Neutral-Relaxing); Behavioral: Audio-visual stimuli (Drug)	Men and women with OUD receiving medications for OUD treatment will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for everyday consumer items that have associations with drug use or not. Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and drug craving, via two psychological/behavioral interventions: Audio-visual stimuli (Neutral-Relaxing) and Audio-visual stimuli (Drug).
Snack Foods Willingness-to-Pay Task	Experimental	Behavioral: Audio-visual stimuli (Non-Food); Behavioral: Audio-visual stimuli (Food)	Men and women with OUD receiving medications for OUD treatment and control participants from the community will complete a decision-making task during functional magnetic resonance imaging (fMRI) in which they indicate their willingness-to-pay for snack food items that vary in their features (savory, sweet, etc.). Interleaved with blocks of the task, participants will briefly observe stimuli that can produce a change in their psychological state and food craving, via two psychological/behavioral interventions: Audio-visual stimuli (Non-Food) and Audio-visual stimuli (Food).

Audio-visual stimuli (Neutral-Relaxing) (Behavioral): Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of neutral everyday objects (e.g., tools, dirt) and their use (construction, gardening).
Audio-visual stimuli (Drug) (Behavioral): Audio instruction for participant to allow themselves to experience their feelings followed by 3-min passive viewing of images of drug paraphernalia (e.g., syringe, tourniquet, heroin) and preparation.
Audio-visual stimuli (Non-Food) (Behavioral): Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping an everyday object (e.g., box of crayons) and taking out its contents.
Audio-visual stimuli (Food) (Behavioral): Audio instruction for participant to focus their attention on the experimenter followed by 3-min audio-guided viewing of the experimenter opening/unwrapping a snack (e.g., chocolate bar, bag of chips) and taking out its contents.

+Outcome measures

Primary outcomes

Willingness-to-pay [during the task]: The amount that a participant would be willing to pay for different available choice options. This is measured during the decision-making tasks in which participants are shown images of consumer items or snack foods and report how much they would be willing to pay to have the different items in that moment.
fMRI-BOLD activity measured during willingness-to-pay decisions [during the task]: Functional MRI data will be analyzed to measure changes in blood-oxygen-level-dependent (BOLD) signal in specific regions of interest based on prior research (ventral striatum, ventromedial prefrontal cortex, amygdala, and insula) as participants make willingness-to-pay decisions during each task.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* At least 18 years of age
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* Minimum of 6th grade reading level

Additional inclusion criteria for participants with OUD:

* Primary diagnosis of OUD encompassing heroin and/or painkiller use
* Receiving medications for OUD treatment on an outpatient basis
* At least 12-month history of opioid use

Exclusion Criteria:

* Unable to speak or read English
* Active psychosis or mania
* Current or past schizophrenia diagnosis
* History of intellectual disability or developmental or neurological disorder, seizures or epilepsy, or loss consciousness lasting more than 30 minutes
* Severe medical conditions requiring hospitalization or that, in the opinion of the study staff could compromise study participation
* MRI contraindications (claustrophobia, nonremovable piercings, certain metal in the body etc.) or pregnancy

Additional exclusion criteria for community control participants:

* Positive urine drug screen
* Current or past problematic substance use other than nicotine, and alcohol abuse confined to college or military service
* Current or past bipolar disorder diagnosis
* Use of central nervous system medications within the past 6 weeks (e.g., antidepressants, Ritalin)

+Locations (1)

Facility	City	Country	Status
Rutgers, The State University of New Jersey	Piscataway, New Jersey	United States	Recruiting

+Investigators

Anna Konova, PhD, Principal investigator, Rutgers, The State University of New Jersey

+Funding

NIH grants: R01DA054201