Clinical trial NCT06440577: Craving & Decision-Making
Official title: Decision Neuroscience of Craving
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Making
Keywords: Craving
Decision Making
Opioid Use Disorder
Dietary Choice
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-06-04
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Men and women with OUD receiving medications for OUD treatment will complete both the Consumer Items Willingness-to-Pay Task and Snack Foods Willingness-to-Pay Task at two separate task sessions. Non-psychiatric community control participants will complete the Snack Foods Willingness-to-Pay Task.
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Willingness-to-pay
timeFrame: during the task
measure: fMRI-BOLD activity measured during willingness-to-pay decisions
timeFrame: during the task
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Anna Konova, PhD
role: PRINCIPAL_INVESTIGATOR
References: