Craving & Decision-Making

Decision Making Clinical Trial

Official title:

Decision Neuroscience of Craving

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440577
• Other study ID #: Pro2018002176
• Secondary ID: R01DA054201
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Anna Konova, PhD
• Phone: 732-235-4335
• Email: anna.konova[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Decision Making

Intervention

Behavioral:
• Audio-visual stimuli (Neutral-Relaxing)
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)
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)
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)
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.

Locations

Country	Name	City	State
United States	Rutgers, The State University of New Jersey	Piscataway	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness-to-pay	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.	during the task
Primary	fMRI-BOLD activity measured during willingness-to-pay decisions	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.	during the task